Human Milk for Congenital Gastrointestinal Disorders (HM for CGD)

• ClinicalTrials.gov Identifier: NCT02567292
• Recruitment Status: Completed
• First Posted: October 2, 2015
• Last Update Posted: August 31, 2022
• Sponsor: Emory University
• Collaborators: Chatham Valley Foundation; Prolacta Bioscience
• Information provided by (Responsible Party): Heidi Karpen, Emory University

Tracking Information

• First Submitted Date: October 1, 2015
• First Posted Date: October 2, 2015
• Last Update Posted Date: August 31, 2022
• Actual Study Start Date: July 26, 2018
• Actual Primary Completion Date: January 18, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 26, 2018)

Time to full enteral feeding [ Time Frame: 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

Original Primary Outcome Measures (submitted: October 1, 2015)

Length of hospital stay [ Time Frame: Post initial feeding (Up to ten days) ]

The length of hospital stay described as the number of days spent in the hospital after the initial breast milk feeding.

Current Secondary Outcome Measures (submitted: April 26, 2018)

• Number of days of parenteral nutrition [ Time Frame: Through study completion, up to 1 year ]
  The total number of days parenteral nutrition is required.
• Length of hospital stay [ Time Frame: Through study completion, up to 6 months ]
  The length of hospital stay described as the number of days spent in the hospital
• Difference in conjugated bilirubin levels [ Time Frame: 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.
• Feeding intolerance [ Time Frame: 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
• Feeding interruptions [ Time Frame: 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
• Episodes of Necrotizing Enterocolitis [ Time Frame: 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 [ Time Frame: 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.
• Death rate [ Time Frame: 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).

Original Secondary Outcome Measures (submitted: October 1, 2015)

• Time to full enteral feeding [ Time Frame: Post initial feeding (Up to ten days) ]
  The number of days to achieve full enteral feeding after the initial breast milk feeding.
• Number of days of parenteral nutrition [ Time Frame: Post initial feeding (Up to ten days) ]
  The total number of days parenteral nutrition is required.
• Difference in bilirubin levels [ Time Frame: Post initial feeding (Up to ten days) ]
  The difference in average bilirubin level will be compared between the non-breast milk diet (retrospective control group) and the breast milk diet group.
• Number of sepsis episodes [ Time Frame: Post initial feeding (Up to ten days) ]
  The number of sepsis episodes will be compared between the non-breast milk diet (retrospective control group) and the breast milk diet group.
• Death rate [ Time Frame: Post initial feeding (Up to ten days) ]
  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).

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Human Milk for Congenital Gastrointestinal Disorders
• Official Title: Effects of an Exclusive Human Milk Diet on Enteral Feeding Outcomes of Neonates With Congenital Gastrointestinal Disorders
• 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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Other
• Condition: Congenital Gastrointestinal Disorders

Intervention

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)

Study Arms

• 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
  Intervention: Other: Human Milk

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 26, 2022): 151
• Original Estimated Enrollment (submitted: October 1, 2015): 100
• Actual Study Completion Date: January 18, 2022
• Actual Primary Completion Date: January 18, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 1 Minute to 1 Year (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02567292
• Other Study ID Numbers: IRB00080481
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Heidi Karpen, Emory University
• Original Responsible Party: Megan Durham, Emory University, Associate Professor
• Current Study Sponsor: Emory University
• Original Study Sponsor: Same as current

Collaborators

• Chatham Valley Foundation
• Prolacta Bioscience

Investigators

• Principal Investigator: Heidi Karpen, MD; Emory University

• PRS Account: Emory University
• Verification Date: August 2022