Effects of an Exclusive Human Milk Diet on Enteral Feeding Outcomes of Neonates With Congenital Gastrointestinal Disorders
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Emory University
- Enrollment
- 151
- Locations
- 1
- Primary Endpoint
- Time to full enteral feeding
Study Overview
Brief Summary
This study aims to identify whether an exclusive human milk diet (EHMD) would improve outcomes in neonates with congenital gastrointestinal disorders (CGD) and by facilitating an earlier transition off of parenteral nutrition (PN).
Detailed Description
Infants born with congenital gastrointestinal disorders (CGD) can be very challenging to treat. The CGD require surgery shortly after birth to correct the problems and recovery can take a long time.
During the period of time the infant's intestines are sick or don't work properly, they rely on parenteral nutrition (IV fluids containing carbohydrates, proteins and fats) to meet their nutritional needs. Being on PN for a long time requires special intravenous lines, and increases the risk of blood stream infections and can make the liver sick.
Feeding babies who have these CGD is often very difficult, as the intestine needs to adapt. It needs to make appropriately formed stool to eliminate wastes, but not lose too much water or too many electrolytes. There is often a lot of starting and stopping of feeds. Human milk (HM) is considered the ideal source of nutrition for all infants.
This study aims to identify whether an exclusive human milk diet (EHMD) would improve outcomes in neonates with congenital gastrointestinal disorders (CGD) and by facilitating an earlier transition off of parenteral nutrition (PN).
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 1 Minute to 1 Year (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Admission to participating NICU at less than 7 days of age
- •Birthweight >1250g and/or gestational age at birth >32 weeks
- •Less than 7 days of enteral feedings
- •Diagnosis of eligible primary "Congenital Gastointestinal Disorders" defined as: gastroschisis, omphalocele and intestinal atresias
- •Consent to the use of donor human milk products
- •Consent to participate in this study
Exclusion Criteria
- •Admission to participating NICU at >7 days of age
- •Birthweight <1250g and/or gestational age <32 weeks
- •Diagnosis of non-eligible gastrointestinal disorders: congenital diaphragmatic hernia, midgut volvulus, Hirschsprung's disease, esophageal atresia, imperforate anus
- •Evidence of significant liver dysfunction at time of enrollment (direct bilirubin >4 and transaminases elevated more than 2 SD above upper limit of normal for age)
- •Liver malformations such as biliary atresia and choledochal cyst
- •Refusal of consent
Arms & Interventions
Retrospective Control Group
Approximately 150 patients with congenital gastrointestinal disorders who were treated in the neonatal intensive care unit (NICU) at Children's Healthcare of Atlanta-Egleston and other participating institutions from 2012 to 2015, who had non-human milk (HM) diets will be identified as retrospective controls using the electronic medical records system.
Exclusive Human Milk Diet Group
A minimum of 150 patients with CGD admitted to participating NICUs who meet inclusion criteria and provide informed consent will be enrolled in the prospective arm of the study. These patients will be fed an EHMD comprised of mother's own milk (MOM) or pasteurized donor human milk (DM). Fortification will be provided with human milk derived human milk fortifier, either a human milk-based fortifier (Prolact+ H2MF®) for infants born at less than 37 weeks GA or <2,200g birth weight or the term-equivalent version (PBCLN-002) formulated for infants >37 weeks and/or >2,200g at birth. Infants will receive this EHMD until they have achieved full enteral feedings for 7 days with bowel in continuity
Intervention: Human Milk (Other)
Outcomes
Primary Outcomes
Time to full enteral feeding
Time Frame: From birth to day of life full enteral feedings for 7 days is achieved (up to 30 days)
The number of days to achieve full enteral feeding after the initial human milk feeding
Secondary Outcomes
- Number of days of parenteral nutrition(Through study completion, up to 1 year)
- Growth(Through study completion, up to 1 year)
- Difference in conjugated bilirubin levels(From birth to day of life full enteral feedings for 7 days is achieved (up to 30 days))
- Length of hospital stay(Through study completion, up to 6 months)
- Feeding interruptions(From birth to day of life full enteral feedings for 7 days is achieved (up to 30 days))
- Death rate(Through study completion, up to 1 year)
- Feeding intolerance(From birth to day of life full enteral feedings for 7 days is achieved (up to 30 days))
- Episodes of Necrotizing Enterocolitis(From birth to day of life full enteral feedings for 7 days is achieved (up to 30 days))
- Number of sepsis episodes(From birth to day of life full enteral feedings for 7 days is achieved (up to 30 days))
Investigators
Heidi Karpen
Assistant Professor
Emory University