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

NCT06808997 | Recruiting

• 1 other identifier: CERAINE
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 31

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.

Conditions

PreTerm Neonate; Extubation Readiness; Extubation Failure; Respiratory Morbidity; Bronchopulmonary Dysplasia; Mechanical Ventilation

Keywords

extremely preterm infants; extubation; mechanical ventilation; bronchopulmonary dysplasia

Outcome Measures

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.

  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 (12)

• 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.

  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

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

  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

• 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)

  From the day of birth to 4 months of age.

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

  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..

• The cumulative duration of any respiratory support

  From the day of birth to the day of discharge from the hospital, 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)

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

Study Arms (1)

Extremely Low Gestational Age Newborns (elgans)

No intervention. unique group.

Eligibility Criteria

• Age: 1 Minute - 5 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• Gestational age \< 28 weeks of gestation
• Age at admission to the participating unit \<24 hours

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Intercommunal Creteil: lead

Study Sites (31)

CHU Amiens Sud

Amiens, 80054, France

COMPLETED

CH Cote Basque

Bayonne, 64109, France

COMPLETED

CHU De Besancon

Besançon, 25030, France

COMPLETED

Dr Jean-michel Roue

Brest, 26609, France

RECRUITING

Hopital Femme Mére Enfant - HFME

Bron, 69677, France

COMPLETED

Centre Hospitalier Public du Cotentin

Cherbourg-Octeville, 50102, France

COMPLETED

CH Estaing

Clermont-Ferrand, 63 003, France

COMPLETED

Chu Louis Mourier

Colombes, 92700, France

COMPLETED

CHIC

Créteil, 94000, France

COMPLETED

CHU Grenoble Alpes _site nord

Grenoble, 38700, France

COMPLETED

CHU Félix Guyon

La Réunion, 97405, France

COMPLETED

CHU Kremlin-Bicêtre

Le Kremlin-Bicêtre, 94270, France

COMPLETED

CH Le Mans

Le Mans, 72037, France

COMPLETED

CHU Lille

Lille, 75019, France

COMPLETED

HME Limoges

Limoges, 87042, France

COMPLETED

APHM_ Hôpital Nord

Marseille, 13915, France

COMPLETED

GHEF- Site de MEAUX

Meaux, 77104, France

COMPLETED

Chi Andre Gregoire

Montreuil, 93105, France

COMPLETED

GHRMSA-Hopital Emile Muller

Mulhouse, 68100, France

COMPLETED

CHU NICE

Nice, 06202, France

COMPLETED

Chu Nimes

Nîmes, 30000, France

COMPLETED

CH Orléans

Orléans, 45067, France

COMPLETED

CHU Robert Debre

Paris, 75019, France

COMPLETED

Chu Port Royal

Paris, 75679, France

COMPLETED

CHU Necker

Paris, 75743, France

COMPLETED

CHI Poissy - St Germain en LayE

Poissy, 78303, France

COMPLETED

CHU Reims

Reims, 51100, France

COMPLETED

CHU Rennes

Rennes, 35203, France

COMPLETED

CH General Delafontaine

Saint-Denis, 93205, France

COMPLETED

CH GHPSO

Senlis, 60300, France

COMPLETED

CH Troyes

Troyes, 10000, France

COMPLETED

Related Publications (1)

• Shalish W, Keszler M, Davis PG, Sant'Anna GM. Decision to extubate extremely preterm infants: art, science or gamble? Arch Dis Child Fetal Neonatal Ed. 2022 Jan;107(1):105-112. doi: 10.1136/archdischild-2020-321282. Epub 2021 Feb 24.

  PMID: 33627331 BACKGROUND

MeSH Terms

Conditions

Bronchopulmonary Dysplasia

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Laurence Caeymaex, M.D, Ph.D

CONTACT

0033664095607; laurence.caeymaex@gmail.com

Camille JUNG, MD PhD

CONTACT

0033157022268; camille.jung@chicreteil.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: February 5, 2025
• Study Start: February 17, 2025
• Primary Completion: January 5, 2026
• Study Completion: April 30, 2026
• Last Updated: March 12, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (31)