Last reviewed · How we verify
NCT03085329
A Study to Evaluate the Efficacy of Seattle-PAP for the Respiratory Support of Premature Infants
NA trial testing Seattle-PAP in Premature Birth in 220 participants. Status unknown.
31 October 2018
Quick facts
| Lead sponsor | Seattle Children's Hospital |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 220 |
| Start date | 10 February 2017 |
| Primary completion | 31 October 2018 |
| Estimated completion | 9 February 2019 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Seattle-PAP
- Conventional bubble nasal CPAP
Conditions studied
- Premature Birth — all drugs for Premature Birth →
Sponsor
Seattle Children's Hospital
Who can join
Under 30 Weeks, any sex, with Premature Birth. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study is designed to test the hypothesis that among infants born at less than 30 weeks, weighing less than 1500 g at delivery, and receiving initial respiratory support non-invasively or on invasive respiratory support and meeting extubation criteria in the first 72 h of life, fewer neonates managed on Seattle--PAP will require endotracheal intubation and conventional mechanical ventilation (CMV) than will neonates managed from birth on bubble nasal continuous positive airway pressure (Bn-CPAP) using the Fischer- \& Paykel (FP) device. Neonates on nasal continuous positive airway pressure (CPAP) in the delivery room or who are stabilized on mechanical ventilation as their initial form of respiratory support and meet our criteria for extubation within 72 h of birth will be eligible for randomization and study. The primary endpoint of this study is the cumulative incidence of respiratory failure requiring intubation that occurs in patients after randomization and before 36 weeks post menstrual age (PMA) or discharge, whichever comes first. Presently, the literature supports that this age group typically exhibits intubation rates of 50% or more, which is consistent with the data from the Nationwide Children's Hospital/Ohio State University (NCH/OSU) Neonatal Intensive Care Unit (NICU).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03085329
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Premature Birth
Currently open trials in the same condition.
- NCT07490912 — Neonatal Data and Biobank to Study Factors Influencing Development in Preterm Infants Born at <32 Weeks' Gestation and/o · recruiting
- NCT07183462 — Azithromycin and Ampicillin for Late PPROM · Phase 4 · recruiting
- NCT07306793 — The Effect of PIOMI and Chronobiological Nutrition on Readiness for Feeding, Full Transition to Oral Feeding and Body We · NA · recruiting
- NCT06554522 — Pragmatic Evaluation of Respiratory Distress Syndrome Treatment in Africa · Phase 4 · recruiting
- NCT06340971 — Air Pollution and Pregnancy · recruiting
Other Seattle Children's Hospital trials
Trials by the same sponsor.
- NCT07522112 — Evaluating a Shared Decision-making Intervention for Families About Firearm Storage · NA · not yet recruiting
- NCT06864611 — Evaluating Huddles as a Novel Approach to Improving Concussion Safety · NA · not yet recruiting
- NCT07424157 — Long-Term Follow-Up of Subjects Treated With Seattle Children's Therapeutics Gene Therapy Products · not yet recruiting
- NCT07148050 — Immunotherapy for Solid Tumor Malignancies in Pediatrics Using Interleukin-15 and -21 Armored Glypican-3-specific Chimer · Phase 1 · recruiting
- NCT07097792 — Concussion Recovery and Support Program · NA · recruiting
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 NCT03085329 (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 Seattle Children's Hospital
- Last refreshed: 22 March 2017
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/NCT03085329.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing