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NCT05541536
Facilitating Learning Health Care (LHC) and Neonatal Research: Effects of a Brief Introductory Discussion Between a Neonatologist and the Parents of Eligible Infants
NA trial testing Consultation meeting in Understanding of Consent in Clinical Research in 100 participants. Completed in 5 October 2023.
5 October 2023
Quick facts
| Lead sponsor | The University of Texas Health Science Center, Houston |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | other |
| Enrollment | 100 |
| Start date | 1 September 2022 |
| Primary completion | 5 October 2023 |
| Estimated completion | 5 October 2023 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Consultation meeting
- Pamphlet
- Usual Care
Conditions studied
- Understanding of Consent in Clinical Research — all drugs for Understanding of Consent in Clinical Research →
- Implementation of Consent in Clinical Research — all drugs for Implementation of Consent in Clinical Research →
Sponsor
The University of Texas Health Science Center, Houston
Who can join
Eligibility, female only, with Understanding of Consent in Clinical Research or Implementation of Consent in Clinical Research. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The primary purpose of this pilot quality improvement study is to assess the impact of a brief introductory discussion about Learning Health Care (LHC) and clinical research between a neonatologist and the mothers (and the fathers, if present) of infants eligible for trials of the Neonatal Research Network (NRN) before they are approached for consent by clinical research coordinator (CRC) approach for NRN trial). Mothers will also be given a general information pamphlet addressing the same topic.
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 NCT05541536
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT05541536 (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 The University of Texas Health Science Center, Houston
- Last refreshed: 15 December 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/NCT05541536.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing