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NCT04231630

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

Status unknown NA Last updated 18 January 2020
What this trial tests

NA trial testing Prolacta in Growth Delay in 1 participant. Status unknown.

Timeline
20 November 2019
Primary endpoint
30 April 2020
30 May 2020

Quick facts

Lead sponsorUniversity of Texas at Austin
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment1
Start date20 November 2019
Primary completion30 April 2020
Estimated completion30 May 2020
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Texas at Austin

Who can join

Adults 6 Months to 1, male only, with Growth Delay. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Growth Delay

Currently open trials in the same condition.

Other University of Texas at Austin trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04231630.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing