Human Milk for Congenital Gastrointestinal Disorders

Emory University151 enrolled

Overview

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).

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

151

Conditions

Congenital Gastrointestinal Disorders

Interventions

Human MilkOTHER

Participants will receive an exclusive human milk diet comprised of mother's own milk (MOM, pasteurized donor human milk (DM) fortified with a donor-milk based fortifier (DMBF): Prolact+ for infants \<37 weeks PMA and/or or weight \<2,200g or PBCLN-002 for infants \>37 weeks PMA and/or weight \>2,200g)

Eligibility

Sex: ALLMin age: 1 MinuteMax age: 1 Year

Medical Language ↔ Plain English

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

Locations (1)

Children's Healthcare of Atlanta-Egleston

Atlanta, Georgia, United States

Outcomes

Primary Outcomes

Time to full enteral feeding

The number of days to achieve full enteral feeding after the initial human milk feeding

Time frame: From birth to day of life full enteral feedings for 7 days is achieved (up to 30 days)

Secondary Outcomes

Number of days of parenteral nutrition

The total number of days parenteral nutrition is required.

Time frame: Through study completion, up to 1 year

Growth

Compare growth parameters (weight, length and head circumference) as daily g/kg/d and z-scores birth to discharge

Time frame: Through study completion, up to 1 year

Difference in conjugated bilirubin levels

The difference in average bilirubin level will be compared between the non-human milk diet (retrospective control group) and the breast milk diet group.

Time frame: From birth to day of life full enteral feedings for 7 days is achieved (up to 30 days)

Length of hospital stay

The length of hospital stay described as the number of days spent in the hospital

Time frame: Through study completion, up to 6 months

Feeding interruptions

NPO for at least 24 hours. NPO due to elective surgeries or procedures will not be defined as feeding interruptions

Time frame: From birth to day of life full enteral feedings for 7 days is achieved (up to 30 days)

Feeding intolerance

Number of days when one or more feedings were held for clinical concerns

Data from ClinicalTrials.gov

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