Exclusive Human Milk Feeding in Infants With Single Ventricle Physiology

NCT ID: NCT02860702

Last Updated: 2023-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2022-10-06

Brief Summary

A randomized, blinded, controlled trial to evaluate growth velocity and clinical outcomes in infants with single ventricle physiology fed an exclusive human milk diet prior to, and throughout the post-operative period following, surgical repair. Human milk is defined as expressed human milk or donor milk and its derivatives, human milk-based fortifier and human milk caloric fortifier.

The study hypothesis is that infants fed an exclusive human milk diet will have short and long term benefits, with improved wound healing, growth, and neurodevelopmental outcomes while reducing episodes of feeding intolerance and necrotizing enterocolitis (NEC).

Detailed Description

This is a single blinded (physician investigator), randomized, controlled trial to evaluate growth velocity and clinical outcomes in infants with single ventricle physiology fed an exclusive human milk diet during their initial hospitalization after birth and through the 30 days post-surgical repair feeding period or hospital discharge, whichever comes first.

Subjects will be randomized to one of two groups at birth or immediately following diagnosis if prenatal care was not obtained prior to birth. Parents who decline participation by their infants in the study will be asked to consent to data gathering on their infants who will be treated and fed per institutional practice. The data on these individuals will be summarized and evaluated descriptively in comparison with the actual trial results.

All patients will receive exclusive maternal human milk or donor human milk prior to randomization. Once randomized, patients in Group One will receive an exclusive human milk diet prior to the surgery and throughout the 30-day feeding period following surgical repair or until hospital discharge, whichever comes first. Day 1 is defined as the day of the first enteral feed post-surgery. Patients in Group Two (Control Group) will receive maternal human milk or formula or donor human milk (per standard of care at each hospital) in the pre-surgical period. In the post-surgical period the control group will receive human milk or formula, as per feeding algorithm The primary objective of this study is to evaluate growth velocity (weight velocity [g/kg/day] and weight z-score from World Health Organization (WHO) growth charts) at 30 days after the initiation of feed post-surgery for infants with single ventricle physiology who are fed an exclusive human milk diet from birth through the 30 day feeding period following surgical repair or until hospital discharge, whichever comes first.

Conditions

Congenital Heart Defect

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Exclusive Human Milk

All infants randomized to this arm will receive exclusive human milk diet with addition of human milk derived fortifier from birth to 30 days post initiation of feedings after initial palliative cardiac surgery

Group Type: EXPERIMENTAL

Human Milk Derived Fortifier

Intervention Type: OTHER

Human milk derived fortifier will be utilized to increase caloric intake in infants assigned to the exclusive human milk arm

Human/Bovine Milk

All infants randomized to this arm will receive exclusive human milk diet prior to randomization and will use either human and/or bovine milk and fortifier per the institution's standard practice 30 days post initiation of feedings after initial palliative cardiac surgery

Group Type: ACTIVE_COMPARATOR

Human/Bovine Milk

Intervention Type: OTHER

Bovine milk derived fortification

Interventions

Human Milk Derived Fortifier

Human milk derived fortifier will be utilized to increase caloric intake in infants assigned to the exclusive human milk arm

Intervention Type: OTHER

Human/Bovine Milk

Bovine milk derived fortification

Intervention Type: OTHER

Other Intervention Names

Human/Formula Milk

Eligibility Criteria

Inclusion Criteria

1. Term infants (≥37 and 0/7 weeks gestational age) ≤ 7 days old with a diagnosis of single ventricle physiology who are thought to require a single ventricle repair at the time of enrollment.

2. Infant feeding was NPO or consisted of 100% human milk diet prior to enrollment

3. Parent(s) willing to sign informed consent.

4. Parent(s) willing to comply with study follow-up procedures.

5. Require surgical palliation within the first 1 month of life.

Exclusion Criteria

1. Term infants >7 days old at the time of diagnosis.

2. <37 weeks gestation

3. Infants requiring cardio-pulmonary resuscitation prior to surgical repair.

4. Outborn infants who received enteral nutrition at the other institution prior to surgical repair. If it is uncertain if infant received even 1 bottle or a small amount of formula, infants will be excluded.

5. Major congenital abnormalities that could significantly affect survival such as:

1. Confirmed or suspected major genetic abnormalities (lethal or with extremely low probability for survival).

2. Chromosomal abnormalities: Trisomies (13, 18, 21 etc.) deletions or translocations (Turner/Williams Syndrome, DiGeorge, to name a few)

3. Major organ system abnormalities not related to a genetic syndrome that are lethal or have extremely low probability for survival (i.e, bilateral kidney intrinsic disease, pulmonary hypoplasia, Central Nervous System (CNS) malformations: Arnold Chiari, myelomeningoceles, hydranencephaly, schizencephaly, holoprosencephaly))

4. Heterotaxia

5. Metabolic disorders affecting growth: homocystinuria, methylmalonic acidemias, propionic acidemias, urea cycle defects

6. Evidence of intracerebral hemorrhage (IVH) ≥ Grade 3

7. Any comorbidity or significant clinical event prior to enrollment, deemed by the Investigator as likely to affect survival.

8. Requires Extracorporeal Membrane Oxygenation (ECMO) pre-operatively

9. Legally Authorized Representative(s) unwilling to comply with an exclusive human milk diet either in the form of mother's milk, human milk-based human milk fortifier, human milk based caloric fortifier or donor human milk during the initial hospitalization period and through the 30 day feeding period after surgical repair or hospital discharge, whichever comes first.

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 7 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Prolacta Bioscience

INDUSTRY

Sponsor Role: collaborator

Baylor College of Medicine

OTHER

Sponsor Role: collaborator

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: collaborator

University of Oklahoma

OTHER

Sponsor Role: collaborator

Ann & Robert H Lurie Children's Hospital of Chicago

OTHER

Sponsor Role: collaborator

Cook Children's Medical Center

OTHER

Sponsor Role: collaborator

Children's Hospital of Orange County

OTHER

Sponsor Role: collaborator

University of Texas

OTHER

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: collaborator

The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cynthia Blanco, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center at San Antonio

Locations

Loma Linda University

Loma Linda, California, United States

Los Angeles Children's Hospital

Los Angeles, California, United States

Children's Hospital Orange County

Orange, California, United States

University of Florida Children's Hospital

Gainesville, Florida, United States

Lurie Children's Hospital

Chicago, Illinois, United States

Columbia University

New York, New York, United States

Cincinatti Children's Hospital Medical Center

Cincinnati, Ohio, United States

OU Children's Hospital at OU Medical Center

Oklahoma City, Oklahoma, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Cook Children's Medical

Fort Worth, Texas, United States

Texas Children's Hospital

Houston, Texas, United States

University Health System

San Antonio, Texas, United States

Countries

United States

References

Blanco CL, Hair A, Justice LB, Roddy D, Bonagurio K, Williams PK, Machado D, Marino BS, Chi A, Takao C, Gordon EE, Ashrafi A, Cacho N, Pruetz JD, Costello JM, Cooper DS; Cardiac Neonate Nutrition Study Group. A Randomized Trial of an Exclusive Human Milk Diet in Neonates with Single Ventricle Physiology. J Pediatr. 2023 May;256:105-112.e4. doi: 10.1016/j.jpeds.2022.11.043. Epub 2022 Dec 14.

Reference Type: DERIVED

PMID: 36528055 (View on PubMed)

Other Identifiers

HSC20150779H

Identifier Type: -

Identifier Source: org_study_id