Last reviewed · How we verify
NCT05838690: OPTION SAFE
Optimizing Tracheal Intubation Outcomes and Neonatal Safety
NA trial testing Personalized Intubation Safety (PINS) Bundle in Infant in 3,000 participants. Currently enrolling.
30 June 2027
Quick facts
| Lead sponsor | Children's Hospital of Philadelphia |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 3,000 |
| Start date | 1 April 2023 |
| Primary completion | 30 June 2027 |
| Estimated completion | 31 December 2027 |
| Sites | 8 locations across Canada, United States |
Drugs / interventions tested
- Personalized Intubation Safety (PINS) Bundle
Conditions studied
- Infant — all drugs for Infant →
- Intubation Complication — all drugs for Intubation Complication →
Sponsor
Children's Hospital of Philadelphia
Who can join
Under 1, any sex, with Infant or Intubation Complication. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of the study is to assess the impact of a personalized intubation planning tool, the Personalized INtubation Safety (PINS) Bundle on intubation procedural safety and clinical outcomes among patients intubated in the neonatal intensive care unit (NICU) setting.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05838690
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Children's Hospital of Philadelphia trials
Trials by the same sponsor.
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- NCT06693752 — CEUS Evaluation of Hydrocephalus in Neonates and Infants · Phase 2 · recruiting
- NCT07425691 — SPACE for Youth With Chronic Pain · recruiting
- NCT07444528 — Upper Airway Ultrasound to Predict Difficult Laryngoscopy in Neonates and Infants · enrolling by invitation
- NCT07321327 — Implementation Strategies for Caregiver and Teacher Use of Behavioral Interventions: Aim 2 · NA · enrolling by invitation
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 NCT05838690 (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 Children's Hospital of Philadelphia
- Last refreshed: 4 March 2026
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/NCT05838690.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing