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NCT05385939
Gastric Bacterial Colonization of Preterm Neonates
trial testing Observational in Microbial Colonization in 122 participants. Completed in 1 May 2022.
31 October 2021
Quick facts
| Lead sponsor | Christiana Care Health Services |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 122 |
| Start date | 1 April 2019 |
| Primary completion | 31 October 2021 |
| Estimated completion | 1 May 2022 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Observational — full drug profile →
Conditions studied
- Microbial Colonization — all drugs for Microbial Colonization →
- Preterm Birth — all drugs for Preterm Birth →
Sponsor
Christiana Care Health Services — full company profile →
Who can join
Adults 1 Week to 6 Months, any sex, with Microbial Colonization or Preterm Birth. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This prospective cohort study was conducted in the Christiana Care Health System Neonatal Intensive Care Unit. It occurred at two time periods: Time period 1 included infants admitted to the traditional, open bay NICU. Time period 2 included infants admitted to the new private, single family room NICU. There was a 3 month period between Time period 1 and Time period 2 to ensure that there was no patient overlap. Stool samples and environmental samples were collected at 1 and 4 weeks after birth in both time periods. The objective of this study was to establish the gastrointestinal microbiome of infants born at less than 32 weeks gestation admitted to the exiting open bay NICU and compare it to the gastrointestinal microbiome of infants born at less than 32 weeks admitted to the new private, single family room NICU.
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 NCT05385939
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Trials by the same sponsor.
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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 NCT05385939 (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 Christiana Care Health Services
- Last refreshed: 23 May 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/NCT05385939.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing