Last reviewed · How we verify
NCT01204983: NICU
Quality Improvement Project - Evaluation of Current Standard of Care for Feeding Practices in the NICU
trial in Infant, Very Low Birth Weight in 150 participants. Completed in 31 December 2025.
31 December 2025
Quick facts
| Lead sponsor | Baylor College of Medicine |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 150 |
| Start date | 1 July 2010 |
| Primary completion | 31 December 2025 |
| Estimated completion | 31 December 2025 |
| Sites | 1 location across United States |
Conditions studied
- Infant, Very Low Birth Weight — all drugs for Infant, Very Low Birth Weight →
Sponsor
Baylor College of Medicine
Who can join
1 Day and older, any sex, with Infant, Very Low Birth Weight. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Human milk is associated with substantial benefits to infants' health and development, especially in premature infants. Some mothers are unable or unwilling to provide breast milk to their infant. The use of donor human milk as an alternative to cow milk in these infants has risen dramatically in the past year. However, there have been recent reports of hyperphosphatemia and hyponatremia associated with the consumption of donor human milk products. These electrolyte imbalances can lead to concerning symptoms, including headache, nausea, vomiting, altered mental status, coma, seizures, or heart failure. It is important to recognize and appropriately treat these electrolyte disturbances associated with donor human milk to avoid potential nutritional problems.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Human milk feeding supports adequate growth in infants ≤ 1250 grams birth weight.
Hair AB, Hawthorne KM, Chetta KE, Abrams SA. · · 2013 · cited 59× · PMID 24220185 · DOI 10.1186/1756-0500-6-459
Verify or expand the search:
- PubMed search for NCT01204983
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Baylor College of Medicine trials
Trials by the same sponsor.
- NCT07513194 — GPC3 CAR T Cells With IL-15 and IL-21 for Recurrent ATRT and CNS Rhabdoid Tumors (RADIANT) · Phase 1 · not yet recruiting
- NCT05855824 — Toddler Biomarker of Nutrition Study · NA · not yet recruiting
- NCT06738628 — Disposable Endoscope Platform in Third Space Endoscopic Procedures · not yet recruiting
- NCT06834997 — Dronabinol As an Adjunct for Reducing Pain (DARP)-Texas Children's Hospital · Phase 2 · withdrawn
- NCT07387614 — WEB-BASED SUPPORT PROGRAM FOR CAREGIVERS OF VETERANS WITH DEMENTIA DISCHARGED FROM SKILLED NURSING FACILITIES TO HOME · NA · not yet recruiting
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 NCT01204983 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Baylor College of Medicine
- Last refreshed: 29 January 2026
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/NCT01204983.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing