NCT06808997 Prospective Multicentre Mixed Methods Study to Explore Extubation Practices and Respiratory Outcomes in Extremely Preterm Neonates.
| NCT ID | NCT06808997 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Intercommunal Creteil |
| Condition | PreTerm Neonate |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-02-17 |
| Primary Completion | 2026-01-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2025-02-17 with a primary completion date of 2026-01-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this observational study is to learn about neonatologists' perceptions of extubation readiness and extubation and reintubation practices in extremely preterm infants in the first 2 weeks of life using prospective qualitative and quantitative data. Actual extubation readiness is defined as successful extubation, defined as no reintubation in the 7 days following extubation. Key research questions are: How do clinicians assess extubation readiness in this population? Does this assessment correlate with actual extubation success? What factors (reasons, clinical status, ventilatory parameters) are associated with extubation readiness? Patients born before 28 weeks gestational age and admitted to the neonatal intensive care unit (NICU) within the first 24 hours are be included. The attending physician will complete a prospectively administered questionnaire with open-ended and multiple-choice questions to daily assess the decision and rationale for extubation or non-extubation of patients mechanically ventilated during the first 15 days of life. Patient characteristics, respiratory outcomes, and mortality will be recorded until the end of hospitalisation and/or definitive weaning from any ventilatory support or supplemental oxygen.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06808997 clinical trial?
This trial is open to participants of all sexes, aged 1 Minute or older, up to 5 Months, studying PreTerm Neonate. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06808997 currently recruiting?
Yes, NCT06808997 is actively recruiting participants. Contact the research team at laurence.caeymaex@gmail.com for enrollment information.
Where is the NCT06808997 trial being conducted?
This trial is being conducted at Amiens, France, Bayonne, France, Besançon, France, Brest, France and 11 additional locations.
Who is sponsoring the NCT06808997 clinical trial?
NCT06808997 is sponsored by Centre Hospitalier Intercommunal Creteil. The trial plans to enroll 100 participants.