Back to resultsOutpatient Exclusive Human Milk Diet for Single Infant With Complex Congenital Heart Disease
Primary Purpose
Growth Delay
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prolacta
Sponsored by
About this trial
This is an interventional treatment trial for Growth Delay
Eligibility Criteria
Inclusion Criteria:
- Complex congenital heart disease in presence of poor linear and head circumference growth and unable to tolerate cow's milk protein
Exclusion Criteria:
- n/a
Sites / Locations
- Dell Medical School
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Observational Case
Arm Description
1 infant will be enrolled as an observational case. Will receive an exclusive human milk diet at home.
Outcomes
Primary Outcome Measures
Growth
Weight velocity
Secondary Outcome Measures
Linear growth
Length gain
Head circumference growth
Head circumference growth
Full Information
NCT ID
NCT04231630
First Posted
January 9, 2020
Last Updated
January 13, 2020
Sponsor
University of Texas at Austin
Collaborators
Prolacta Bioscience
1. Study Identification
Unique Protocol Identification Number
NCT04231630
Brief Title
Outpatient Exclusive Human Milk Diet for Single Infant With Complex Congenital Heart Disease
Official Title
A Single Patient Observational Trial of an Exclusive Human Milk Diet to Provide and Evaluate Growth in a Single Infant at Home With Complex Congenital Heart Disease
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 20, 2019 (Actual)
Primary Completion Date
April 30, 2020 (Anticipated)
Study Completion Date
May 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas at Austin
Collaborators
Prolacta Bioscience
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A single patient observational trial to evaluate growth velocity and clinical outcomes of an infant status post cardiac surgery who has failed to grow well and demonstrated intolerance to cow milk-based and elemental formulas and fortifiers on a 100% human milk diet including a human milk based human milk fortifier formulated for term infants fluid restricted due to surgically correctable congenital conditions.
Detailed Description
A single patient observational study to evaluate growth velocity and clinical outcomes of an infant status post cardiac surgery who has failed to grow well and demonstrated intolerance to cow milk-based and elemental formulas and fortifiers on a 100% human milk diet. 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 this infant if fed an exclusive human milk diet will have improved growth in part due to data greater tolerability of the diet.
It is estimated that the study will require 90 days to complete. Growth in safety observations will be collected only during the time the patient is receiving the diet.
The primary objective is to evaluate growth velocity (weight velocity [g/kg/day] of a single infant receiving a 100% human milk diet including a human milk based human milk fortifier formulated for term infants who are fluid restricted due to surgically correctable congenital conditions. This will be compared to the infant's growth velocity prior to the initiation of said diet.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Growth Delay
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Observational Case
Arm Type
Other
Arm Description
1 infant will be enrolled as an observational case. Will receive an exclusive human milk diet at home.
Intervention Type
Other
Intervention Name(s)
Prolacta
Intervention Description
Will receive outpatient supplementation with donor human milk product added to mother's own milk
Primary Outcome Measure Information:
Title
Growth
Description
Weight velocity
Time Frame
through study completion, approximately 6 months
Secondary Outcome Measure Information:
Title
Linear growth
Description
Length gain
Time Frame
through study completion, approximately 6 months
Title
Head circumference growth
Description
Head circumference growth
Time Frame
through study completion, approximately 6 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Complex congenital heart disease in presence of poor linear and head circumference growth and unable to tolerate cow's milk protein
Exclusion Criteria:
n/a
Facility Information:
Facility Name
Dell Medical School
City
Austin
State/Province
Texas
ZIP/Postal Code
78715
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Outpatient Exclusive Human Milk Diet for Single Infant With Complex Congenital Heart Disease
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