CHAPTER - 7 STUDIES AT KLE UNIVERSITY...

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SECTION-II 7 : Studies at KLEUH 56 CHAPTER - 7 STUDIES AT KLE UNIVERSITY HOSPITAL After ensuring that the equipments and accessories were available in adequate number we practiced and acquired the skill of attaching the probes quickly without disturbing the routine care of the newborn. Two nursing staff were identified and were also trained in this protocol. Further they also received training in maintenance of equipment, ensuring that good signal and waveform were being displayed on the screen, and that the probes were attached properly through out the monitoring in the DR, during transfer from DR to PNW and later in the PNW. We then decided to embark on our study. To begin with, we studied the time motion of mother in labor and Newborn: Mother was shifted to the delivery room when in established labor. She was monitored by the attending resident and nurse. CTG monitoring was done if necessary. Pediatric resident was also simultaneously informed about the progress of the patient. Delivery was conducted by the senior resident; consultant was called in presence of any complications or when there was need for assisted delivery. Newborn resuscitation team comprised of a registrar, a resident and a nurse trained in NRP 2006protocol. [134] The investigator and resuscitation team worked independently during the study period but the team was not blinded to the data that was monitored. Routinely, the team provided required care to the newborn under radiant warmer, dried and wrapped the baby in the piece of cloth brought by the relatives which was either from thin dhoti, cotton saree (40%), polyester or any other synthetic material (60%). The newborn infant was wrapped in three folds which covered the head partially. Diapers and head caps were not used. The baby was kept

Transcript of CHAPTER - 7 STUDIES AT KLE UNIVERSITY...

  • SECTION-II 7 : Studies at KLEUH

    56

    CHAPTER - 7

    STUDIES AT KLE UNIVERSITY HOSPITAL

    After ensuring that the equipments and accessories were available in adequate

    number we practiced and acquired the skill of attaching the probes quickly without

    disturbing the routine care of the newborn. Two nursing staff were identified and were

    also trained in this protocol. Further they also received training in maintenance of

    equipment, ensuring that good signal and waveform were being displayed on the

    screen, and that the probes were attached properly through out the monitoring in the

    DR, during transfer from DR to PNW and later in the PNW. We then decided to

    embark on our study.

    To begin with, we studied the time motion of mother in labor and Newborn:

    Mother was shifted to the delivery room when in established labor. She was

    monitored by the attending resident and nurse. CTG monitoring was done if

    necessary. Pediatric resident was also simultaneously informed about the progress of

    the patient. Delivery was conducted by the senior resident; consultant was called in

    presence of any complications or when there was need for assisted delivery.

    Newborn resuscitation team comprised of a registrar, a resident and a nurse

    trained in NRP 2006protocol.[134]

    The investigator and resuscitation team worked

    independently during the study period but the team was not blinded to the data that

    was monitored. Routinely, the team provided required care to the newborn under

    radiant warmer, dried and wrapped the baby in the piece of cloth brought by the

    relatives which was either from thin dhoti, cotton saree (40%), polyester or any other

    synthetic material (60%). The newborn infant was wrapped in three folds which

    covered the head partially. Diapers and head caps were not used. The baby was kept

  • SECTION-II 7 : Studies at KLEUH

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    under warmer till mother was ready to receive the baby for breast feeding. This period

    varied from 40 minutes to one and half hour depending on the time taken for

    stabilization of the mother. A clinical examination to rule out any obvious life

    threatening anomalies was performed by the resident on each baby. Injection Vitamin

    K 1 mg intramuscular was given to all the babies.

    Baby was encouraged to suckle at the breast when kept with the mother

    wrapped in the cloth and was monitored for signs of respiratory distress and proper

    attachment at the breast. The baby and mother were kept in the DR for minimum 2

    hours (2 1/2-4 hours average 3 hours) before they were shifted to the postnatal ward.

    All infants weighing ≤ 2200 grams were shifted to the Kangaroo mother care ward.

    Stable infants weighing >2200 grams were shifted to the PNW with the mother.

    It is the norm in the Indian family that each mother is accompanied by an

    experienced relative (her mother, sister or aunt) who takes over the care of the

    newborn allowing the mother to take rest. This was followed in our community also.

    All the babies were exclusively breast fed on demand. Generally primi mothers

    preferred to feed the baby in lying down position which allowed them to take rest.

    Experienced mothers breast fed the baby sitting up by placing the baby on the lap.

    During the study period the PNW in the hospital was a general 60 bed, open

    ward, for mothers and newborns with no air conditioning or central heating system.

    Windows of the unit were open or closed depending on the weather conditions. As

    per local practice, infants did not wear a cap, shirt or socks. Infants were co-bedded

    with mother. Infants were wrapped in the cloth, which partially covered their head

    and were covered with same blanket as that of the mother. All the infants were

    exclusively breast fed on demand, and breast-feeding was not interrupted during the

    study. Change of wet and soiled clothing was done as needed.

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    Routine monitoring of the baby was done by the nurse in PNW and

    encouraged exclusive breast feeding.

    The hospital having accepted Baby friendly

    initiative, it was the hospital policy not to

    advocate top milk for well term normal

    newborns in the postnatal ward. Babies did

    not receive bath during the hospital stay.

    The baby was discharged from the

    postnatal ward along with the mother in 3-5

    days.

    7.1. METHODOLOGY

    We carried out feasibility study on 5 infants delivered at KLEUH (TCH) to

    test the study protocol and to get acquainted with the use of equipments. After

    delivery, the newborn infant was received in a tray covered with warm hospital cloth

    and time of birth and time taken to clamp the cord was noted. After cutting the cord

    the infant was placed on the resuscitation trolley under the radiant warmer and care

    was given as per NRP 2006 guidelines by the team assigned for resuscitation. The

    monitoring was initiated by the investigating team as described under

    methodology.(Fig 7.1)

    Monitoring of other Physiologic Parameters

    After the oxygen sensor and temperature probes were securely attached to the

    baby we attached disposable neonatal BP cuff 3cm × 9cm for non invasive blood

    pressure monitoring to the left upper limb. After application of the cuff, baby was

    Fig 7.1. Monitoring of the newborn under

    warmer. BP cuff is attached to the left

    arm.Temperature probes are placed on

    abdomen & right foot. SpO2 sensor is

    attached to right palm.

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    settled by gentle stroking or allowing sucking at his/her fingers. The left hand was

    gently placed in semi flexed to extended position and BP was recorded. If no

    recording was obtained in 2 attempts at 2 minutes interval due to movements of the

    baby then no further attempts were made till baby settled down. The study protocol

    was planned to monitor blood pressure every 15 minutes starting from 5 minutes of

    birth for first one hour and then every four hours till 12 hours from birth. This was not

    possible when baby was feeding or crying and hence we obtained NIBP recordings

    whenever feasible with standard protocol.

    The baby was assessed for following clinical parameters regularly at 5, 15, 30

    minutes, one hour, 2-4 hours, 6-8 hours & 10-12 hours. Intervals were chosen not to

    disturb the baby and mother while resting. All the details were entered in the clinical

    assessment protocol which was prepared for the study. (Annexure-III-A)

    1. Color was noted over the tongue, palms and soles and marked as pink or blue.

    Any color other than pink (pale, dusky) was recorded as blue. The recognition of

    color was done by the investigator and/or by another Pediatrician who had

    agreement on the labeling it as pink or blue after practicing over 10 babies.

    Simultaneous SpO2 was recorded in the patient chart.

    2. Temperature was assessed by placing the dorsum of

    hand over the trunk, palms and soles and was recorded

    as cold or warm. Simultaneous abdominal and foot

    temperature was noted. (Fig 7.2)

    3. Capillary refill time (CRT) was assessed at three points

    i.e. midpoint of sternum, midpoint of left palm and sole

    Fig 7.2. Human Touch method for

    clinical assessment of Temp

    Fig 7.3.Assessment of CRT on sole

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    Stop watch was started, moderate pressure to blanch

    the skin was applied for 5 seconds and released.

    Capillary refill was counted in seconds. Simultaneous

    Blood pressure was noted. (Fig 7.3) Room temperature &

    humidity were also noted at regular intervals during

    the study using standard Thermo-Hygro clock (MEXTECH M288CTH JAPSIN

    Instrumentation, India) (Fig 7.4)

    Care in the Delivery Room:

    Initially infants were wrapped in a cloth and kept under warmer with 40%

    heater output. All the babies were wrapped

    in a single piece of cloth brought by the

    relatives. They were then given to the

    mother for breast-feeding at mean (SD) age

    of 0.75(0.5) hours after birth (Fig 7.5) and

    remained with the mother until transfer to

    postnatal ward (PNW). After stabilization,

    both mother and newborn infant were

    transferred to PNW with all the electronic

    attachments to the baby. Mean time of transfer from DR to PNW was 2.5(0.8) hours

    from birth, and mean (SD) time taken to transfer was 15(8) minutes.

    Fig 7.4. MEXTECH

    Thermohygroclock

    Fig 7.5. Monitoring of the newborn in DR

    with mother. Baby is placed next to the

    mother wrapped in a cloth after first

    breast feed

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    Care in Post Natal Ward:

    Mother and baby dyad was wheeled in to

    the postnatal ward with all the attachments to the

    baby and uninterrupted electronic monitoring. They

    were co- bedded as per the routine practice in the

    postnatal ward and baby and mother were covered

    with same blanket. (Fig7.6) Breast feeding was

    continued uninterruptedly. The probe wires were

    long enough to allow moving the baby on the bed.

    Electronic monitoring was thus continued for

    12 hours. Mother and her attendant were also

    shown various parameters that were being monitored. If the probes got detached or

    good waveform was not seen on the monitor, the probes were reattached, oxygen

    saturation sensor replaced and the time noted to cancel those readings from the final

    data analysis. After each completed study, the data was downloaded from the monitor

    via USB port and transferred to a computer for processing.

    With this experience of feasibility study, the time intervals for clinical

    assessment of the babies were modified and the time for recording blood pressure was

    also grouped in time intervals from birth to 12 hours. Our protocol initially included

    record of the time of specific activities such as feeding, change of clothing etc by

    mother. We found that the mothers were not much interested and they preferred to

    rest during first 12 hours. Hence we deleted this record from assessment protocol. The

    revised protocol was submitted to and approved by the ethical committee of the KLE

    University.

    Fig 7.6. Monitoring of the newborn

    in PNW. Mother & baby are co-

    bedded and covered with same

    blanket.

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    Phase I Study:

    This was carried out from July 2008 to September 2008 in the TCH which is a

    rainy season in India. The analysis of data showed significant hypothermia in

    newborns delivered in TCH (discussed later page no.77 to 81). To understand the

    effect of seasonal variation we carried out Phase II of the study after rainy season.

    Phase II Study:

    This was carried out in the TCH from January 2009 to March 2009 which is

    recognized by the local weather authority as spring season. We followed the same

    protocol as in the Phase I study for enrollment and monitoring of the newborns.

    We analyzed the data on electronic monitoring to understand the trends in

    physiological parameters during transitional adaptation by infants delivered in TCH.

    7.2. RESULTS OF PHYSIOLOGIC PARAMETERS MONITORED AT

    KLEUH SITE:

    600 deliveries occurred from July 2008 to October 2008 at this site. This being

    a tertiary referral center, 50% deliveries were of antenatally detected high risk

    mothers and hence excluded from the study. Of the rest mothers with no antenatal risk

    factors, 40% needed some assistance during labor, 20% deliveries occurred at night

    when all the necessary arrangements prior to the delivery were not possible and 10%

    babies needed help in the form of free flow oxygen or bag and mask ventilation. With

    these exclusion criteria being strictly followed we had a convenience sample of 30

    infants over 3 months period in phase I and 38 infants in phase II study.

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    7.2. A. Demographic Characteristics

    Of the 30 infants enrolled in phase I study, 8 infants were excluded due to

    inadequate data collection or technical difficulties in data collection. Additionally 2

    parents did not give consent to continue monitoring for 12 hours. The data of the

    remaining 20 infants was included in the data analysis

    Of the 38 infants in Phase II, 2 parents did not consent to continue monitoring

    for 12 hours in the study. Data could not be recorded in 5 infants due to technical

    difficulties. The remaining 31 infants were monitored as per the protocol and included

    in the data analysis. Details of the infants included in the study are shown in Table

    7.1. 55% were boys and 45% were girls. Both groups were comparable in regards to

    birth weight and gestation.

    Table 7.1. Demographic characteristics of newborns in Phase I & II at TCH

    Site No & Gender Gestation

    in Weeks

    Birth Weight

    (Grams)

    TCH Phase I 6 Boys

    14 Girls

    38.7±1.1 2811±325

    TCH Phase II 22 Boys

    9 Girls

    38.4±1.1 2856.6±318

    Maternal details:

    All mothers were in the age group of 19-28 years. 7(13%) were uneducated,

    3(5%) had received primary school education only and the rest (80%) had received

    secondary school education. All belonged to class III-IV modified BG Prasad

    classification. [140]

    Mean (SD) duration of labor was 9.6(4.3) hours. The mothers were

    normotensive at admission and had mean (SD) Hb of 10.9(1.1)grams%. Majority

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    were second gravida (55%), 33% were primigravida and the rest were multi gravida

    mothers.

    Table 7.2 gives the details about mean duration of labor, Apgar score and

    mean time taken to obtain first data in the two studies at TCH.

    Table 7.2. Labor & delivery characteristics in phase I & II at TCH

    Study

    site

    Mean

    Duration

    of labor

    Mean

    Apgar

    Score

    1 min

    Mean

    Apgar

    score

    5 min

    Mean time

    from birth to

    first

    data(minutes)

    Mean time to

    clamp the

    cord

    (Seconds)

    TCH

    Phase I

    8.5±1.1

    (6-11)

    hours

    7±1.2 8.3±0.5 3.2±0.25* 24.8±22.5

    TCH

    Phase II

    7.9±1.8

    (4-10)

    hours

    8.2±0.9 9.2±0.8 2.4±0.3* 22.8±17.3

    * Difference statistically significant ( P=.02)

    There was no significant difference in duration of labor in mother and mean

    time to clamp the cord in two phases. Mean Apgar score in both groups were 7,8 and

    8,9 at 1 and 5 minutes respectively. The difference in time to acquire first data from

    time of birth was significant in the two phases.

    7.2. B. Analysis of oxygen saturation:

    Fig 7.7 shows a typical SpO2 recording in a baby in the delivery room. This

    was a term baby boy weighing 3100 grams who did not require resuscitation after

    birth. First SpO2 tracing was obtained at 95 seconds in this infant and total 7778

    data points for SpO2 were collected at an interval of 5 seconds over 11 hours time

    from birth. The values shown in graph are the SpO2 values at 30 seconds time interval

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    over first 30 minutes of life. The infant achieved SpO2 of 90% by 6 minutes and 95%

    by 7.5 minutes from birth.

    Fig. 7.7. Change in SpO2 over 15 minutes period from birth in a newborn at TCH

    Table 7.3 gives the median (IQR) oxygen saturation at intervals of one minute

    from birth to 15 minutes of age. The first median (IQR) oxygen saturation level which

    was recorded in 9 newborns by 2 minutes of age was 69%(68-79). At 5 minutes

    median SpO2 was 88%. A gradual rise in SpO2 is seen till it reaches a plateau of 96%

    from 12 minutes of life. Number of babies in whom SpO2 was recorded is also shown.

    50 55 60 65 70 75 80 85 90 95

    100

    0.0

    1.0

    2.0

    3.0

    4.0

    5.0

    6.0

    7.0

    8.0

    9.0

    10

    .0

    11

    .0

    12

    .0

    13

    .0

    14

    .0

    S

    p

    O

    2

    %

    Time from birth in minutes SpO2(%)

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    Table 7.3. Median (IQR) values of oxygen saturation (SpO2%) from one to

    fifteen minutes and one to twelve hours of birth.

    TFB

    (min)

    Median SpO2(IQR) TFB

    (hours)

    Median

    SpO2(IQR)

    2 69(68-79)N=9 1 98(95-100)N=48

    3 80(74-91)N=27 2 98(95-100)N=46

    4 82.5(76-90)N=34 3 97(95-99)N=49

    5 88(81-90)N=42 4 97(95-100)N=50

    6 89(83-92.5)N=43 5 96(94-98)N=46

    7 91(87-96)N=46 6 96(93-98)N=44

    8 92(87-97)N=45 7 95(93-98)N=48

    9 93(88-97)N=45 8 96(94-98)N=49

    10 94(88-97)N=45 9 96(94-97)N=47

    11 95(93-97)N=45 10 96(94-97)N=48

    12 96(91-98)N=45 11 96(94-97)N=47

    13 96.5(90-98)N=46 12 95(93-97)N=49

    14 96.5(92-99)N=46

    15 96(93-99)N=46

    Figure 7.8 shows the cumulative sequential changes in oxygen saturation in all

    51 babies studied. The median level of SpO2 of 90% and 95%saturation was attained

    at 6.5 minutes and at 11 minutes of life respectively.

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    Fig 7.8. Box and Whiskers graph showing change in SpO2 over first 15 minutes

    in 51 infants at TCH

    Box and Whiskers graph showing change in SpO2 over first 15 minutes in 51 infants.

    The median and IQR of oxygen saturation at intervals of one minute are shown. Box

    gives the interquartile range (25th

    to 75th

    centile) and the whiskers represent 1.5 IQR

    beyond each box. Median is represented by the horizontal line in the box.

    40

    50

    60

    70

    80

    90

    100

    1 2 3 4 5 6 7 8 9 10 11 12 13 14 15

    SpO

    2 %

    Time From Birth in Min

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    Difference in trends in SpO2 in two seasons:

    Fig 7.9 shows the trend in SpO2 change in phase I and phase II study at TCH.

    Infants from both groups achieved oxygen saturation of 95% by 11 minutes. The

    difference in SpO2 at 2 and 3 minutes though clinically significant it is not statistically

    significant due to small no. of readings.(N=3&9 at 2&3 min respectively in Phase I)

    Fig 7.9. Trends in SpO2 in infants delivered in phase I & II at TCH

    7.2. C. Color and Oxygenation

    At birth all babies had blue or pale palms and soles. Tongue and oral mucosa

    was pink at birth except in 2 infants but they did not require supplemental oxygen as

    per NRP 2006 protocol and all infants were centrally pink by 5 minutes.

    Fig7.10 shows sequential changes in the color of palms and soles over first 2

    hours in a newborn infant. This was full term normal vaginal delivery and baby did

    not need resuscitation. The color changed to pink gradually over next few minutes.

    Fig7.10.a & Fig 7.10.b shows color of palms and soles by 5 minutes of life.

    Oxygen saturation at this time was 89%. Both palms and soles were dusky.

    10

    20

    30

    40

    50

    60

    70

    80

    90

    100

    1 2 3 4 5 6 7 8 9 10 11 12 13 14 15

    S

    p

    O

    2

    %

    Time from birth in minutes

    SpO2 Phase II SpO2 Phase I

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    Fig 7.10.c & fig. 7.10.d color of palms and soles at 15 minutes of life when

    oxygen saturation was 100%. Note the change in color of palms but soles still have

    dusky hue.

    Fig 7.10.e & Fig 7.10.f Color of palms and soles at 2 hours of life.Both palms

    and soles were bright pink in color and oxygen saturation was > 95%. Soles were still

    cold to touch.

    Fig 7.10.b Blue soles at 5 minutes

    Fig 7.10.a Blue palms at 5 minutes

    Fig 7.10.d Blue soles at 15 minutes Fig 7.10.c Color of palms improved towards pink by 15 minutes

    Fig 7.10.e Pink palms at 2 hours

    Fig 7.10.f Pink soles at 2 hours

    Fig 7.10.f Pink soles at 2 hours

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    Infants with initial pale palms and soles developed dusky hue before turning

    pink and took comparatively longer time to become pink. During this phase the

    oxygen saturation changed from 96%to 97 %. (Difference in SpO2 is not statistically

    significant.P=.1) The readings showed skewed distribution. Median (IQR) time taken

    for palms to become pink from blue was 30 minutes (16.2-135 minutes, N=40)) but

    pale palms took significantly longer time 3.25hours (2.9-4.4,N=11)) to become pink.

    This was also associated with CRT > 4 seconds (discussed later Page no76). By 15

    minutes 19 (37.25%) infants had pink palms but pink soles were noted in only one

    baby (2%).

    Table 7.4 shows the sensitivity and specificity of pink color (combined data of

    blue/pale palms and soles to pink) & warmth of palms & soles in relation to SpO2

    ≥95% & abdominal temperature (Ta) ≥ 36.50C at specific time intervals from birth.

    The time intervals were determined based on the mean time at which the change in

    color and temperature was noted.

    Table 7.4. Sensitivity & specificity of color and touch to recognize normal oxygen

    saturation and body temperature from birth.

    Pink Palms Pink Soles Pink &

    Warm Palms

    Pink & warm

    Soles

    TFB

    Median(IQR)

    30(16.2-135)min 3.3(1.3-

    5.1)hours

    3.3(2.5-

    6)hours

    6.5(4-8)hours

    Sensitivity 77% 65% 70% 66%

    Specificity 14% 20% 36% 20%

    By one hour 41 infants (80%) had pink palms where as only 12 (23.5%)

    infants had pink soles. No significant differences were found in saturations when

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    palms became pink (96%) as compared to saturations when soles became pink (97%).

    16 (31%) infants had blue palms when SpO2 was less than 92 %.( Table 7.5).

    Soles always became pink later than the palms. Blue soles became pink earlier

    (median time 2.1 hours N=41) than soles that were pale at birth (median time 6 hours,

    N=10). But there was no statistically significant difference in SpO2. All babies took

    11 minutes to reach SpO2 of 95% but the palms and soles became pink only by

    3.3(1.3-5.1) hours. Thus there was a significant discordance between skin color and

    actual oxygen saturation. This is a clinically important observation.

    Table 7.5. Oxygen saturation and clinical assessment of color & warmth.

    SpO2 98%

    Palms pink & Warm (N=51) 3 12 16 20

    Soles Pink & warm (N =51) 1 18 12 20

    Palms remained blue and cold

    (max SpO2)(N=51)

    16 7 17 11

    7.2. D. Changes in heart rate

    The earliest recorded median (IQR) heart rate was 182 bpm (160-189). By 15

    minutes it gradually came down to 154bpm (145-169). Fig 7.11 is a box and whiskers

    showing change in heart rate over first 15 minutes of birth.

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    Fig. 7.11: Change in heart rate in 51 infants in first 15 minutes at TCH.

    Fig. 7.11. is a Box and Whiskers graph showing change in heart rate (bpm)

    over first 15 minutes in 51 infants. The median and IQR of heart rate at intervals of

    one minute are shown. Box gives the interquartile range (25th

    to 75th

    centile) and the

    whiskers represent 1.5 IQR beyond each box. Median is represented by the horizontal

    line in the box.

    All the values are shown in Table 7.6. It also gives the values of HR every

    hour from 1 to 12 hours of life .

    Table 7.6. Median heart rate in bpm from 2 to 15 minutes of life and 1 to 12

    hours of life

    TFB (minutes) HR bpm

    Median (IQR)

    TFB (Hours) HR bpm

    Median (IQR)

    2 182(160-189)N=9 1 136(128-142)N=48

    3 183(167-192)N=27 2 127(114-138)N=46

    4 179(150-190)N=34 3 118(111-123)N=49

    5 180(167-190)N=42 4 118(110-130)N=50

    6 175(163-186)N=43 5 118(109-125)N=46

    10

    60

    110

    160

    210

    1 2 3 4 5 6 7 8 9 10 11 12 13 14 15

    h

    e

    a

    r

    t

    R

    a

    t

    e

    Time from birth in minutes

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    7 176(159-184)N=46 6 119(108-128)N=44

    8 167(158-181)N=45 7 122(113-138)N=48

    9 166(154-181)N=45 8 123(112-134)N=49

    10 165(154-173)N=45 9 121(112-135)N=47

    11 163(150-173)N=45 10 124(116-136)N=48

    12 160(149-172)N=46 11 122(114-137)N=47

    13 156(144-171)N=46 12 125(116-132)N=49

    14 157(148-170)N=46

    15 154(145-169)N=46

    Heart rate came down even further to 118 bpm (111-123) by 3 hours of life. At

    12 hours the median heart rate recorded was 125 bpm (116-133).

    7.2. E. Trend in NIBP over 12 hours

    We ensured that the NIBP was recorded when baby was quiet after application

    of the cuff and during recording of the blood pressure as per the standard

    recommended protocol. This was difficult especially in the first fifteen minutes and at

    times we had to abandon recording the blood pressure. We recorded 351 NIBP

    readings in 51 babies. However we excluded 65 readings as they were out of the

    specified time or taken during excessive movements or crying. So we analyzed 289

    readings (83%) of which 172 readings were taken in first hour of life. The earliest

    NIBP reading recorded was by 4 minutes of age.

    For analysis the mean blood pressure readings during each 15 minutes interval

    in first hour of life, every 3 hours till 6 hours and then between 6-12 hours were

    calculated as shown in table 7.7.

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    Table 7.7. Mean±SD systolic, diastolic and mean blood pressure from 5 minutes

    to 12 hours after birth.

    TFB No of

    infants

    Systolic BP

    mmHg

    Diastolic

    BP mmHg

    Mean BP

    mmHg

    5-15 min 33 70.05±9 43.7±9 52.5±8

    15-30 min 49 68.21±8 41.4±7 50.4±7

    30-45 min 44 69.5±11 40.9±8 50.5±8

    45-60 min 46 69.9±8.5 41.2±7 50.1±7

    1-3 hours 41 68.0±6 41.0±7 50.8±5

    3-6 hours 34 65.2±7* 39.2±7* 48.1±6*

    6-12 hour 35 69.1±8 43.76±7 52.05±9

    *Statistically significant difference in blood pressure compared to all previous and

    later readings.(P

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    from 1-6 hours of birth. The difference was statistically significant when compared

    with previous readings till 3 hours. A gradual rising trend in the blood pressure was

    seen between 6-12 hours interval.

    7.2. F. Capillary Refill Time

    Capillary refill time was more prolonged in soles than palms at 5 minutes.

    (Maximum 8 seconds on soles, 5 seconds on palms, and 3 seconds on sternum) .It

    gradually decreased in all areas especially in first hour as shown in table 7.8.

    Table 7.8. Mean CRT±SD from 5 minutes to 12 hours of birth on palms and soles

    Time from birth 5min 15min 30min 1hr 12 hours

    CRT palm (sec) 4.5±.7 3.7±0.6 3.3±0.45 3.16±0.37 3±0.22

    CRT sole(sec) 5.8±0.9 5.1±1.2 4.8±1.1 4.1±1.01 3.3 ±0.46

    CRT sternum (sec) 3±0.52 2±0.50 2±0.37 2±022 2±022

    Mean CRT was 3.3±.45 seconds in palms when they became pink. We

    observed that the CRT improved first followed by change in color to bright pink both

    in palms and soles.

    We compared the mean CRT with systolic blood pressure to study their

    correlation.

    Table 7.9 gives mean CRT on soles, mean systolic blood pressure, and

    sensitivity and specificity of CRT on soles to mean systolic blood pressure in every 15

    minutes interval from birth to 1 hour of life. There was no major change in mean

    systolic pressure from 1 to 60 minutes of life (not statistically significant) but the

    difference in CRT from 5 minutes to 1 hour was statistically significant.

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    Table 7.9. CRT, mean ±SD systolic blood pressure at specific time intervals from

    birth till 1 hour, Sensitivity & specificity of CRT to mean systolic blood pressure

    Time from

    birth

    CRT Sole

    (min)

    Mean Systolic BP

    with 95% CI

    (mmHg)

    Sensitivity Specificity

    5-15 min

    N=34

    5.8±0.9 70±9.2

    67.2-73

    69% 50%

    15-30 min

    N=44

    5.1±1.1 68.2±8.2

    66.3-70.3

    65% 31%

    30-45 min

    N=48

    4.3±1.1 69.9±8.4

    67.3-72.4

    77% 35%

    45-60 min

    N=49

    3.5±0.6 69.9±8.5

    67.4-72.3

    64% 41%

    CRT remained prolonged for longer time over palms & soles when palms &

    soles were cold.

    The order of physiologic transition that we noted was: improved oxygen

    saturation (11minutes), CRT shortening on palm (15min-1 hour), pink color (30min-

    3.3hours) & warmth (3.3-6.5hours).They progressed in cephalo caudal manner: hands

    to feet.

    7.2. G Abdominal and foot temperature in first 12 hours

    Phase I of our study was conducted from July to October 2008. This was rainy

    season and Belgaum had the typical cold (environmental temperature 18- 270C) and

    humid (50-90%) weather during the study period. Phase II was conducted from

    January to March 2009 which was spring time in this part of Karnataka.

    Environmental temperature during this period varied from 22-280C and humidity was

    in the range of 35-45%.

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    Table 7.10 gives the mean room temperature(0C) and humidity(%) in the DR

    and PNW of KLEUH during the study period. The temperature in the DR was 0.80C

    lower than in PNW during both seasons and the temperature in DR and PNW was

    higher by a minimum of 1.50C during the spring season compared to that of rainy

    season. Humidity in rainy season was 30% higher than during spring season.

    Table 7.10. Room temperature and humidity in Rainy (Phase I) &

    spring (Phase II) seasons in DR & PNW at TCH

    Location DR PNW

    Season Rainy Spring Rainy Spring

    Room Temperature0C

    Mean±SD

    24.5 ±1.3* 26.18±1.1 * 25.36± 1.14 * 26.9±1.3 *

    Humidity Mean±SD 79.3±8 %* 47.2± 6%6 * 81±9% * 50± 8 %*

    *The difference in temperature and humidity in DR and PNW was significant

    during the two phases.

    Thermal Adaptation in Rainy & Spring Season:

    Temperature trends of Phase I and Phase II are shown in Figure 7.13. The

    trends in Ta and Tf in different seasons are plotted against time from birth to 12 hours

    of age. Both the groups started at similar Ta and Tf in the delivery room. The mean

    Ta in both groups continued to be similar all through the study period. The mean time

    taken to reach temperature (Ta) of 36.50C by 50% infants was 3.9 hours. A significant

    difference was seen in mean Tf between the two groups in the delivery room and in

    the postnatal ward (P=0.02, P=0 respectively).

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    Fig 7.13. Trends in abdominal(Ta) and foot (Tf) skin temperature from 5

    minutes to 12 hours of birth in rainy(phase I ) and spring (phase II) season.

    Difference in Trends by Season:

    Rainy season: in the delivery room the mean (SD) Ta was 34.60C (0.69) at 5 minutes

    and reached maximum of 35.90C (0.6) at 2 hours of age, but the mean (SD)Tf dropped

    precipitously to 30.30C(1.5) by 2.5 hours. Mean Td increased from 3.5(0.8) at 15

    minutes to 5.48(0.9) before transfer of the infant to the PNW. During transfer of the

    infant to the PNW Tf dropped further reaching a mean Tf of 30.20C (1.3) and Td of

    5.30C (1.4) at 3 hours of age. In the PNW the mean Ta &Tf dropped further down to

    35.50C (0.8) and 29.7

    0C (1.33) by 4.5 hours. Ta gradually increased to 36.02(0.4) at 8

    hours of age and rose further to 36.40C (0.48) by 12 hours of age. Mean Tf increased

    to 32.90C (2.97) by 12 hours. Mean Td also increased to 5.94

    0C (1.39) at 4.5 hours of

    age and decreased gradually to 3.540C (1.56) by 12 hours.

    Spring Season: in the delivery room the maximum mean (SD) Ta was 35.80C (0.51)

    by 1 hour of age. The lowest recorded Ta and Tf was 35.270C (1.8) and 30.39

    0C(1.28) respectively with maximum mean (SD) Td of 5.2

    0C(1.1) at 1.5 hours. During

    28.0

    29.0

    30.0

    31.0

    32.0

    33.0

    34.0

    35.0

    36.0

    37.0

    38.0

    0.1

    0.5

    0.8

    1.0

    1.5

    2.0

    3.0

    4.0

    5.0

    6.0

    7.0

    8.0

    9.0

    10

    .0

    11

    .0

    12

    .0

    T

    e

    m

    p

    0

    C

    Time from birth in hours

    Ta (phase I)

    Tf ( phase I)

    Ta (phase II)

    Tf (phase II)

  • SECTION-II 7 : Studies at KLEUH

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    transfer Tf dropped further to 30.330C (0.12) and Td increased to 5.3

    0C (1.2) but Ta

    was maintained at 35.60C (0.08) during this period. In the PNW, the mean (SD) Tf

    dropped to the minimum of 30.130C (0.14) by 2.5 hours and then showed a consistent

    rise to maximum of 33.50C (1.9) by 12 hours of life. Ta showed a rising trend to reach

    maximum of 36.50C (1.9) by 12 hours of life.

    Table 7.11 gives mean ±SD Ta and Tf in DR and PNW in two seasons. The

    difference in abdominal temperature though small, was statistically significant in two

    seasons. The foot temperature was significantly higher in DR and PNW in spring

    season than in rainy season.

    Table 7.11. Mean ±SD Ta & Tf in DR & PNW in Rainy and spring season

    Ta Mean(SD) Tf Mean (SD)

    DR PNW DR PNW

    Rainy season(I) 35.6±0.26 35.9±0.24 30.6±0.43 31.3±1.07

    Spring season(II) 35.6±0.21 36.1±0.19 31.2±0.58 32.6±0.76

    P(Rainy vs. spring) NS 0.0002 .002 0

    Selected data points in 2 groups at 0.08 hours (5 minutes), 2, 6 and 12 hours

    are shown in Table 7.12. Ta, Tf is high and Td is low at all points in infants from

    Phase II but the difference in Ta, Tf and Td between two groups is statistically

    significant at 6 hours from birth(P ≤.04). At 12 hours the difference is marginally

    significant for Tf (P

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    Table 7.12. Mean ±SD Ta & Tf at specific time from birth in phase I & II

    Time

    from

    Birth

    (hours)

    Ta (I)

    Mean± SD

    Ta(II)

    Mean± SD

    Tf(I)

    Mean ± SD

    Tf(II)

    Mean± SD

    Td( I)

    Mean± SD

    Td(II)

    Mean± SD

    0.08 34.62±0.69 34.65±0.53 32.39±0.94 32.55±0.95 2.24±1.2 2.10±1.3

    2.00 35.9±0.63 35.48±0.9 30.53±1.39 30.40±1.44 5.34±1.4 5.08±1.12

    6 35.63±0.63* 35.95±0.46* 30.38±1.42* 32.51±1.5* 5.33±1.1* 3.44±1.5*

    12 36.36±0.48 36.48±0.31 32.21±2.9 33.51±1.97 3.54±1.56 2.96±1.7

    *P ≤.04 (SD) Standard Deviation

    Area Between The curves Ta and Tf:

    We assumed that the area between Ta and Tf over a unit time serves as a

    proxy to metabolic stress in the baby. To estimate this stress we calculated the area

    between mean Ta and Tf from birth to 12 hours age using the trapezoidal rule.

    Fig 7.13 shows the area between Ta and Tf at three different locations. Table 7.13

    shows the difference in Ta and Tf at each location of the infant from birth to first 12

    hours of life and the metabolic stress experienced by these infants in these locations in

    both seasons. The area between the curves Ta and Tf at each of the locations is

    shown. The area between the curves per hour was the highest during transfer of the

    infant from DR to PNW when Td widened further in both the groups and it was least

    in the PNW when a gradual increase both in Ta and Tf was seen. The difference in Td

    between both groups was statistically significant at all three locations. The stress

    experienced during rainy season was also higher in all three locations but the

    maximum total stress was observed in the PNW (75%) in both the groups.

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    Table 7.13. Difference between Ta and Tf (Td) and Area between Ta and Tf

    Location

    (Duration in

    hours)

    Td 0C Mean±SD Metabolic stress :Area between

    Ta and Tf

    Phase I Phase II Phase I Phase II

    DR(2.5) 5± 0.72* 4.4± 0.72* 48428.47

    (23 %) 17295/hr

    26613(16 %)

    15207.3/hr

    TRANSFER(0.5) 5.39± 0.09* 5.27± 0.18* 14622.26 (6%)

    29244/hr

    14196 (8.6%)

    28392/hr

    PNW(8.5) 4.39± 1.03* 3.75± 0.87* 141041.92 (70%)

    16593/hr

    124037(75%)

    12403.3/hr

    *P≤.02.

    Fig 7.14 gives AUC (0C.min) between Ta & Tf in Phase I at three different

    locations of infants after birth till 12 hours. Shaded area represents the metabolic

    stress experienced by the infants. T stands for transport of infants from DR to PNW.

    Fig 7.14. AUC between Ta and Tf in phase I