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

NCT04231630 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2020-01-18

No results posted yet for this study

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.

Conditions

  • Growth Delay

Interventions

OTHER

Prolacta

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

Sponsors & Collaborators

  • Prolacta Bioscience

    collaborator INDUSTRY

  • University of Texas at Austin

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Max Age
1 Year
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-20
Primary Completion
2020-04-30
Completion
2020-05-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04231630 on ClinicalTrials.gov