Exclusive Human Milk Feeding in Infants With Single Ventricle Physiology
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
1 other identifier
interventional
16
1 country
12
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2016
Longer than P75 for not_applicable
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2016
CompletedFirst Submitted
Initial submission to the registry
July 28, 2016
CompletedFirst Posted
Study publicly available on registry
August 9, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 6, 2022
CompletedSeptember 26, 2023
September 1, 2023
4.5 years
July 28, 2016
September 25, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
growth velocity
weight velocity in g/kg/day
30 days
growth velocity
weight z-score 30 days post 1st operation
30 days
Secondary Outcomes (11)
linear growth rate
6 months
linear growth rate
6 months
head circumference growth rate
6 months
head circumference growth rate
6 months
Feeding Intolerance
30 days
- +6 more secondary outcomes
Study Arms (2)
Exclusive Human Milk
EXPERIMENTALAll 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
Human/Bovine Milk
ACTIVE COMPARATORAll 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
Interventions
Human milk derived fortifier will be utilized to increase caloric intake in infants assigned to the exclusive human milk arm
Bovine milk derived fortification
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The University of Texas Health Science Center at San Antoniolead
- Prolacta Biosciencecollaborator
- Baylor College of Medicinecollaborator
- Children's Hospital Medical Center, Cincinnaticollaborator
- Columbia Universitycollaborator
- University of Oklahomacollaborator
- Ann & Robert H Lurie Children's Hospital of Chicagocollaborator
- Cook Children's Medical Centercollaborator
- Children's Hospital of Orange Countycollaborator
- University of Texascollaborator
- University of Floridacollaborator
Study Sites (12)
Loma Linda University
Loma Linda, California, 92354, United States
Los Angeles Children's Hospital
Los Angeles, California, 90027, United States
Children's Hospital Orange County
Orange, California, 92868, United States
University of Florida Children's Hospital
Gainesville, Florida, 32610, United States
Lurie Children's Hospital
Chicago, Illinois, 60611, United States
Columbia University
New York, New York, 10027, United States
Cincinatti Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
OU Children's Hospital at OU Medical Center
Oklahoma City, Oklahoma, 73104, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
Cook Children's Medical
Fort Worth, Texas, 76104, United States
Texas Children's Hospital
Houston, Texas, 77030, United States
University Health System
San Antonio, Texas, 78229, United States
Related Publications (1)
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.
PMID: 36528055DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cynthia Blanco, MD
The University of Texas Health Science Center at San Antonio
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 28, 2016
First Posted
August 9, 2016
Study Start
July 1, 2016
Primary Completion
December 31, 2020
Study Completion
October 6, 2022
Last Updated
September 26, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share
It is a blinded study