Outpatient Exclusive Human Milk Diet for Single Infant With Complex Congenital Heart Disease

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Growth Delay

Intervention / Treatment
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* Other: Prolacta


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 1 Year

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Observational Case<br>1 infant will be enrolled as an observational case. Will receive an exclusive human milk diet at home. | Other: Prolacta<br>* Will receive outpatient supplementation with donor human milk product added to mother's own milk<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Growth | Weight velocity | through study completion, approximately 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Linear growth | Length gain | through study completion, approximately 6 months | 
| Head circumference growth | Head circumference growth | through study completion, approximately 6 months |