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NCT04231630
Outpatient Exclusive Human Milk Diet for Single Infant With Complex Congenital Heart Disease
NA trial testing Prolacta in Growth Delay in 1 participant. Status unknown.
30 April 2020
Quick facts
| Lead sponsor | University of Texas at Austin |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 1 |
| Start date | 20 November 2019 |
| Primary completion | 30 April 2020 |
| Estimated completion | 30 May 2020 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Prolacta
Conditions studied
- Growth Delay — all drugs for Growth Delay →
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.
Verify or expand the search:
- PubMed search for NCT04231630
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Growth Delay
Currently open trials in the same condition.
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- NCT05990582 — The Alkmaar MLPTI Cohort Study: Outcomes at 9 Years · NA · active not recruiting
Other University of Texas at Austin trials
Trials by the same sponsor.
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- NCT07370311 — A Culturally Adapted Decision Aid Intervention to Support Chinese American Dementia Caregivers in Feeding-Related Decisi · NA · not yet recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04231630 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Texas at Austin
- Last refreshed: 18 January 2020
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