We found no evidence to support short-term or prolonged feeding with a hydrolysed formula compared with exclusive breast feeding for prevention of allergic disease .
Very low- quality evidence indicates that short-term use of an EHF compared with a CMF may prevent infant CMA .
Further trials are recommended before implementation of this practice .We found no evidence to support prolonged feeding with a hydrolysed formula compared with a CMF for prevention of allergic disease in infants unable to be exclusively breast fed
BACKGROUND Infant formulas containing hydrolysed proteins have been widely advocated for preventing allergic disease in infants , in place of st and ard cow 's milk formula ( CMF ) .
However , it is unclear whether the clinical trial evidence supports this .
OBJECTIVES To compare effects on allergic disease when infants are fed a hydrolysed formula versus CMF or human breast milk .
If hydrolysed formulas are effective , to determine what type of hydrolysed formula is most effective , including extensively or partially hydrolysed formula ( EHF/PHF ) .
To determine whether infants at low or high risk of allergic disease , and whether infants receiving early short-term ( first few days after birth ) or prolonged formula feeding benefit from hydrolysed formulas .
Application effect of extensively hydrolyzed milk protein formula and follow-up in preterm children with a gestational age of less than 34 weeks: study protocol for a randomized controlled trial
Background The average incidence of preterm birth in the world is up to 11.1 % , and deaths of preterm children account for more than 50 % of neonatal deaths . Gastrointestinal function of preterm children with a gestational age less than 34 weeks is immaturely developed . For preterm children who can only be fed with formula due to their mothers ’ sickness , choosing a suitable formula can not only meet the high nutritional needs of preterm children , but also solve their low gastrointestinal tolerability , and is thus very important . Methods / Design The study is a prospect i ve , r and omized , single-blind and controlled clinical trial . Preterm children with a gestational age less than 34 weeks meeting the inclusion criteria who can not be breastfed will be included . To demonstrate the application effect of extensively hydrolyzed milk protein formula on the target population , preterm children will be r and omized into two groups , 185 subjects in each group . The observation group will be fed with extensively hydrolyzed milk protein ( 100 % whey protein ) formula , while the control group will be fed with preterm children ’s formula until the children are discharged from the neonatal intensive care unit ( NICU ) . All the formula involved in this study will be from Dumex . After discharge , both groups will be uniformly fed with formula for 0 to 6-month-old infants . For statistical analysis , a chi-square test and Student ’s t test will be applied using SAS 9.4 . Discussion This will be the first r and omized controlled clinical study with long-term observation of the growth and development of preterm children during the NICU stay and at 3-month follow-up after discharge from the NICU . Results from this study will be used to determine whether the extensively hydrolyzed formula is more suitable for the low gastrointestinal tolerability of preterm children , and also whether feeding preterm children who are fed with such formula during the NICU stay with ordinary infant formula after discharge from the NICU would affect the normal growth and development of preterm children in the early stage of their lives . Trial registration This study was registered with the Chinese Clinical Trial Registry ( http://www.chictr.org.cn/ ) with number ChiCTR-IOR-14005696 , on December 22 , 2014
We found no evidence to support short-term or prolonged feeding with a hydrolysed formula compared with exclusive breast feeding for prevention of allergic disease .
Very low- quality evidence indicates that short-term use of an EHF compared with a CMF may prevent infant CMA .
Further trials are recommended before implementation of this practice .We found no evidence to support prolonged feeding with a hydrolysed formula compared with a CMF for prevention of allergic disease in infants unable to be exclusively breast fed
BACKGROUND Infant formulas containing hydrolysed proteins have been widely advocated for preventing allergic disease in infants , in place of st and ard cow 's milk formula ( CMF ) .
However , it is unclear whether the clinical trial evidence supports this .
OBJECTIVES To compare effects on allergic disease when infants are fed a hydrolysed formula versus CMF or human breast milk .
If hydrolysed formulas are effective , to determine what type of hydrolysed formula is most effective , including extensively or partially hydrolysed formula ( EHF/PHF ) .
To determine whether infants at low or high risk of allergic disease , and whether infants receiving early short-term ( first few days after birth ) or prolonged formula feeding benefit from hydrolysed formulas .