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Exclusive Human Milk Feeding in Infants With Single Ventricle Physiology

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ClinicalTrials.gov Identifier: NCT02860702
Recruitment Status : Recruiting
First Posted : August 9, 2016
Last Update Posted : October 22, 2019
Sponsor:
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

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 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
Study Start Date : July 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


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




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   up 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02860702


Contacts
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Contact: Amy Piacentino, BScN CRAII 310-748-7237 APiacentino@prolacta.com
Contact: Robin Tragus, RN 210-567-5262 tragus@uthscsa.edu

Locations
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United States, California
Loma Linda University Not yet recruiting
Loma Linda, California, United States, 92354
Contact: Mitch Goldstein, MD    909-558-7448    Mgoldstein@Iiu.edu   
Contact: Lila Dalton       Ldalton@Iiu.edu   
Los Angeles Children's Hospital Not yet recruiting
Los Angeles, California, United States, 90027
Contact: Cheryl Takao, MD    323-361-1871    Ctakao@chla.usc.edu   
Contact: Jay Pruetz, MD       Jpruetz@chla.usc.edu   
Children's Hospital Orange County Recruiting
Orange, California, United States, 92868
Contact: Amir Ashrafi, MD    714-509-4373    amir.asrafi@gmail.com   
Contact: Caroline Steele    714-509-3023    CSteele@choc.org   
United States, Florida
University of Florida Children's Hospital Recruiting
Gainesville, Florida, United States, 32610
Contact: Nicole Cacho, MD       nicole.cacho@peds.ufl.edu   
Contact: Desiree Machado, MD    352-273-7770    desireemachado@ufl.edu   
United States, Illinois
Lurie Children's Hospital Recruiting
Chicago, Illinois, United States, 60611
Contact: Bradley Marino, MD    800-543-7362    bradley.marino@northwestern.edu   
Contact: Kathleen Van't Hof    312-227-1549    kvanthof@luriechildrens.org   
Principal Investigator: Bradley Marino, MD         
United States, New York
Columbia University Recruiting
New York, New York, United States, 10027
Contact: Sudha Kashyap, MD    212-305-9034    sk48@columbia.edu   
Contact: Marianne Garland, MB    212-305-0954    mg71@columbia.edu   
Principal Investigator: Sudha Kashyap, MD         
United States, Ohio
Cincinatti Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Bryan Allaben, MS    513-803-2995    Bryan.Allaben@cchmc.org   
Contact: Michelle Faust    513-803-0349    michelle.faust@cchmc.org   
Principal Investigator: David Cooper, MD         
Principal Investigator: Lindsey Justice, NP         
United States, Oklahoma
OU Children's Hospital at OU Medical Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Patricia Williams, MD    405-271-5215 ext 41571    patricia-k-williams@ouhsc.edu   
Contact: Mike McCoy, MS       mike-mccoy@ouhsc.edu   
Principal Investigator: Patricia Williams, MD         
United States, Texas
University of Texas Southwestern Medical Center Not yet recruiting
Dallas, Texas, United States, 75390
Contact: Joshua Wolovits, MD       joshua.wolovits@utsouthwestern.edu   
Contact: Erin Gordon, MD    214-456-1811    erin.gordon@utsouthwestern.edu   
Principal Investigator: Erin Gordon, MD         
Cook Children's Medical Recruiting
Fort Worth, Texas, United States, 76104
Contact: Kelli Brazzel, RN    682-885-6837    kelli.brazzel@cookchildrens.org   
Contact: Beth Camacho, MSN    682-885-3395    beth.camacho@cookchildrens.org   
Principal Investigator: Victor Levy, MD         
Texas Children's Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Heejy Yang    832-826-7991    jpunger1@texaschildrens.org   
Contact: Amy Hair, MD    832-826-3719    abhair@texaschildrens.org   
Principal Investigator: Amy Hair, MD         
University Health System Recruiting
San Antonio, Texas, United States, 78229
Contact: Robin Tragus, RN    210-567-5262    tragus@uthscsa.edu   
Contact: Laurie Weaver, RN    2108872868    laurie.weaver@uhs-sa.com   
Principal Investigator: Cynthia L Blanco, MD         
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
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Principal Investigator: Cynthia Blanco, MD The University of Texas Health Science Center at San Antonio
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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    Key Record Dates
Last Update Posted: October 22, 2019
Last Verified: October 2019
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:
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Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities