Last reviewed · How we verify
NCT05471336
Enteral Feeding and Splanchnic NIRS Values in Infants With Neonatal Encephalopathy (NE)
NA trial testing Enteral Feeding in Neonatal Encephalopathy in 40 participants. Completed in 14 March 2024.
7 February 2024
Quick facts
| Lead sponsor | NYU Langone Health |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 40 |
| Start date | 9 September 2022 |
| Primary completion | 7 February 2024 |
| Estimated completion | 14 March 2024 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Enteral Feeding — full drug profile →
Conditions studied
- Neonatal Encephalopathy — all drugs for Neonatal Encephalopathy →
Sponsor
NYU Langone Health — full company profile →
Who can join
Adults 0 Days to 2 Days, any sex, with Neonatal Encephalopathy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The research team plans to administer trophic enteral feeds to infants with Neonatal Encephalopathy that are undergoing therapeutic hypothermia. The team will monitor splanchnic NIRS values and compare these values to a group of historic infants who underwent hypothermia but did not receive feeds, to investigate whether there may be a range of values that can predict safe feeding. The team will also look at some clinical outcomes including feeding tolerance, time to achieve full enteral feeds, infection rates, length of hospital stay.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
A prospective study describing splanchnic NIRS and clinical outcomes in encephalopathic neonates receiving minimal enteral nutrition during therapeutic hypothermia.
Nuzum TA, Bailey SM, Caprio M, Wachtel EV. · · 2025 · PMID 40210989 · DOI 10.1038/s41372-025-02270-9
Verify or expand the search:
- PubMed search for NCT05471336
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Enteral Feeding
Trials testing the same drug.
- NCT06156189 — Prevalence of Enteral Nutrition Interruption in an Oncology Intensive Care Unit. · completed
Other recruiting trials for Neonatal Encephalopathy
Currently open trials in the same condition.
- NCT06747260 — Feasibility and Safety of Intranasally Administered Breast Milk in HIE · EARLY_PHASE1 · recruiting
- NCT05889507 — Cooling in Mild Encephalopathy · Phase 3 · recruiting
- NCT05848271 — Natural History Study of Patients with HPDL Mutations · recruiting
- NCT05610085 — A Dose Escalation Study of Levetiracetam in the Treatment of Neonatal Seizures · Phase 2 · recruiting
- NCT04603547 — Transcutaneous Carbon Dioxide Monitoring in Neonates Receiving Therapeutic Hypothermia for Neonatal Encephalopathy · active not recruiting
Other NYU Langone Health trials
Trials by the same sponsor.
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- NCT05558267 — Potassium Containing Salt-Substitute in Hemodialysis-Dependent End Stage Kidney Disease · NA · not yet recruiting
- NCT06637852 — Sexual and Urinary Function Improvement for Cancer Survivors · NA · not yet recruiting
- NCT06236087 — Overdose Prevention Centers and Behavioral Health · not yet recruiting
- NCT06462027 — Packed Red Blood Cell Transfusion During Cardiac Arrest · Phase 1 · suspended
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 NCT05471336 (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 NYU Langone Health
- Last refreshed: 2 May 2024
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/NCT05471336.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing