Exclusive Human Milk Feeding in Infants With Single Ventricle Physiology

• ClinicalTrials.gov Identifier: NCT02860702
• Recruitment Status: Active, not recruiting
• First Posted: August 9, 2016
• Last Update Posted: October 12, 2022
• Sponsor: The University of Texas Health Science Center at San Antonio
• Collaborators: Prolacta Bioscience; Baylor College of Medicine; Children's Hospital Medical Center, Cincinnati; Columbia University; University of Oklahoma; Ann & Robert H Lurie Children's Hospital of Chicago; Cook Children's Medical Center; Children's Hospital of Orange County; University of Texas; University of Florida
• Information provided by (Responsible Party): The University of Texas Health Science Center at San Antonio

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Congenital Heart Defect	Other: Human Milk Derived Fortifier; Other: Human/Bovine Milk	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 16 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Prevention
• 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
• Actual Study Start Date: July 2016
• Actual Primary Completion Date: December 31, 2020
• Estimated Study Completion Date: June 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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	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
Active Comparator: 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	Other: Human/Bovine Milk; Bovine milk derived fortification; Other Name: Human/Formula Milk

Outcome Measures

Primary Outcome Measures :

1. growth velocity [ Time Frame: 30 days ]
   weight velocity in g/kg/day
2. growth velocity [ Time Frame: 30 days ]
   weight z-score 30 days post 1st operation

Secondary Outcome Measures :

1. linear growth rate [ Time Frame: 6 months ]
   cm/week
2. linear growth rate [ Time Frame: 6 months ]
   z-score
3. head circumference growth rate [ Time Frame: 6 months ]
   cm/week
4. head circumference growth rate [ Time Frame: 6 months ]
   z-score
5. Feeding Intolerance [ Time Frame: 30 days ]
   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.
6. Length of stay [ Time Frame: up to 24 months ]
   time hospitalized after 1st surgery
7. Sepsis [ Time Frame: 30 days ]
   Sepsis 30 days post 1st operation
8. Necrotizing enterocolitis [ Time Frame: 30 days ]
   NEC 30 days post 1st operation
9. wound infections [ Time Frame: 30 days ]
   wound infection 30 days post 1st operation
10. wound dehiscence [ Time Frame: 30 days ]
    wound dehiscence 30 days post 1st operation
11. parenteral nutrition [ Time Frame: 30 days ]
    in days, during the 30 day post 1st operation

Eligibility Criteria

• Ages Eligible for Study: 1 Day to 7 Days (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, California

Loma Linda University

Loma Linda, California, United States, 92354

Los Angeles Children's Hospital

Los Angeles, California, United States, 90027

Children's Hospital Orange County

Orange, California, United States, 92868

United States, Florida

University of Florida Children's Hospital

Gainesville, Florida, United States, 32610

United States, Illinois

Lurie Children's Hospital

Chicago, Illinois, United States, 60611

United States, New York

Columbia University

New York, New York, United States, 10027

United States, Ohio

Cincinatti Children's Hospital Medical Center

Cincinnati, Ohio, United States, 45229

United States, Oklahoma

OU Children's Hospital at OU Medical Center

Oklahoma City, Oklahoma, United States, 73104

United States, Texas

University of Texas Southwestern Medical Center

Dallas, Texas, United States, 75390

Cook Children's Medical

Fort Worth, Texas, United States, 76104

Texas Children's Hospital

Houston, Texas, United States, 77030

University Health System

San Antonio, Texas, United States, 78229

Sponsors and Collaborators

The University of Texas Health Science Center at San Antonio

Prolacta Bioscience

Baylor College of Medicine

Children's Hospital Medical Center, Cincinnati

Columbia University

University of Oklahoma

Ann & Robert H Lurie Children's Hospital of Chicago

Cook Children's Medical Center

Children's Hospital of Orange County

University of Texas

University of Florida

Investigators

• Principal Investigator: Cynthia Blanco, MD; The University of Texas Health Science Center at San Antonio

More Information

• Responsible Party: The University of Texas Health Science Center at San Antonio
• ClinicalTrials.gov Identifier: NCT02860702
• Other Study ID Numbers: HSC20150779H
• First Posted: August 9, 2016
• Last Update Posted: October 12, 2022
• Last Verified: October 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: It is a blinded study

Keywords provided by The University of Texas Health Science Center at San Antonio:

Single Ventricle; Congenital Heart Defect

Additional relevant MeSH terms:

Heart Defects, Congenital; Univentricular Heart; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities