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NCT04497740: FRONWT
Follow-up Results of Newborns With Tracheostomy
trial in Premature in 80 participants. Status unknown.
31 December 2020
Quick facts
| Lead sponsor | Hacettepe University |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 80 |
| Start date | 10 August 2020 |
| Primary completion | 31 December 2020 |
| Estimated completion | 31 December 2020 |
| Sites | 1 location across Turkey (Türkiye) |
Conditions studied
- Premature — all drugs for Premature →
- Tracheostomy Complication — all drugs for Tracheostomy Complication →
- Bronchopulmonary Dysplasia — all drugs for Bronchopulmonary Dysplasia →
Sponsor
Hacettepe University
Who can join
Under 15, any sex, with Premature or Tracheostomy Complication. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The chances of survival in premature babies, especially in babies born under 28 weeks, have increased in recent years, and comorbidities also increase. Bronchopulmonary dysplasia (BPD), one of the premature problems, is one of them. After a while, babies with heavy BPD are discharged with the support of a home-type mechanical ventilator by opening a tracheostomy. Tracheostomy procedure is performed by specialist doctors of otolaryngology under general anesthesia in the operating room conditions in newborns. Complications of this procedure such as bleeding, skin necrosis, decanulation, trachea laceration and infection in the early period can be seen. In the long term, in addition to complications such as formation of tracheal granulation tissue, ulceration, laceration due to the procedure, babies with tracheostomy may develop nutrition and speech problems and neurodevelopmental problems. In the literature, there is no comprehensive clinical follow-up study involving early and late clinical results related to newborns undergoing tracheostomy. In this study, early and late follow-up results (indications, anthropometric measurements, mechanical ventilation and oxygen deposition times, complications, tracheostomy closure times, tracheostomy closure times, neurodevelopmental patients in the Neonatal Intensive Care Unit of Hacettepe University Ihsan Dogramaci Children's Hospital. results, accompanying other comorbidities, etc.).
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Outcomes of newborns with tracheostomy: single center experience.
Tandırcıoğlu ÜA, Doğan Ö, Günaydın RÖ, Yiğit Ş, et al · · 2023 · PMID 37661670 · DOI 10.24953/turkjped.2023.185
Verify or expand the search:
- PubMed search for NCT04497740
- 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 NCT04497740 (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 Hacettepe University
- Last refreshed: 6 August 2020
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/NCT04497740.
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