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

The University of Texas System (UT)

Status: Unknown

Conditions: Growth Delay

Treatments: Other: Prolacta

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04231630

2019-11-0001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1 patient

Sex: Male

Ages: 6 months to 1 year old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

1 participants in 1 patient group

Observational Case

Other group

Description:

1 infant will be enrolled as an observational case. Will receive an exclusive human milk diet at home.

Treatment:

Other: Prolacta