Exclusive Human Milk Feeding in Infants With Single Ventricle Physiology

Congenital Heart Defect Clinical Trial

Official title:

A Randomized Controlled Trial to Evaluate Growth Velocity and Clinical Outcomes of Infants With Single Ventricle Physiology Fed an Exclusive Human Milk Diet With Early Nutritional Fortification Following Surgical Repair

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02860702
• Other study ID #: HSC20150779H
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: October 6, 2022

Study information

• Verified date: September 2023
• Source: The University of Texas Health Science Center at San Antonio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: October 6, 2022
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 7 Days

Eligibility

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.

Related Conditions & MeSH terms

• Congenital Heart Defect
• Heart Defects, Congenital
• Univentricular Heart

Intervention

Other:
• Human Milk Derived Fortifier
Human milk derived fortifier will be utilized to increase caloric intake in infants assigned to the exclusive human milk arm
• Human/Bovine Milk
Bovine milk derived fortification

Locations

Country	Name	City	State
United States	Lurie Children's Hospital	Chicago	Illinois
United States	Cincinatti Children's Hospital Medical Center	Cincinnati	Ohio
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	Cook Children's Medical	Fort Worth	Texas
United States	University of Florida Children's Hospital	Gainesville	Florida
United States	Texas Children's Hospital	Houston	Texas
United States	Loma Linda University	Loma Linda	California
United States	Los Angeles Children's Hospital	Los Angeles	California
United States	Columbia University	New York	New York
United States	OU Children's Hospital at OU Medical Center	Oklahoma City	Oklahoma
United States	Children's Hospital Orange County	Orange	California
United States	University Health System	San Antonio	Texas

Sponsors (11)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio	Ann & Robert H Lurie Children's Hospital of Chicago, Baylor College of Medicine, Children's Hospital Medical Center, Cincinnati, Children's Hospital of Orange County, Columbia University, Cook Children's Medical Center, Prolacta Bioscience, University of Florida, University of Oklahoma, University of Texas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	growth velocity	weight velocity in g/kg/day	30 days
Primary	growth velocity	weight z-score 30 days post 1st operation	30 days
Secondary	linear growth rate	cm/week	6 months
Secondary	linear growth rate	z-score	6 months
Secondary	head circumference growth rate	cm/week	6 months
Secondary	head circumference growth rate	z-score	6 months
Secondary	Feeding Intolerance	defined as nil per os (NPO) for at least 24 in the 30 days of post-surgery enteral feeding period (day 1 is the first day of feeding post-op), NPO due to elective surgeries or procedures will not be defined as feeding intolerance.	30 days
Secondary	Length of stay	time hospitalized after 1st surgery	up to 24 months
Secondary	Sepsis	Sepsis 30 days post 1st operation	30 days
Secondary	Necrotizing enterocolitis	NEC 30 days post 1st operation	30 days
Secondary	wound infections	wound infection 30 days post 1st operation	30 days
Secondary	wound dehiscence	wound dehiscence 30 days post 1st operation	30 days
Secondary	parenteral nutrition	in days, during the 30 day post 1st operation	30 days