Prospective Multicentre Mixed Methods Study to Explore Extubation Practices and Respiratory Outcomes in Extremely Preterm Neonates.

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-5
SponsorCentre Hospitalier Intercommunal Creteil

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Gestational age < 28 weeks of gestation

Age at admission to the participating unit <24 hours

Disqualifiers

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

Trial population

Participation in the study is proposed to type 3 neonatal intensive care units in France. Extremely premature newborns born before 28 weeks gestation in the participating units will be included.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

100 Participants
are grouped into 1 trial group
Group A: Extremely Low Gestational Age Newborns (elgans)

Trial outcomes

Primary outcomes

1

Reasons for non-extubation in case of MV in patients born before 28 wks GA in the first 15 days of life,

For each included patient who is intubated and mechanically ventilated during a period within his first 15 days of life, the reasons for non-extubation. These are the reasons reported by the physician by answering a qualitative questionnaire with an open-ended question, and preexistent possible multiple choices.

Time frame
On a 12 hours basis from Day 0 to Day 2 of life, and on a dialy basis from Day 2 to Day 15 of life (according to the period the patient is on Mechanical Ventilation)

Secondary outcomes

1

Reported perceived extubation readiness in Extremely Low Gestational Age Neonates (ELGANs) born before 28weeks gestation and mechanically ventilated in a period within the first 15 days of life.

Reported perceived extubation readiness in ELGANs born before 28weeks gestation and mechanically ventilated in a period within the first 15 days of life, defined as Reasons for extubation and ventilatory and clinical data,

Time frame
These data will be collected in case of Mechanical Ventilation every 48 hours between the Birthday and Day 2 of life and then every morning between Day 2 and Day 15 of life
2

Occurrence of Extubation failure in ELGANs on Mechanical ventilation within the first 15 days of life.

Occurrence of Extubation failure defined as reintubation in the 7 days after an extubation.

Time frame
These data will be collected in case of Mechanical Ventilation every 48 hours between the Birthday and Day 2 of life and then every morning between Day 2 and Day 15 of life
3

Corrected gestational age on definitive discontinuation of MV, of Positive Pressure Non-Invasive Ventilation (NIV), of High Flow Nasal Cannula (HFNC) ventilation) and Low Flow Nasal Cannula Ventilation (LFNNC)

Corrected gestational age on definitive discontinuation of MV, of Positive Pressure Non-Invasive Ventilation (NIV), of High Flow Nasal Cannula (HFNC) ventilation) and Low Flow Nasal Cannula Ventilation (LFNNC)

Time frame
From the day of birth to 4 months of age.
4

Cumulative duration of mechanical ventilation (MV) during the NICU stay.

Sum of the days of mechanical ventilation during the NICU stay, collected prospectively.

Time frame
These data will be collected from the day of birth to the day of discharge from the NICU, up to maximum 4 months of age..

Other outcomes

1

Description of unit practices (mechanical ventilation weaning protocol and/or extubation criteria in standard care)

Description of unit practices (use of a Mechanical Ventilation weaning protocol and/or the use of extubation criteria in standard care)

Time frame
From the date of enrollment to the date of the end of the inclusions, which means one year.

Sponsors and contacts

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