Human Milk for Congenital Gastrointestinal Disorders

Not Applicable

Completed

• Conditions: Congenital Gastrointestinal Disorders
• Interventions: Other: Human Milk

• Registration Number: NCT02567292
• Lead Sponsor: Emory University

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).

Study Timeline

• Study First Submitted: 2015-10-01
• Study First Submitted QC: 2015-10-01
• Study First Posted: 2015-10-02
• Study Start: 2018-07-26
• Primary Completion: 2022-01-18
• Study Completion: 2022-01-18
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-25
• Last Update Posted: 2023-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 151

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Exclusive Human Milk Diet Group	Human Milk	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

Primary Outcome Measures

Name	Time	Method
Time to full enteral feeding	From birth to day of life full enteral feedings for 7 days is achieved (up to 30 days)	The number of days to achieve full enteral feeding after the initial human milk feeding

Secondary Outcome Measures

Name	Time	Method
Feeding intolerance	From birth to day of life full enteral feedings for 7 days is achieved (up to 30 days)	Number of days when one or more feedings were held for clinical concerns
Number of days of parenteral nutrition	Through study completion, up to 1 year	The total number of days parenteral nutrition is required.
Growth	Through study completion, up to 1 year	Compare growth parameters (weight, length and head circumference) as daily g/kg/d and z-scores birth to discharge
Difference in conjugated bilirubin levels	From birth to day of life full enteral feedings for 7 days is achieved (up to 30 days)	The difference in average bilirubin level will be compared between the non-human milk diet (retrospective control group) and the breast milk diet group.
Length of hospital stay	Through study completion, up to 6 months	The length of hospital stay described as the number of days spent in the hospital
Feeding interruptions	From birth to day of life full enteral feedings for 7 days is achieved (up to 30 days)	NPO for at least 24 hours. NPO due to elective surgeries or procedures will not be defined as feeding interruptions
Death rate	Through study completion, up to 1 year	The number of deaths between participants who receive breast milk only diets as compared to the non-breast milk diet (retrospective control group while in the neonatal intensive care unit (NICU).
Episodes of Necrotizing Enterocolitis	From birth to day of life full enteral feedings for 7 days is achieved (up to 30 days)	Number of episodes of Stage IIb NEC or greater
Number of sepsis episodes	From birth to day of life full enteral feedings for 7 days is achieved (up to 30 days)	The number of sepsis episodes will be compared between the non-breast milk diet (retrospective control group) and the breast milk diet group.

Trial Locations

Locations (1)

Children's Healthcare of Atlanta-Egleston; 🇺🇸 Atlanta, Georgia, United States