Effect of a partially hydrolyzed whey infant formula at weaning on risk of allergic disease in high...
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Transcript of Effect of a partially hydrolyzed whey infant formula at weaning on risk of allergic disease in high...
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Effect of a partially hydrolyzed whey infant formula at weaning on risk of allergic disease in high-risk children:A randomized controlled trial
(J Allergy Clin Immunol 2011;128:360-5.)
Sadudee Boonmee,MD
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• Partially hydrolyzated whey formulas (pHWFs) have widely recommended to prevent the development of allergic disease in early childhood.
• Inexpensive formulas• Contain smaller , less immunogenic milk
protein – derived peptides reduced allergenicity
J Allergy Clin Immunol 2011;128:360-5
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• Cochrane review found “ significant reduction in infant allergy compared pHWF with CMF “
• Publication Bias ???• Asymmetry in funnel plots• Small studies report stronger protective effectof pHWF than larger studies
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• GINI studies reports that pHWF reduced the incidence of eczema in earlychild hood in a per protocal analysis but fails in ITT analysis
• Aim To determine the use of pHWF reduced the incidence of allergic manifestation (eczema,and food reaction ) up to age 2 years of age
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Methods Inclusion criteria and Exclusion criteria
Between 1990-1994 at Mercy Maternity Hospital, Melbourne, Australia Mothers were invite to participate in a study of modification of infant diet on the risk of infant allery. Enrollment : unborn child had a first – degree relative with history of eczema, asthma, allergic rhinitis, or food allergy
J Allergy Clin Immunol 2011;128:360-5
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Intervention
Soy - based formular (ProSobee ;Mead Johnson nutrition) 2 intervention
formulas
pHWFs ( NAN HA; Nestle)
CMF (NAN ; Nestle) Control
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• Mother were encoraged to initiate and maintain breast-feeding for at least 6 months.
• Study formula were introduced only cessation or partial cessation or as breast milk substitute if breast – feeding was not intended .
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Study design• Single blind Randomized control trial
(paticipant)• Idependent statistician random codes
allocation.• Code avialable to research staff • Staff were blind to allocated codes and group
allocated.• Mother & Baby pair allocated to the next
sequence number as enrolled J Allergy Clin Immunol 2011;128:360-5
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Study design
• Cans of each formula were labeled • Parent informed of assigned formula only
child’s second birthday.
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Study design
Rice cereal,pureed apple and pear from 4 months of age.
Vegetables and other fruit from 6 months of age.
Meat from 9 months of age.
Dairy products, egg, fish, peanut, and nuts avoided until 12 months of age
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Outcome
• Primary outcome- Any allergic manifestation at first 2 years of life
• Secondary outcome - Sensitization to cow’s milk and any allergen- Childhood asthma, rhinitis, and eczema at ages 6 and 7 years
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Outcome
SPT performed at 6, 12, and 24 months by research nurses with standard technique.
Allergen extracts used were cow’s milk, egg white, peanut, HDM, rye grass, and cat dander
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J Allergy Clin Immunol 2011;128:360-5
• 18 telephone interview ( every 4 weeks until 64 weeks, then at 78 and 104 weeks)
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Statistic methods
Primary analysis : ITT and compared risk of any allergic manifestation between the allocated formula groups by using simple proportions and χ 2 [ Odds ratio with 95% CI ]
Secondary analysis : outcome of sensitization to cow’s milk and any allergen and childhood asthma, rhinitis, and eczema at ages 6 and 7 years
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Results
J Allergy Clin Immunol 2011;128:360-5
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Baseline
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Result
• 50% of infant received some of allocated formula by 4 month of age
• 16.5% never received allocated formula because of either continue BF or using nonallocated formula.
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No differences in rates of exposure to allocated formula between groups
J Allergy Clin Immunol 2011;128:360-5
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Result
• Majority of mothers fully adhered to study formula feeding protocol during first 6 months of life ( CMF 91.2%, pHWF 86.9%, Soy 87.4% )
J Allergy Clin Immunol 2011;128:360-5
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Outcome
J Allergy Clin Immunol 2011;128:360-5
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Secondary outcome in first 2 years
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Outcome
J Allergy Clin Immunol 2011;128:360-5
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Adjusted analysis
J Allergy Clin Immunol 2011;128:360-5
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Interactions with family history of eczema
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Per – protocal analysis
• None produced different findings from ITT analysis.
• Limiting analysis to children who compliant with the study feeding protocol did not alter the study conclusions (primary outcome OR, 1.20; 95% CI, 0.75-1.93, for pHWF
• Excluding infants exclusively breast-fed for more than 4 months did not alter the results OR, 1.22; 95% CI, 0.72-2.04, for pHWF
J Allergy Clin Immunol 2011;128:360-5
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Per – protocal analysis
• Infants who had consumed some of the allocated formula OR, 1.16; 95% CI, 0.66-2.02
• consumed the allocated formula for at least 2 weeks during the first 4 months of life OR, 1.10; 95% CI, 0.59-2.04
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Discussion
• This randomized controlled trial failed to show any beneficial effect of the pHWF for the prevention of any allergic disease outcome up to 7 years of age in high-risk children compared with a conventional cow’s milk–based formula.
J Allergy Clin Immunol 2011;128:360-5
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Discussion
• An ITT analysis GINI study, also failedto demonstrate benefit of pHWF over conventional formulaFor allergic manifestations and eczema up to 12 mo, and childhood eczema, asthma, or allergic rhinitis at age 6 and 7 years
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J allergy Clin Immunol 2008;121:1442-7
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Conclusion
• There no evidence that introducing pHWF at the cessation of breast feeding reduced risk of allergic manifestation in high risk infant
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