Clinical trial NCT02567292: Human Milk for Congenital Gastrointestinal Disorders
Official title: Effects of an Exclusive Human Milk Diet on Enteral Feeding Outcomes of Neonates With Congenital Gastrointestinal Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congenital Gastrointestinal Disorders
Keywords: Digestive Disease and Disorders
Neonatal
Pediatric Disorders
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Chatham Valley Foundation
name: Prolacta Bioscience
First posted: 2015-10-02
Enrollment: 151
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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).

Eligibility criteria: Inclusion Criteria:

1. Admission to participating NICU at less than 7 days of age
2. Birthweight \>1250g and/or gestational age at birth \>32 weeks
3. Less than 7 days of enteral feedings
4. Diagnosis of eligible primary "Congenital Gastointestinal Disorders" defined as: gastroschisis, omphalocele and intestinal atresias
5. Consent to the use of donor human milk products
6. Consent to participate in this study

Exclusion Criteria:

1. Admission to participating NICU at \>7 days of age
2. Birthweight \<1250g and/or gestational age \<32 weeks
3. Diagnosis of non-eligible gastrointestinal disorders: congenital diaphragmatic hernia, midgut volvulus, Hirschsprung's disease, esophageal atresia, imperforate anus
4. 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)
5. Liver malformations such as biliary atresia and choledochal cyst
6. Refusal of consent

Primary outcomes:
measure: Time to full enteral feeding
timeFrame: From birth to day of life full enteral feedings for 7 days is achieved (up to 30 days)
Secondary outcomes:
measure: Number of days of parenteral nutrition
timeFrame: Through study completion, up to 1 year
measure: Growth
timeFrame: Through study completion, up to 1 year
measure: Difference in conjugated bilirubin levels
timeFrame: From birth to day of life full enteral feedings for 7 days is achieved (up to 30 days)
measure: Length of hospital stay
timeFrame: Through study completion, up to 6 months
measure: Feeding interruptions
timeFrame: From birth to day of life full enteral feedings for 7 days is achieved (up to 30 days)
measure: Feeding intolerance
timeFrame: From birth to day of life full enteral feedings for 7 days is achieved (up to 30 days)
measure: Episodes of Necrotizing Enterocolitis
timeFrame: From birth to day of life full enteral feedings for 7 days is achieved (up to 30 days)
measure: Number of sepsis episodes
timeFrame: From birth to day of life full enteral feedings for 7 days is achieved (up to 30 days)
measure: Death rate
timeFrame: Through study completion, up to 1 year
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta-Egleston
state: Georgia
Study officials:
affiliation: Emory University
name: Heidi Karpen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shinnick JK, Wang E, Hulbert C, McCracken C, Sarson GY, Piazza A, Karpen H, Durham MM. Effects of a Breast Milk Diet on Enteral Feeding Outcomes of Neonates with Gastrointestinal Disorders. Breastfeed Med. 2016 Aug;11(6):286-292. doi: 10.1089/bfm.2016.0002. Epub 2016 Jun 22.