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NCT04977817
Probiotics/TPN in the NICU
trial testing Similac Probiotic Tri-Blend in Total Parenteral Nutrition in 150 participants. Completed in 26 August 2022.
1 August 2022
Quick facts
| Lead sponsor | Pediatrix |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 150 |
| Start date | 3 November 2021 |
| Primary completion | 1 August 2022 |
| Estimated completion | 26 August 2022 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- Similac Probiotic Tri-Blend
Conditions studied
- Total Parenteral Nutrition — all drugs for Total Parenteral Nutrition →
- Necrotizing Enterocolitis of Newborn — all drugs for Necrotizing Enterocolitis of Newborn →
Sponsor
Pediatrix — full company profile →
Who can join
Eligibility, any sex, with Total Parenteral Nutrition or Necrotizing Enterocolitis of Newborn. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to evaluate the effect of probiotic administration on TPN dependence in infants \< 32 weeks GA and BW 1500 grams or less in the Banner - University Medical Center Phoenix and Banner Children's at Desert Neonatal Intensive Care Units (NICU). The primary endpoint of capturing the number of days of TPN administration can reflect that an infant is progressing towards readiness for the initiation or advancement of enteral feedings at an earlier interval. The relationship between probiotic administration and the incidence of NEC, culture positive sepsis, and mortality is of interest to us and will be captured. Finally, the assessment of the tolerance of probiotic administration and the potential positive impact on growth and development in these premature infants may validate our current practices.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04977817
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Pediatrix trials
Trials by the same sponsor.
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- NCT04513691 — A Chart Review of Newborns With the Presence of Confirmed or Suspected Maternal Chorioamnionitis and Utilization of the · completed
- NCT04085978 — Effects of a Hypoglycemia Protocol With Glucose Gel on Neonatal Intensive Care Unit (NICU) Admission · terminated
- NCT03946631 — GDM Post Partum Screening · terminated
- NCT03414671 — The Effect of Standardizing the Definition of a Clinically Significant Cardiopulmonary Event on Length of Stay · completed
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 NCT04977817 (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 Pediatrix
- Last refreshed: 29 August 2022
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/NCT04977817.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing