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

NCT ID: NCT04231630

Last Updated: 2020-01-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-20
• Study Completion Date: 2020-05-30

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.

Conditions

Growth Delay

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Observational Case

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

Group Type: OTHER

Prolacta

Intervention Type: OTHER

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

Interventions

Prolacta

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 1 Year
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Prolacta Bioscience

INDUSTRY

Sponsor Role: collaborator

University of Texas at Austin

OTHER

Sponsor Role: lead

Responsible Party

Steven Abrams

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Dell Medical School

Austin, Texas, United States

Countries

United States

Other Identifiers

2019-11-0001

Identifier Type: -

Identifier Source: org_study_id