Human Milk for Congenital Gastrointestinal Disorders



Status:Recruiting
Conditions:Gastrointestinal, Digestive Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:Any - 1
Updated:8/8/2018
Start Date:July 26, 2018
End Date:April 30, 2021
Contact:Heidi Karpen, MD
Email:heidi.karpen@emory.edu
Phone:404-727-3375

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Effects of an Exclsuive Human Milk Diet on Enteral Feeding Outcomes of Neonates With Congenital Gastrointestinal Disorders

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).

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
We found this trial at
1
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Atlanta, Georgia 30322
Phone: 404-727-3375
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