Congenital Heart DefectNCT02860702
Exclusive Human Milk Feeding in Infants With Single Ventricle Physiology
A study testing Human Milk Derived Fortifier and Human/Bovine Milk in people with Congenital Heart Defect, run by The University of Texas Health Science Center at San Antonio at 12 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 1 day to 7 days
- Conditions the study is for
- Congenital Heart Defect
- What is being tested?
- Human Milk Derived Fortifier and Human/Bovine Milk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 12 sitesUnited States
- Study dates
- Jul 2016to 6 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 7 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 14Show fewer
- 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.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Lurie Children's Hospital
Chicago, Illinois, 60611
Cincinatti Children's Hospital Medical Center
Cincinnati, Ohio, 45229
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Cook Children's Medical
Fort Worth, Texas, 76104
University of Florida Children's Hospital
Gainesville, Florida, 32610
Texas Children's Hospital
Houston, Texas, 77030
Loma Linda University
Loma Linda, California, 92354
Los Angeles Children's Hospital
Los Angeles, California, 90027
Columbia University
New York, New York, 10027
OU Children's Hospital at OU Medical Center
Oklahoma City, Oklahoma, 73104
Children's Hospital Orange County
Orange, California, 92868
University Health System
San Antonio, Texas, 78229
About this study
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
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).
Read the 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.
- Conditions
- Congenital Heart Defect
- Being tested
- Human Milk Derived Fortifier, Human/Bovine Milk
- Keywords
- Single Ventricle, Congenital Heart Defect
- Medical subject headings
- Heart Defects, Congenital, Univentricular Heart
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human Milk Derived FortifierOther
Human milk derived fortifier will be utilized to increase caloric intake in infants assigned to the exclusive human milk arm
Human/Bovine MilkOther
Also called Human/Formula Milk
Bovine milk derived fortification
| Study group | Role | What they receive |
|---|---|---|
| Exclusive Human Milk | Experimental | 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 Receives: Other: Human Milk Derived Fortifier |
| Human/Bovine Milk | Active comparator | 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 Receives: Other: Human/Bovine Milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
growth velocity
weight velocity in g/kg/day
Measured: 30 days
growth velocity
weight z-score 30 days post 1st operation
Measured: 30 days
Secondary outcomes (11)
linear growth rate
cm/week
Measured: 6 months
linear growth rate
z-score
Measured: 6 months
head circumference growth rate
cm/week
Measured: 6 months
head circumference growth rate
z-score
Measured: 6 months
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.
Measured: 30 days
Length of stay
time hospitalized after 1st surgery
Measured: up to 24 months
Sepsis
Sepsis 30 days post 1st operation
Measured: 30 days
Necrotizing enterocolitis
NEC 30 days post 1st operation
Measured: 30 days
wound infections
wound infection 30 days post 1st operation
Measured: 30 days
wound dehiscence
wound dehiscence 30 days post 1st operation
Measured: 30 days
parenteral nutrition
in days, during the 30 day post 1st operation
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2016 (estimated)
- Study startJul 2016
- Primary completion31 Dec 2020
- Study completion6 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart DefectStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Cynthia Blanco, MD, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02860702
- Sponsor's protocol ID
- HSC20150779H
- Status last verified
- Sep 2023
- First submitted
- 28 Jul 2016
- Last updated
- 26 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: It is a blinded study
Publications
Blanco CL, Justice LB, Roddy D, Alimbetov D, Cooper DS, Hair AB; Cardiac Neonate Nutrition Study Group. A randomized trial of an exclusive human milk diet in neonates with single-ventricle physiology: 3 and 6 months follow-up outcomes. Pediatr Res. 2026 Jul 21. doi: 10.1038/s41390-026-05255-2. Online ahead of print.
PubMed 42481630Blanco 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.
PubMed 36528055
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02860702
- Acronym / sponsor ID
- HSC20150779H
- Conditions
- Congenital Heart Defect
- Keywords
- Single Ventricle, Congenital Heart Defect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- 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
- Study start
- Jul 2016 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 6 Oct 2022 (actual)
- First posted
- 9 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exclusive Human Milk | Experimental | Other: Human Milk Derived FortifierAll 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 comparator | Other: Human/Bovine MilkAll 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 |
Who may qualify
- Ages
- 1 day to 7 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Human Milk Derived FortifierHuman milk derived fortifier will be utilized to increase caloric intake in infants assigned to the exclusive human milk arm | Other | Exclusive Human Milk |
| Human/Bovine MilkAlso: Human/Formula MilkBovine milk derived fortification | Other | Human/Bovine Milk |
Primary outcome
growth velocity
Time frame: 30 days
weight velocity in g/kg/day
growth velocity
Time frame: 30 days
weight z-score 30 days post 1st operation
11 secondary outcomes
linear growth rate
Time frame: 6 months
linear growth rate
Time frame: 6 months
head circumference growth rate
Time frame: 6 months
head circumference growth rate
Time frame: 6 months
Feeding Intolerance
Time frame: 30 days
Length of stay
Time frame: up to 24 months
Sepsis
Time frame: 30 days
Necrotizing enterocolitis
Time frame: 30 days
wound infections
Time frame: 30 days
wound dehiscence
Time frame: 30 days
parenteral nutrition
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
- Derived from this study: PubMed 42481630Blanco CL, Justice LB, Roddy D, Alimbetov D, Cooper DS, Hair AB; Cardiac Neonate Nutrition Study Group. A randomized trial of an exclusive human milk diet in neonates with single-ventricle physiology: 3 and 6 months follow-up outcomes. Pediatr Res. 2026 Jul 21. doi: 10.1038/s41390-026-05255-2. Online ahead of print.
- Derived from this study: PubMed 36528055Blanco 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.
- Individual participant dataSharing planned: No. It is a blinded study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cynthia Blanco, MD principal investigator
The University of Texas Health Science Center at San Antonio
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Human Milk Derived Fortifier and Human/Bovine Milk in people with Congenital Heart Defect, run by The University of Texas Health Science Center at San Antonio at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
growth velocity (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02860702, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2023.