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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
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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

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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

Effect of a partially hydrolyzed whey infant formula at weaning on risk of allergic disease in high risk children a randomized controlled trial

Presented by Sadudee Boonmee, MD.

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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 Effect of a partially hydrolyzed whey infant formula at weaning on risk of allergic disease in high risk children a randomized controlled trial Presentation Transcript

    • 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
      • 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
      • Cochrane review found “ significant reduction in infant allergy compared pHWF with CMF “
      • Publication Bias ???
      • Asymmetry in funnel plots
      • Small studies report
      • stronger protective effect
      • of pHWF than larger studies
      • 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
    • 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
    • Intervention
        • Soy - based formular (ProSobee ;
        • Mead Johnson nutrition) 2 intervention
        • formulas
        • pHWFs ( NAN HA; Nestle)
        • CMF (NAN ; Nestle) Control
      J Allergy Clin Immunol 2011;128:360-5
      • 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 .
      J Allergy Clin Immunol 2011;128:360-5
    • 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
    • Study design
      • Cans of each formula were labeled
      • Parent informed of assigned formula only child’s second birthday.
      J Allergy Clin Immunol 2011;128:360-5
    • 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
      J Allergy Clin Immunol 2011;128:360-5
    • 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
    • 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
      J Allergy Clin Immunol 2011;128:360-5
      • 18 telephone interview ( every 4 weeks until 64 weeks, then at 78 and 104 weeks)
      J Allergy Clin Immunol 2011;128:360-5
    •  
    • 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
      J Allergy Clin Immunol 2011;128:360-5
    • Results J Allergy Clin Immunol 2011;128:360-5
    • Baseline
    • 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.
      J Allergy Clin Immunol 2011;128:360-5
    • No differences in rates of exposure to allocated formula between groups J Allergy Clin Immunol 2011;128:360-5
    • 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
    • Outcome J Allergy Clin Immunol 2011;128:360-5
    • Secondary outcome in first 2 years J Allergy Clin Immunol 2011;128:360-5
    • Outcome J Allergy Clin Immunol 2011;128:360-5
    • Adjusted analysis J Allergy Clin Immunol 2011;128:360-5
    • Interactions with family history of eczema J Allergy Clin Immunol 2011;128:360-5
    • 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
    • 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
    • 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
    • Discussion
      • An ITT analysis GINI study, also failed
      • to demonstrate benefit of pHWF over conventional formula
      • For allergic manifestations and eczema up to 12 mo, and childhood eczema, asthma, or allergic rhinitis at age 6 and 7 years
    • 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
    • Comment