Human Milk for Congenital Gastrointestinal Disorders

  • STATUS
    Recruiting
  • days left to enroll
    24
  • participants needed
    150
  • sponsor
    Emory University
Updated on 14 November 2021

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).

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).

Details
Condition Congenital Gastrointestinal Disorders
Treatment breast milk, Human Milk, Human Milk
Clinical Study IdentifierNCT02567292
SponsorEmory University
Last Modified on14 November 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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