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

Growth Delay Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04231630
• Other study ID #: 2019-11-0001
• Status: Enrolling by invitation
• Phase: N/A
• Start date: November 20, 2019
• Est. completion date: May 30, 2020

Study information

• Verified date: January 2020
• Source: University of Texas at Austin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1
• Est. completion date: May 30, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 6 Months to 1 Year

Eligibility

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

Related Conditions & MeSH terms

• Growth Delay
• Heart Diseases

Intervention

Other:
• Prolacta
Will receive outpatient supplementation with donor human milk product added to mother's own milk

Locations

Country	Name	City	State
United States	Dell Medical School	Austin	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas at Austin	Prolacta Bioscience

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Growth	Weight velocity	through study completion, approximately 6 months
Secondary	Linear growth	Length gain	through study completion, approximately 6 months
Secondary	Head circumference growth	Head circumference growth	through study completion, approximately 6 months