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NCT03512093: PretermBabies
Improving SCBU Care for Preterm Babies
trial testing Retrospective chart review in Preterm Infant in 36 participants. Completed in 31 March 2021.
16 March 2021
Quick facts
| Lead sponsor | University of Oxford |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 36 |
| Start date | 1 May 2018 |
| Primary completion | 16 March 2021 |
| Estimated completion | 31 March 2021 |
| Sites | 1 location across Thailand |
Drugs / interventions tested
- Retrospective chart review
- Focus Group Discussion (FGD) of the medical staff
- Interviews of mothers
Conditions studied
- Preterm Infant — all drugs for Preterm Infant →
- Preterm Birth — all drugs for Preterm Birth →
Sponsor
University of Oxford
Who can join
18 and older, any sex, with Preterm Infant or Preterm Birth. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Since 2008, preterm neonates are taking care of in a Special Baby Care Unit (SCBU). Those born less than 34 weeks of gestation are followed-up monthly for one year for monitoring their hematocrit level, growth and development. Medical chart reviews are useful to evaluate the burden of diseases, characterize care treatment patterns and clinical outcomes by patients' subgroups; ultimately it can help identifying gaps in care pathways thus improving quality of care and ultimately reducing mortality. Medical records of all preterm neonates hospitalized in the SCBU including those followed up during their first year of life are computerized. The investigators propose to review the clinical charts of the preterm neonates in regards to four main points of care a) feeding, b) infections including early onset of neonatal sepsis, necrotizing enterocolitis and umbilical cord infection, c) body temperature control and d) respiratory distress. This medical charts review will be complemented by i) focus group discussions (FGD) with the medical staff working in the SCBU on the benefits and difficulties in using the existing guidelines for preterm care and by ii) interviews with mothers who delivered a preterm neonate on their experience in caring for their child and the challenges they faced. While performing the retrospective part of the project and after discussing the preliminary findings from the medical staff perception of the existing guidelines, the investigators will evaluate the feasibility to implement some additional recommendations to improve preterm birth outcomes based on recent literature and new protocols for resource-limited settings.
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 NCT03512093
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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 NCT03512093 (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 Oxford
- Last refreshed: 9 January 2023
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/NCT03512093.
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