Human Milk for Congenital Gastrointestinal Disorders

NCT02567292 | Completed

• 1 other identifier: IRB00080481
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 1

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).

Conditions

Congenital Gastrointestinal Disorders

Keywords

Digestive Disease and Disorders; Neonatal; Pediatric Disorders

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Number of days of parenteral nutrition

  Through study completion, up to 1 year

• Growth

  Through study completion, up to 1 year

• Difference in conjugated bilirubin levels

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

• Length of hospital stay

  Through study completion, up to 6 months

• Feeding interruptions

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

Study Arms (2)

Retrospective Control Group

NO INTERVENTION

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.

Exclusive Human Milk Diet Group

EXPERIMENTAL

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

Interventions

Human Milk OTHER

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)

Exclusive Human Milk Diet Group

Eligibility Criteria

• Age: 1 Minute - 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead
• Chatham Valley Foundation: collaborator
• Prolacta Bioscience: collaborator

Study Sites (1)

Children's Healthcare of Atlanta-Egleston

Atlanta, Georgia, 30322, United States

Location

Related Publications (1)

• 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.

  PMID: 27331420 RESULT

MeSH Terms

Conditions

Digestive System Diseases; Disease

Interventions

Milk, Human

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Milk; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Dairy Products; Food; Food and Beverages

Study Officials

• Heidi Karpen, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 1, 2015
• First Posted: October 2, 2015
• Study Start: July 26, 2018
• Primary Completion: January 18, 2022
• Study Completion: January 18, 2022
• Last Updated: August 28, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)