Human Milk for Congenital Gastrointestinal Disorders (HM for CGD)

Effects of an Exclusive 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).

Study Overview

• Status: Completed
• Conditions: Congenital Gastrointestinal Disorders
• Intervention / Treatment: Other: Human Milk

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 Type: Interventional
• Enrollment (Actual): 151
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Children's Healthcare of Atlanta-Egleston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 minute to 1 year (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Retrospective Control Group; 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.
Experimental: Exclusive Human Milk Diet Group; 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	Other: Human Milk; 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)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of days of parenteral nutrition	The total number of days parenteral nutrition is required.	Through study completion, up to 1 year
Length of hospital stay	The length of hospital stay described as the number of days spent in the hospital	Through study completion, up to 6 months
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.	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	From birth to day of life full enteral feedings for 7 days is achieved (up to 30 days)
Feeding interruptions	NPO for at least 24 hours. NPO due to elective surgeries or procedures will not be defined as feeding interruptions	From birth to day of life full enteral feedings for 7 days is achieved (up to 30 days)
Episodes of Necrotizing Enterocolitis	Number of episodes of Stage IIb NEC or greater	From birth to day of life full enteral feedings for 7 days is achieved (up to 30 days)
Number of sepsis episodes	The number of sepsis episodes will be compared between the non-breast milk diet (retrospective control group) and the breast milk diet group.	From birth to day of life full enteral feedings for 7 days is achieved (up to 30 days)
Death rate	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).	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	Through study completion, up to 1 year

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: Prolacta Bioscience; Chatham Valley Foundation
• Investigators: Principal Investigator: Heidi Karpen, MD, Emory University

Publications and helpful links

General Publications

• Shinnick JK, Wang E, Hulbert C, McCracken C, Sarson GY, Piazza A, Karpen H, Durham MM. Effects of a Breast Milk Diet on Enteral Feeding Outcomes of Neonates with Gastrointestinal Disorders. Breastfeed Med. 2016 Aug;11(6):286-292. doi: 10.1089/bfm.2016.0002. Epub 2016 Jun 22.

Study record dates

Study Major Dates

• Study Start (Actual): July 26, 2018
• Primary Completion (Actual): January 18, 2022
• Study Completion (Actual): January 18, 2022

Study Registration Dates

• First Submitted: October 1, 2015
• First Submitted That Met QC Criteria: October 1, 2015
• First Posted (Estimated): October 2, 2015

Study Record Updates

• Last Update Posted (Actual): August 28, 2023
• Last Update Submitted That Met QC Criteria: August 25, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Neonatal; Digestive Disease and Disorders; Pediatric Disorders
• Additional Relevant MeSH Terms: Pathologic Processes; Gastrointestinal Diseases; Digestive System Diseases
• Other Study ID Numbers: IRB00080481

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No