Extubation practices and breathing outcomes for babies born before 28 weeks' gestation
Criteria and Reasons for Extubation and Non-extubation in Preterm Infants: A Mixed Methods Study Prospectively Exploring Extubation and Reintubation Practices in Extremely Preterm Infants, and Associated Respiratory Outcomes.
The study will see if how doctors decide to remove breathing tubes in babies born before 28 weeks predicts who stays off the ventilator for at least a week.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 1 Minute to 5 Months |
| Sex | All |
| Sponsor | Centre Hospitalier Intercommunal Creteil Academic / other |
| Locations | 31 sites (Amiens and 30 other locations) |
| Trial ID | NCT06808997 on ClinicalTrials.gov |
What this trial studies
This multicentre, prospective mixed-methods study collects daily qualitative and quantitative data from attending neonatologists about decisions to extubate extremely preterm infants. Providers complete a structured questionnaire with open-ended and multiple-choice items to record their rationale, the infant's clinical status, and ventilator settings around extubation decisions. Extubation success is defined as no reintubation within 7 days, and the study links clinician judgments to actual respiratory outcomes. Infants born before 28 weeks and admitted to participating NICUs within 24 hours of life are enrolled, excluding those with parental refusal or participation in overlapping interventional protocols.
Who should consider this trial
Good fit: Babies born before 28 weeks' gestation who are admitted to a participating NICU within 24 hours of birth and whose parents consent to clinical data collection are eligible.
Not a fit: Infants whose parents refuse data collection or who are already enrolled in other interventional ventilation protocols will not be included and are unlikely to gain direct benefit from this observational effort.
Why it matters
Potential benefit: If successful, this could help clinicians time extubation better, reduce time on mechanical ventilation, and lower respiratory complications in extremely preterm infants.
How similar studies have performed: Previous cohort studies have documented high extubation failure rates and associations between prolonged ventilation and worse outcomes, but prospective mixed-methods work directly linking clinicians' readiness judgments to extubation success is relatively limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Gestational age \< 28 weeks of gestation * Age at admission to the participating unit \<24 hours Exclusion Criteria: * Parental opposition to their infant's clinical data collection * Participation in a research protocol with potential impact on extubation and/or duration of mechanical ventilation
Where this trial is running
Amiens and 30 other locations
- CHU Amiens Sud — Amiens, France (Completed)
- CH Cote Basque — Bayonne, France (Completed)
- CHU De Besancon — Besançon, France (Completed)
- Dr Jean-michel Roue — Brest, France (Recruiting)
- Hopital Femme Mére Enfant - HFME — Bron, France (Completed)
- Centre Hospitalier Public du Cotentin — Cherbourg-Octeville, France (Completed)
- CH Estaing — Clermont-Ferrand, France (Completed)
- Chu Louis Mourier — Colombes, France (Completed)
- Chic — Créteil, France (Completed)
- CHU Grenoble Alpes _site nord — Grenoble, France (Completed)
- CHU Félix Guyon — La Réunion, France (Completed)
- CHU Kremlin-Bicêtre — Le Kremlin-Bicêtre, France (Completed)
- CH Le Mans — Le Mans, France (Completed)
- CHU Lille — Lille, France (Completed)
- HME Limoges — Limoges, France (Completed)
- APHM_ Hôpital Nord — Marseille, France (Completed)
- GHEF- Site de MEAUX — Meaux, France (Completed)
- Chi Andre Gregoire — Montreuil, France (Completed)
- GHRMSA-Hopital Emile Muller — Mulhouse, France (Completed)
- Chu Nice — Nice, France (Completed)
- Chu Nimes — Nîmes, France (Completed)
- CH Orléans — Orléans, France (Completed)
- CHU Robert Debre — Paris, France (Completed)
- Chu Port Royal — Paris, France (Completed)
- CHU Necker — Paris, France (Completed)
- CHI Poissy - St Germain en LayE — Poissy, France (Completed)
- CHU Reims — Reims, France (Completed)
- CHU Rennes — Rennes, France (Completed)
- CH General Delafontaine — Saint-Denis, France (Completed)
- Ch Ghpso — Senlis, France (Completed)
- CH Troyes — Troyes, France (Completed)
Study contacts
- Study coordinator: Laurence Caeymaex, M.D, Ph.D
- Email: laurence.caeymaex@gmail.com
- Phone: 0033664095607
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.