Human Milk for Congenital Gastrointestinal Disorders (HM for CGD)

Emory University

Status: Completed

Conditions: Congenital Gastrointestinal Disorders

Treatments: Other: Human Milk

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02567292

IRB00080481

Details and patient eligibility

About

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).

Full 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).

Enrollment: 151 patients

Sex: All

Ages: 1 minute to 1 year old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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151 participants in 2 patient groups

Retrospective Control Group

No Intervention group

Description:

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

Experimental group

Description:

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

Treatment:

Other: Human Milk