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Exclusive Human Milk Feeding in Infants With Single Ventricle Physiology

Primary Purpose

Congenital Heart Defect

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Human Milk Derived Fortifier
Human/Bovine Milk
Sponsored by
The University of Texas Health Science Center at San Antonio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Congenital Heart Defect focused on measuring Single Ventricle, Congenital Heart Defect

Eligibility Criteria

1 Day - 7 Days (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Loma Linda University
  • Los Angeles Children's Hospital
  • Children's Hospital Orange County
  • University of Florida Children's Hospital
  • Lurie Children's Hospital
  • Columbia University
  • Cincinatti Children's Hospital Medical Center
  • OU Children's Hospital at OU Medical Center
  • University of Texas Southwestern Medical Center
  • Cook Children's Medical
  • Texas Children's Hospital
  • University Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Exclusive Human Milk

Human/Bovine Milk

Arm Description

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

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

Outcomes

Primary Outcome Measures

growth velocity
weight velocity in g/kg/day
growth velocity
weight z-score 30 days post 1st operation

Secondary Outcome Measures

linear growth rate
cm/week
linear growth rate
z-score
head circumference growth rate
cm/week
head circumference growth rate
z-score
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.
Length of stay
time hospitalized after 1st surgery
Sepsis
Sepsis 30 days post 1st operation
Necrotizing enterocolitis
NEC 30 days post 1st operation
wound infections
wound infection 30 days post 1st operation
wound dehiscence
wound dehiscence 30 days post 1st operation
parenteral nutrition
in days, during the 30 day post 1st operation

Full Information

First Posted
July 28, 2016
Last Updated
September 25, 2023
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
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1. Study Identification

Unique Protocol Identification Number
NCT02860702
Brief Title
Exclusive Human Milk Feeding in Infants With Single Ventricle Physiology
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
July 2016 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
October 6, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the 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

4. Oversight

Data Monitoring Committee
Yes

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Defect
Keywords
Single Ventricle, Congenital Heart Defect

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exclusive Human Milk
Arm Type
Experimental
Arm Description
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
Arm Title
Human/Bovine Milk
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Human Milk Derived Fortifier
Intervention Description
Human milk derived fortifier will be utilized to increase caloric intake in infants assigned to the exclusive human milk arm
Intervention Type
Other
Intervention Name(s)
Human/Bovine Milk
Other Intervention Name(s)
Human/Formula Milk
Intervention Description
Bovine milk derived fortification
Primary Outcome Measure Information:
Title
growth velocity
Description
weight velocity in g/kg/day
Time Frame
30 days
Title
growth velocity
Description
weight z-score 30 days post 1st operation
Time Frame
30 days
Secondary Outcome Measure Information:
Title
linear growth rate
Description
cm/week
Time Frame
6 months
Title
linear growth rate
Description
z-score
Time Frame
6 months
Title
head circumference growth rate
Description
cm/week
Time Frame
6 months
Title
head circumference growth rate
Description
z-score
Time Frame
6 months
Title
Feeding Intolerance
Description
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.
Time Frame
30 days
Title
Length of stay
Description
time hospitalized after 1st surgery
Time Frame
up to 24 months
Title
Sepsis
Description
Sepsis 30 days post 1st operation
Time Frame
30 days
Title
Necrotizing enterocolitis
Description
NEC 30 days post 1st operation
Time Frame
30 days
Title
wound infections
Description
wound infection 30 days post 1st operation
Time Frame
30 days
Title
wound dehiscence
Description
wound dehiscence 30 days post 1st operation
Time Frame
30 days
Title
parenteral nutrition
Description
in days, during the 30 day post 1st operation
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
7 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Infant feeding was NPO or consisted of 100% human milk diet prior to enrollment Parent(s) willing to sign informed consent. Parent(s) willing to comply with study follow-up procedures. Require surgical palliation within the first 1 month of life. Exclusion Criteria: Term infants >7 days old at the time of diagnosis. <37 weeks gestation Infants requiring cardio-pulmonary resuscitation prior to surgical repair. 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. Major congenital abnormalities that could significantly affect survival such as: Confirmed or suspected major genetic abnormalities (lethal or with extremely low probability for survival). Chromosomal abnormalities: Trisomies (13, 18, 21 etc.) deletions or translocations (Turner/Williams Syndrome, DiGeorge, to name a few) 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)) Heterotaxia Metabolic disorders affecting growth: homocystinuria, methylmalonic acidemias, propionic acidemias, urea cycle defects Evidence of intracerebral hemorrhage (IVH) ≥ Grade 3 Any comorbidity or significant clinical event prior to enrollment, deemed by the Investigator as likely to affect survival. Requires Extracorporeal Membrane Oxygenation (ECMO) pre-operatively 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cynthia Blanco, MD
Organizational Affiliation
The University of Texas Health Science Center at San Antonio
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loma Linda University
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
Los Angeles Children's Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Children's Hospital Orange County
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
University of Florida Children's Hospital
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Lurie Children's Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10027
Country
United States
Facility Name
Cincinatti Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
OU Children's Hospital at OU Medical Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Cook Children's Medical
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University Health System
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
It is a blinded study

Learn more about this trial

Exclusive Human Milk Feeding in Infants With Single Ventricle Physiology

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