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.

Observational Centre Hospitalier Intercommunal Creteil · NCT06808997

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 typeObservational
Enrollment100 (estimated)
Ages1 Minute to 5 Months
SexAll
SponsorCentre Hospitalier Intercommunal Creteil Academic / other
Locations31 sites (Amiens and 30 other locations)
Trial IDNCT06808997 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

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions PreTerm NeonateExtubation ReadinessExtubation FailureRespiratory MorbidityBronchopulmonary DysplasiaMechanical Ventilationextremely preterm infantsextubation
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.