Outpatient Exclusive Human Milk Diet for Single Infant With Complex Congenital Heart Disease
- Conditions
- Growth Delay
- Interventions
- Other: Prolacta
- Registration Number
- NCT04231630
- Lead Sponsor
- University of Texas at Austin
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 1
- Complex congenital heart disease in presence of poor linear and head circumference growth and unable to tolerate cow's milk protein
- n/a
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Observational Case Prolacta 1 infant will be enrolled as an observational case. Will receive an exclusive human milk diet at home.
- Primary Outcome Measures
Name Time Method Growth through study completion, approximately 6 months Weight velocity
- Secondary Outcome Measures
Name Time Method Linear growth through study completion, approximately 6 months Length gain
Head circumference growth through study completion, approximately 6 months Head circumference growth
Trial Locations
- Locations (1)
Dell Medical School
🇺🇸Austin, Texas, United States