PreTerm NeonateCERAINENCT06808997
Prospective Multicentre Mixed Methods Study to Explore Extubation Practices and Respiratory Outcomes in Extremely Preterm Neonates.
An observational study of PreTerm Neonate and Extubation Readiness, run by Centre Hospitalier Intercommunal Creteil at 31 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 minute to 5 months
- Conditions the study is for
- PreTerm Neonate, Extubation Readiness, Extubation Failure
- How many people
- 166 participants
- Where
- 31 sitesFrance
- Study dates
- 17 Feb 2025to 14 May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 minute to 5 months
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- Gestational age < 28 weeks of gestation
- Age at admission to the participating unit <24 hours
Who cannot join
- 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 locations and contacts
31 sites in 1 country.
31 sites in 1 country
France31 sites
CHU Amiens Sud
Amiens, 80054
CH Cote Basque
Bayonne, 64109
CHU De Besancon
Besançon, 25030
Dr Jean-michel Roue
Brest, 26609
Hopital Femme Mére Enfant - HFME
Bron, 69677
Centre Hospitalier Public du Cotentin
Cherbourg-Octeville, 50102
CH Estaing
Clermont-Ferrand, 63 003
Chu Louis Mourier
Colombes, 92700
CHIC
Créteil, 94000
CHU Grenoble Alpes _site nord
Grenoble, 38700
CHU Félix Guyon
La Réunion, 97405
CHU Kremlin-Bicêtre
Le Kremlin-Bicêtre, 94270
CH Le Mans
Le Mans, 72037
CHU Lille
Lille, 75019
HME Limoges
Limoges, 87042
APHM_ Hôpital Nord
Marseille, 13915
GHEF- Site de MEAUX
Meaux, 77104
Chi Andre Gregoire
Montreuil, 93105
GHRMSA-Hopital Emile Muller
Mulhouse, 68100
CHU NICE
Nice, 06202
Chu Nimes
Nîmes, 30000
CH Orléans
Orléans, 45067
CHU Robert Debre
Paris, 75019
Chu Port Royal
Paris, 75679
CHU Necker
Paris, 75743
CHI Poissy - St Germain en LayE
Poissy, 78303
CHU Reims
Reims, 51100
CHU Rennes
Rennes, 35203
CH General Delafontaine
Saint-Denis, 93205
CH GHPSO
Senlis, 60300
CH Troyes
Troyes, 10000
About this study
Official title: 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 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.
Read the detailed description
With prolonged stays in the neonatal intensive care unit (NICU) and significant respiratory morbidity, respiratory management of the most premature newborns - born before 28 weeks gestational age (GA) - brings a number of challenges. Despite recommendations to give priority to non-invasive ventilation in cases of respiratory insufficiency, recent studies show that over 80% of these newborns receive mechanical ventilation (MV) at least once in their NICU course, most within the first week of life (100% if born at 23 SA, >90% at 24 and 25 SA, >80% at 26 and >70% at 27 weeks GA). Several studies have shown that a longer cumulative duration of MV is associated with a worse respiratory and neurodevelopmental prognosis in this population.
Early extubation is therefore recommended. However, extubation failures in patients born at these early stages of life are common and are per se associated with respiratory morbidity. Extubation failure is defined in the literature as reintubation within days of extubation.
A delay of 7 days after extubation has been identified as the time frame for capturing extubations related to respiratory causes. In a French study, using the SEPREVEN cohort for patients born before 27 weeks' GA, extubation failure at 3, 7 and 15 days concerned 25%, 33% and 50% of patients respectively. The decision to extubate a premature patient is a complex one, but contributes in part to the patient's outcome.
Shalish referred to the concept of "extubation readiness dilemma" to indicate the uncertainty surrounding the clinical features associated with successful extubation. Identifying a state for each patient that allows successful extubation, without reintubation in the following days, is most often based on ward routines in which assessments of the infant's respiratory capacity are taken into account. Medical literature doesn't provide recommendations on extubation criteria, and practices differ from one unit to another.
The aim of this study is to provide a detailed description of extubation practices and failures in several NICUs in France, based on a prospective collection of qualitative and mixed data.
- Conditions
- PreTerm Neonate, Extubation Readiness, Extubation Failure, Respiratory Morbidity, Bronchopulmonary Dysplasia, Mechanical Ventilation
- Keywords
- extremely preterm infants, extubation, mechanical ventilation, bronchopulmonary dysplasia
- Medical subject headings
- Bronchopulmonary Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Extremely Low Gestational Age Newborns (elgans) | No intervention. unique group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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,
Measured: 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.
Occurrence of Extubation failure defined as reintubation in the 7 days after an extubation.
Measured: 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)
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)
Measured: From the day of birth to 4 months of age.
Cumulative duration of mechanical ventilation (MV) during the NICU stay.
Sum of the days of mechanical ventilation during the NICU stay, collected prospectively.
Measured: 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
The cumulative duration of positive pressure Non-Invasive Ventilation (PPNIV) and High Flow Nasal Ventilation (HFNV), Low Flow Nasal Ventilation (LFNV) during the entire hospital stay
Measured: From the day of birth to the day of discharge from the hospital, up to maximum 4 months of age.
Duration of Mechanical Ventilation and Positive Pressure Non-Invasive Ventilation
Sum of the days of Mechanical Ventilation or positive pressure non invasive ventilation during the entire hospital stay
Measured: From the day of birth to the day of discharge from the hospital, up to 4 months of age
Bronchopulmonary dysplasia at 36 weeks corrected Gestational Age
Bronchopulmonary dysplasia at 36 weeks corrected Gestational age defined as need for any type of ventilation (invasive or non-invasive) or low flow oxygen therapy at 36 weeks gestational age.
Measured: At 36 weeks corrected gestational age
Mortality
Mortality before discharge from the hospital
Measured: From the day of birth to the day of discharge from the hospital, maximum 5 months of age
Length of stay in the Neonatal Intensive Care Unit (NICU)
Length of stay in the NICU
Measured: From the day of birth to the day of discharge from the NICU, maximum 4 months of life
Factors involved in the perception of "too altered respiratory condition to be extubated"
Description of the reasons related to the respiratory system, clinical respiratory conditions (e;g. apneas ....) and ventilatory settings (pressure, oxygen, ...) reported by the physician associated with a reported "too altered respiratory condition to be extubated" condition.
Measured: From the day of birth to day 15 of life during the period on Mechanical Ventilation
Clinician-reported Prognosis of extubation succes
Physician-reported prognosis of extubation based on a 4 points scale (from 1 "unconfident" to 4 "very confident")
Measured: From day of birth to day 15 of life during the period on Mechanical Ventilation
Description of complications of intubation
Description of a multiple choice of complications after each intubation :
No complication, oropharyngeal lesion, cardiorespiratory arrest, severe intraventricular haemorraghe, contribution to patient's death.
Measured: from the day birth to the day discharge from the NICU, up to maximum 4 months of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start17 Feb 2025
- Primary completion5 Jan 2026
- Study completion14 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PreTerm NeonateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal Creteil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06808997
- Sponsor's protocol ID
- CERAINE
- Acronym
- CERAINE
- Status last verified
- Dec 2025
- First submitted
- 13 Jan 2025
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33627331
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06808997
- Acronym / sponsor ID
- CERAINE / CERAINE
- Conditions
- PreTerm Neonate, Extubation Readiness, Extubation Failure, Respiratory Morbidity, Bronchopulmonary Dysplasia, Mechanical Ventilation
- Keywords
- extremely preterm infants, extubation, mechanical ventilation, bronchopulmonary dysplasia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal CreteilUniversity, hospital or other
- Study start
- 17 Feb 2025 (actual)
- Primary completion
- 5 Jan 2026 (actual)
- Study completion
- 14 May 2026 (actual)
- First posted
- 5 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
With prolonged stays in the neonatal intensive care unit (NICU) and significant respiratory morbidity, respiratory management of the most premature newborns - born before 28 weeks gestational age (GA) - brings a number of challenges. Despite recommendations to give priority to non-invasive ventilation in cases of respiratory insufficiency, recent studies show that over 80% of these newborns receive mechanical ventilation (MV) at least once in their NICU course, most within the first week of life (100% if born at 23 SA, >90% at 24 and 25 SA, >80% at 26 and >70% at 27 weeks GA). Several studies have shown that a longer cumulative duration of MV is associated with a worse respiratory and neurodevelopmental prognosis in this population.
Early extubation is therefore recommended. However, extubation failures in patients born at these early stages of life are common and are per se associated with respiratory morbidity. Extubation failure is defined in the literature as reintubation within days of extubation.
A delay of 7 days after extubation has been identified as the time frame for capturing extubations related to respiratory causes. In a French study, using the SEPREVEN cohort for patients born before 27 weeks' GA, extubation failure at 3, 7 and 15 days concerned 25%, 33% and 50% of patients respectively. The decision to extubate a premature patient is a complex one, but contributes in part to the patient's outcome.
Shalish referred to the concept of "extubation readiness dilemma" to indicate the uncertainty surrounding the clinical features associated with successful extubation. Identifying a state for each patient that allows successful extubation, without reintubation in the following days, is most often based on ward routines in which assessments of the infant's respiratory capacity are taken into account. Medical literature doesn't provide recommendations on extubation criteria, and practices differ from one unit to another.
The aim of this study is to provide a detailed description of extubation practices and failures in several NICUs in France, based on a prospective collection of qualitative and mixed data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Extremely Low Gestational Age Newborns (elgans) | – | –No intervention. unique group. |
Who may qualify
- Ages
- 1 minute to 5 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (2 listed)
- Gestational age < 28 weeks of gestation
- Age at admission to the participating unit <24 hours
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Reasons for non-extubation in case of MV in patients born before 28 wks GA in the first 15 days of life,
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)
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.
12 secondary outcomes
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.
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
Occurrence of Extubation failure in ELGANs on Mechanical ventilation within the first 15 days of life.
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
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.
Cumulative duration of mechanical ventilation (MV) during the NICU stay.
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..
The cumulative duration of any respiratory support
Time frame: From the day of birth to the day of discharge from the hospital, up to maximum 4 months of age.
Duration of Mechanical Ventilation and Positive Pressure Non-Invasive Ventilation
Time frame: From the day of birth to the day of discharge from the hospital, up to 4 months of age
Bronchopulmonary dysplasia at 36 weeks corrected Gestational Age
Time frame: At 36 weeks corrected gestational age
Mortality
Time frame: From the day of birth to the day of discharge from the hospital, maximum 5 months of age
Length of stay in the Neonatal Intensive Care Unit (NICU)
Time frame: From the day of birth to the day of discharge from the NICU, maximum 4 months of life
Factors involved in the perception of "too altered respiratory condition to be extubated"
Time frame: From the day of birth to day 15 of life during the period on Mechanical Ventilation
Clinician-reported Prognosis of extubation succes
Time frame: From day of birth to day 15 of life during the period on Mechanical Ventilation
Description of complications of intubation
Time frame: from the day birth to the day discharge from the NICU, up to maximum 4 months of life
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Background: PubMed 33627331Shalish 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PreTerm Neonate and Extubation Readiness, run by Centre Hospitalier Intercommunal Creteil at 31 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reasons for non-extubation in case of MV in patients born before 28 wks GA in the first 15 days of life, (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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06808997, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.