Abstract
BackgroundThe 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/DesignThe study is a prospective, randomized, single-blind and controlled clinical trial. Preterm children with a gestational age less than 34 weeks meeting the inclusion criteria who cannot be breastfed will be included. To demonstrate the application effect of extensively hydrolyzed milk protein formula on the target population, preterm children will be randomized 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.DiscussionThis will be the first randomized 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 registrationThis study was registered with the Chinese Clinical Trial Registry (http://www.chictr.org.cn/) with number ChiCTR-IOR-14005696, on December 22, 2014.
Highlights
Introduction to the formulaeThe two kinds of formula for feeding during the neonatal intensive care unit (NICU) stay and the formula for feeding after discharge from the NICU are all Dumex, a brand of French Danone-Nutricia for early life nutrition
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 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
Extensively hydrolyzed milk protein formula can accelerate gastric emptying and gastrointestinal transit time, and promote gastrointestinal hormone secretion, and these mechanisms are conducive for the gastrointestinal tolerability of preterm children, thereby lowering the incidence of gastroesophageal reflux and feeding intolerance in preterm children, achieving full enteral nutrition as soon as possible and reducing the time of parenteral nutrition
Summary
Introduction to the formulaeThe two kinds of formula for feeding during the NICU stay and the formula for feeding after discharge from the NICU are all Dumex, a brand of French Danone-Nutricia for early life nutrition. The gestational age of all preterm children when discharged from the NICU is all ≥34 weeks, and formula suitable for 0 to 6-month-old infants is uniformly chosen for them after discharge. From 2000 to 2008, preterm children led to 14–15 % of deaths of children younger than 5 years old in China [7]. According to the above data, we find that in all medical problems of newborns, the improvement of the survival rate and quality of life of preterm children is the target that the world focuses on tackling
Sign-in/Register to view highlights & summary Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
