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Effect of a partially hydrolyzed whey infant formula at weaning on risk of allergic disease in high-risk children: A rando...
<ul><li>Partially hydrolyzated whey formulas (pHWFs) have widely recommended to prevent the development of allergic diseas...
<ul><li>Cochrane review found “ significant reduction in infant allergy compared pHWF with CMF “ </li></ul><ul><li>Publica...
<ul><li>GINI studies reports that pHWF reduced the incidence of eczema in earlychild hood in a per protocal analysis but f...
Methods  <ul><li>Inclusion criteria and Exclusion criteria </li></ul><ul><ul><li>Between 1990-1994 at Mercy Maternity Hosp...
Intervention <ul><ul><li>Soy - based formular (ProSobee ; </li></ul></ul><ul><ul><li>Mead Johnson nutrition)  2  intervent...
<ul><li>Mother were encoraged to initiate and maintain breast-feeding for at least 6 months. </li></ul><ul><li>Study formu...
Study design <ul><li>Single blind Randomized control trial (paticipant) </li></ul><ul><li>Idependent statistician random c...
Study design <ul><li>Cans of each formula were labeled  </li></ul><ul><li>Parent informed of assigned formula only child’s...
Study design <ul><ul><li>Rice cereal,pureed apple and pear  from 4 months of age. </li></ul></ul><ul><ul><li>Vegetables an...
Outcome <ul><li>Primary outcome </li></ul><ul><li>- Any allergic manifestation at first 2 years of life </li></ul><ul><ul>...
Outcome <ul><ul><ul><li>SPT performed at 6, 12, and 24 months  by research nurses with standard technique. </li></ul></ul>...
<ul><li>18 telephone interview ( every 4 weeks until 64 weeks, then at 78 and 104 weeks) </li></ul>J Allergy Clin Immunol ...
 
Statistic methods <ul><li>Primary analysis  :  ITT and compared risk of any allergic manifestation between the allocated f...
Results J Allergy Clin Immunol 2011;128:360-5
Baseline
Result <ul><li>50% of infant received some of allocated formula by 4 month of age </li></ul><ul><li>16.5%  never received ...
No  differences in rates of exposure to allocated formula between groups J Allergy Clin Immunol 2011;128:360-5
Result <ul><li>Majority of mothers fully adhered to study formula feeding protocol  during first 6 months of life  ( CMF 9...
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 <ul><li>None produced different findings from ITT analysis. </li></ul><ul><li>Limiting analysis to...
Per – protocal analysis <ul><li>Infants who had  consumed some of the allocated formula  </li></ul><ul><li>   OR, 1.16; 9...
Discussion  <ul><li>This randomized controlled trial  failed to show any beneficial  effect of the pHWF  for the  preventi...
Discussion  <ul><li>An  ITT analysis GINI study, also failed </li></ul><ul><li>to demonstrate benefit of pHWF over convent...
J allergy Clin Immunol 2008;121:1442-7
 
 
 
 
 
Conclusion <ul><li>There no evidence that introducing pHWF at the cessation of breast feeding reduced risk of allergic man...
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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

Presented by Sadudee Boonmee, MD.

Published in: Health & Medicine
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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

  1. 1. 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
  2. 2. <ul><li>Partially hydrolyzated whey formulas (pHWFs) have widely recommended to prevent the development of allergic disease in early childhood. </li></ul><ul><li>Inexpensive formulas </li></ul><ul><li>Contain smaller , less immunogenic milk protein – derived peptides  reduced allergenicity </li></ul>J Allergy Clin Immunol 2011;128:360-5
  3. 3. <ul><li>Cochrane review found “ significant reduction in infant allergy compared pHWF with CMF “ </li></ul><ul><li>Publication Bias ??? </li></ul><ul><li>Asymmetry in funnel plots </li></ul><ul><li>Small studies report </li></ul><ul><li>stronger protective effect </li></ul><ul><li>of pHWF than larger studies </li></ul>
  4. 4. <ul><li>GINI studies reports that pHWF reduced the incidence of eczema in earlychild hood in a per protocal analysis but fails in ITT analysis </li></ul><ul><li>Aim </li></ul><ul><li>To determine the use of pHWF reduced the incidence of allergic manifestation (eczema,and food reaction ) up to age 2 years of age </li></ul>
  5. 5. Methods <ul><li>Inclusion criteria and Exclusion criteria </li></ul><ul><ul><li>Between 1990-1994 at Mercy Maternity Hospital, Melbourne, Australia </li></ul></ul><ul><ul><li>Mothers were invite to participate in a study of modification of infant diet on the risk of infant allery. </li></ul></ul><ul><ul><li>Enrollment : unborn child had a first – degree relative with history of eczema, asthma, allergic rhinitis, or food allergy </li></ul></ul>J Allergy Clin Immunol 2011;128:360-5
  6. 6. Intervention <ul><ul><li>Soy - based formular (ProSobee ; </li></ul></ul><ul><ul><li>Mead Johnson nutrition) 2 intervention </li></ul></ul><ul><ul><li>formulas </li></ul></ul><ul><ul><li>pHWFs ( NAN HA; Nestle) </li></ul></ul><ul><ul><li>CMF (NAN ; Nestle) Control </li></ul></ul>J Allergy Clin Immunol 2011;128:360-5
  7. 7. <ul><li>Mother were encoraged to initiate and maintain breast-feeding for at least 6 months. </li></ul><ul><li>Study formula were introduced only cessation or partial cessation or as breast milk substitute if breast – feeding was not intended . </li></ul>J Allergy Clin Immunol 2011;128:360-5
  8. 8. Study design <ul><li>Single blind Randomized control trial (paticipant) </li></ul><ul><li>Idependent statistician random codes allocation. </li></ul><ul><li>Code avialable to research staff </li></ul><ul><li>Staff were blind to allocated codes and group allocated. </li></ul><ul><li>Mother & Baby pair allocated to the next sequence number as enrolled </li></ul>J Allergy Clin Immunol 2011;128:360-5
  9. 9. Study design <ul><li>Cans of each formula were labeled </li></ul><ul><li>Parent informed of assigned formula only child’s second birthday. </li></ul>J Allergy Clin Immunol 2011;128:360-5
  10. 10. Study design <ul><ul><li>Rice cereal,pureed apple and pear from 4 months of age. </li></ul></ul><ul><ul><li>Vegetables and other fruit from 6 months of age. </li></ul></ul><ul><ul><li>Meat from 9 months of age. </li></ul></ul><ul><ul><li>Dairy products, egg, fish, peanut, and nuts avoided until 12 months of age </li></ul></ul>J Allergy Clin Immunol 2011;128:360-5
  11. 11. Outcome <ul><li>Primary outcome </li></ul><ul><li>- Any allergic manifestation at first 2 years of life </li></ul><ul><ul><ul><li>Secondary outcome </li></ul></ul></ul><ul><ul><ul><li>- Sensitization to cow’s milk and any allergen </li></ul></ul></ul><ul><ul><ul><li>- Childhood asthma, rhinitis, and eczema at ages 6 and 7 years </li></ul></ul></ul>
  12. 12. Outcome <ul><ul><ul><li>SPT performed at 6, 12, and 24 months by research nurses with standard technique. </li></ul></ul></ul><ul><ul><ul><li>Allergen extracts used were cow’s milk, egg white, peanut, HDM, rye grass, and cat dander </li></ul></ul></ul>J Allergy Clin Immunol 2011;128:360-5
  13. 13. <ul><li>18 telephone interview ( every 4 weeks until 64 weeks, then at 78 and 104 weeks) </li></ul>J Allergy Clin Immunol 2011;128:360-5
  14. 15. Statistic methods <ul><li>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 ] </li></ul><ul><ul><ul><li>Secondary analysis : outcome of sensitization to cow’s milk and any allergen and childhood asthma, rhinitis, and eczema at ages 6 and 7 years </li></ul></ul></ul>J Allergy Clin Immunol 2011;128:360-5
  15. 16. Results J Allergy Clin Immunol 2011;128:360-5
  16. 17. Baseline
  17. 18. Result <ul><li>50% of infant received some of allocated formula by 4 month of age </li></ul><ul><li>16.5% never received allocated formula because of either continue BF or using nonallocated formula. </li></ul>J Allergy Clin Immunol 2011;128:360-5
  18. 19. No differences in rates of exposure to allocated formula between groups J Allergy Clin Immunol 2011;128:360-5
  19. 20. Result <ul><li>Majority of mothers fully adhered to study formula feeding protocol during first 6 months of life ( CMF 91.2%, pHWF 86.9%, </li></ul><ul><li>Soy 87.4% ) </li></ul>J Allergy Clin Immunol 2011;128:360-5
  20. 21. Outcome J Allergy Clin Immunol 2011;128:360-5
  21. 22. Secondary outcome in first 2 years J Allergy Clin Immunol 2011;128:360-5
  22. 23. Outcome J Allergy Clin Immunol 2011;128:360-5
  23. 24. Adjusted analysis J Allergy Clin Immunol 2011;128:360-5
  24. 25. Interactions with family history of eczema J Allergy Clin Immunol 2011;128:360-5
  25. 26. Per – protocal analysis <ul><li>None produced different findings from ITT analysis. </li></ul><ul><li>Limiting analysis to children who compliant with the study feeding protocol did not alter the study conclusions (primary outcome </li></ul><ul><li> OR, 1.20; 95% CI, 0.75-1.93, for pHWF </li></ul><ul><li>Excluding infants exclusively breast-fed for more than 4 months did not alter the results </li></ul><ul><li> OR, 1.22; 95% CI, 0.72-2.04, for pHWF </li></ul>J Allergy Clin Immunol 2011;128:360-5
  26. 27. Per – protocal analysis <ul><li>Infants who had consumed some of the allocated formula </li></ul><ul><li> OR, 1.16; 95% CI, 0.66-2.02 </li></ul><ul><li>consumed the allocated formula for at least 2 weeks during the first 4 months of life </li></ul><ul><li> OR, 1.10; 95% CI, 0.59-2.04 </li></ul>
  27. 28. Discussion <ul><li>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. </li></ul>J Allergy Clin Immunol 2011;128:360-5
  28. 29. Discussion <ul><li>An ITT analysis GINI study, also failed </li></ul><ul><li>to demonstrate benefit of pHWF over conventional formula </li></ul><ul><li>For allergic manifestations and eczema up to 12 mo, and childhood eczema, asthma, or allergic rhinitis at age 6 and 7 years </li></ul>
  29. 30. J allergy Clin Immunol 2008;121:1442-7
  30. 36. Conclusion <ul><li>There no evidence that introducing pHWF at the cessation of breast feeding reduced risk of allergic manifestation in high risk infant </li></ul>
  31. 37. Comment

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