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

Sponsor

University of Texas at Austin (Other)

Overall Status

Unknown status

CT.gov ID

NCT04231630

Collaborator

Prolacta Bioscience (Industry)

Enrollment

Location

Arm

6.3

Anticipated Duration (Months)

0.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Growth Delay	Other: Prolacta	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

1 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Nov 20, 2019

Anticipated Primary Completion Date :

Apr 30, 2020

Anticipated Study Completion Date :

May 30, 2020

Arms and Interventions

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

Arm

Intervention/Treatment

Other: Observational Case

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

Other: Prolacta

Will receive outpatient supplementation with donor human milk product added to mother's own milk

Outcome Measures

Primary Outcome Measures

Growth [through study completion, approximately 6 months]
Weight velocity

Secondary Outcome Measures

Linear growth [through study completion, approximately 6 months]
Length gain
Head circumference growth [through study completion, approximately 6 months]
Head circumference growth

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Months to 1 Year

Sexes Eligible for Study:

Male

Accepts 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:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dell Medical School	Austin	Texas	United States	78715

Sponsors and Collaborators

University of Texas at Austin
Prolacta Bioscience

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Steven Abrams, Professor, University of Texas at Austin

ClinicalTrials.gov Identifier:

NCT04231630

Other Study ID Numbers:

2019-11-0001

First Posted:

Jan 18, 2020

Last Update Posted:

Jan 18, 2020

Last Verified:

Jan 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Heart Diseases

Heart Defects, Congenital

Study Results

No Results Posted as of Jan 18, 2020