Neonatal Respiratory FailureNCT05081973
A Model for Predicting Extubation Success in Premature Babies
An observational study of Neonatal Respiratory Failure and Invasive Mechanical Ventilation, run by Marmara University at 2 sites in Turkey (Türkiye).
Trial summary
Invasive mechanical ventilation is a life-saving treatment in critically ill newborns with respiratory failure. However, continuing this treatment for a long time may have negative consequences, especially bronchopulmonary dysplasia (BPD) secondary to mechanotrauma. Read more about this study
- Who is it for?
- Ages 48 hours to 60 days
- Conditions the study is for
- Neonatal Respiratory Failure, Invasive Mechanical Ventilation, Extubation Failure
- What is being tested?
- A model for predicting extubation success based on extubation readiness estimator and lung ultrasonography score
- How many people
- 114 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 20 Apr 2021to 20 Apr 2024
- 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 48 hours to 60 days
- All sexes
- No healthy volunteers
- Child
Study population: All premature infants with planned extubation during the study period.
Who may be able to join
- Birth weight <1250 gr
- Being intubated within the first 7 days of life and then followed on mechanical ventilation
- Being intubated for at least 48 hours
- Not completing the postnatal 60 days
- Meeting conventional clinical extubation criteria
- Having planned extubation for the first time
Show all 11Show fewer
- Having no air leakage occurred
- Having no structural heart and lung disease
- Having no congenital and chromosomal anomalies
- Having an intact diaphragm
- Having no PVL, IVH (Grade 2 and above), HIE, meningitis or known CNS anomaly during extubation
Who cannot join
- Infants with a gestational age of 34 weeks or more
- Infants with unplanned and spontaneous extubation
- Infants who have tried extubation before
- Infants with hydrops fetalis
- Infants with chest deformities
- Infants with central respiratory failure (insufficient respiratory effort/control or continuous apneic)
Show all 14Show fewer
- Infants who are neurologically depressed and do not have spontaneous breathing (hypocarbia due to hyperventilation, presence of severe sedation, use of neuromuscular drugs)
- In the presence of genetic or congenital anomalies (esophageal atresia, severe diaphragmatic hernia, diaphragm paralysis)
- Having phrenic nerve damage
- Presence of congenital myopathy
- Having any air leakage
- Having structural heart and lung disease
- Having no intact diaphragm
- Having PVL, IVH (Grade 2 and above), HIE, meningitis or known CNS anomaly during extubation
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites, 1 recruiting
- Recruiting
Marmara University Pendik Training and Research Hospital
Istanbul, 34899
Aslı Memişoğlu, MD, acinarmemisoglu@gmail.com
Eren Ozek, Prof., ozekeren@gmail.com
- Active, not recruiting
Basaksehir Cam and Sakura City Hospital
Istanbul
About this study
Official title: A Model for Predicting Extubation Success Based on the "Extubation Readiness Estimator" and Lung Ultrasonography Score in Premature Babies
Invasive mechanical ventilation is a life-saving treatment in critically ill newborns with respiratory failure. However, continuing this treatment for a long time may have negative consequences, especially bronchopulmonary dysplasia (BPD) secondary to mechanotrauma. For this reason, it is essential to terminate the mechanical ventilation treatment at the most appropriate time.
About half of the extremely preterm babies may fail extubation even if the clinical criteria traditionally used for extubation are met. Unsuccessful extubation is associated with increased intraventricular bleeding, death, BPD, death or BPD, longer duration of ventilator support.
Read more
When respiratory failure and lung pathologies of extremely preterm babies begin to improve, the target for mechanical ventilation should be early and successful extubation. Currently, the decision to extubate a preterm baby is primarily based on clinical judgment. Only a few studies that showed the low predictive value and limited utility using different measures have evaluated readiness for extubation. Lung ultrasonography (USG) is a noninvasive bedside technique that has been found useful for predicting the success of weaning from the ventilator in adults; however, very little data are available in neonates. In a recently published study, it was proposed an extubation readiness estimation tool based on clinical and demographic data of preterm babies who were attempted elective extubation.
The researchers' hypothesis is that the use of a model based on extubation success scoring and lung USG scoring before extubation reduces the failure of the first extubation attempt in very low birth weight infants. The aim of the study is to evaluate the value of using an integrated model based on pre-extubation "extubation readiness predictor" and lung USG scoring to predict extubation success in preterm babies undergoing invasive mechanical ventilation.
Read the detailed description
Long-term invasive mechanical ventilation may have detrimental effects in preterm infants, although it is a life-saving treatment in critically ill newborns with respiratory failure. (e.g. bronchopulmonary dysplasia (BPD), superimposed bacterial infections and colonization, air leak, etc.). For this reason, it is essential to terminate the mechanical ventilation treatment at the most appropriate time.
A significant portion of the extremely preterm babies may fail extubation even if the clinical criteria traditionally used for extubation are met. Unsuccessful extubation is associated with increased intraventricular bleeding, death, BPD, death or BPD, longer duration of ventilator support.
When respiratory failure and lung pathologies of extremely preterm babies begin to improve, the target for mechanical ventilation should be early and successful extubation. Currently, the decision to extubate a preterm baby is primarily based on clinical judgment. Only a few studies that showed the low predictive value and limited utility using different measures have evaluated readiness for extubation. Lung ultrasonography (USG) is a noninvasive bedside technique that has been found useful for predicting the success of weaning from the ventilator in adults; however, very little data are available in neonates. In a recently published study, it was proposed an extubation readiness estimation tool based on clinical and demographic data of preterm babies who were attempted elective extubation.
The researchers' hypothesis is that the use of a model based on extubation success scoring and lung USG scoring before extubation; reduces the failure of the first extubation attempt in very low birth weight infants. The aim of the study is to evaluate the value of using a model based on pre-extubation "extubation readiness predictor" and lung USG scoring to predict extubation success in preterm babies undergoing invasive mechanical ventilation.
This study is a prospective observational study. The study is planned to be conducted in infants with a birth weight <1250 g, who were intubated within the first 7 days of life, remained intubated invasive conventional mechanical ventilation for at least 48 hours, did not complete the postnatal 60 days, and met the traditional extubation criteria of the institution and were considered for elective extubation for the first time.
An "informed consent form" will be obtained from the parents of the babies included in the study. The birth dates, protocol numbers, birth types, maternal histories, genders, weeks of gestation and birth weights of the babies will be recorded.
The usual institutional routine approaches will be applied after the baby is born.
- Being tested
- A model for predicting extubation success based on extubation readiness estimator and lung ultrasonography score
- Keywords
- Neonate, Extubation Failure, Lung Ultrasonography Score, Extubation Readiness Estimator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A model for predicting extubation success based on extubation readiness estimator and lung ultrasonography scoreOther
Parameters to be recorded before and after extubation to create a "new dual extubation model" from all babies who met the extubation criteria included in the study:
- "Lung ultrasound score": Lung ultrasound will be performed prior to the extubation and after the extubation. Lung aeration will be scored based on three chest areas for each side (upper anterior, lower anterior and lateral) and a score of 0 to 3 points will be given for each area (Total score ranges from 0 to 18 points).
- "Probability of Successful Extubation": It will be calculated by extubation readiness estimator provided by the website named http://extubation.net/.
This parameter will be calculated only 1 hour prior to the scheduled extubation time.
| Study group | Role | What they receive |
|---|---|---|
| Intubated preterm infants | Infants with a birth weight < 1250 grams who have required endotracheal tube and mechanical ventilation within the first 7 days of life, and have been on an invasive mechanical ventilator for at least 48 hours, and have not completed 60 days after birth, and have met the traditional extubation criteria of the institution, and have been considered for elective extubation for the first time. Receives: Other: A model for predicting extubation success based on extubation readiness estimator and lung ultrasonography score |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extubation success
Not to be reintubated for at least 5 days during the post-extubation period.
Measured: For at least 5 days during the post-extubation period.
Secondary outcomes (6)
The incidence of morbidities related with prematurity.
The incidence of morbidities related with prematurity (e.g. bronchopulmonary dysplasia, death and/or BPD, air leak syndromes, necrotizing enterocolitis, grade II and higher Intraventricular hemorrhage, retinopathy of prematurity, patent ductus arteriosus).
Bronchopulmonary dysplasia will be assessed by attending clinicians based on the diagnostic criteria 2001 NICHD.
- Air leaks will be assessed by chest X-ray.
- Necrotizing enterocolitis will be assessed by abdominal X-ray and abdominal ultrasonography.
- Intraventricular hemorrhage will be assessed by cranial ultrasonography.
- Retinopathy of prematurity will be assessed by an expert ophthalmologist.
- Patent ductus arteriosus will be assessed by echocardiography which will be performed by a pediatric cardiologist.
Measured: 40 weeks' postmenstrual age.
Length of stay in the hospital.
Length of stay in the hospital.
Measured: 40 weeks' postmenstrual age.
Time elapsed on mechanical ventilation among survivors and the time taken with supplemental oxygen.
Time elapsed on mechanical ventilation among survivors and the time taken with supplemental oxygen.
Measured: 40 weeks' postmenstrual age.
Total noninvasive support time.
Total noninvasive support time until 40 weeks' postmenstrual age.
Measured: 40 weeks' postmenstrual age.
Percentage of time spent below 90% and above 95% on the SpO2 histogram.
Percentage of time spent below 90% and above 95% on the SpO2 histogram during the first 5 days of the post-extubation period.
Measured: During the first 5 days of the post-extubation period.
Time to re-intubation in babies who are reintubated after extubation.
Time to re-intubation in babies who are reintubated after extubation.
Measured: During the first 5 days of the post-extubation period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2021
- Study start20 Apr 2021
- Primary completion20 Apr 2023 (estimated)
- Study completion20 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Neonatal Respiratory FailureStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- 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
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Collaborators
- Başakşehir Çam & Sakura City Hospital
- Responsible party
- Sponsor
- Investigators
- Eren Ozek, Study director, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05081973
- Sponsor's protocol ID
- MarmaraU_Neonatal
- Status last verified
- Oct 2021
- First submitted
- 23 Sep 2021
- Last updated
- 18 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Shi Y, Muniraman H, Biniwale M, Ramanathan R. A Review on Non-invasive Respiratory Support for Management of Respiratory Distress in Extremely Preterm Infants. Front Pediatr. 2020 May 28;8:270. doi: 10.3389/fped.2020.00270. eCollection 2020.
PubMed 32548084El Amrousy D, Elgendy M, Eltomey M, Elmashad AE. Value of lung ultrasonography to predict weaning success in ventilated neonates. Pediatr Pulmonol. 2020 Sep;55(9):2452-2456. doi: 10.1002/ppul.24934. Epub 2020 Jul 8.
PubMed 32609928Brat R, Yousef N, Klifa R, Reynaud S, Shankar Aguilera S, De Luca D. Lung Ultrasonography Score to Evaluate Oxygenation and Surfactant Need in Neonates Treated With Continuous Positive Airway Pressure. JAMA Pediatr. 2015 Aug;169(8):e151797. doi: 10.1001/jamapediatrics.2015.1797. Epub 2015 Aug 3.
PubMed 26237465Gupta D, Greenberg RG, Sharma A, Natarajan G, Cotten M, Thomas R, Chawla S. A predictive model for extubation readiness in extremely preterm infants. J Perinatol. 2019 Dec;39(12):1663-1669. doi: 10.1038/s41372-019-0475-x. Epub 2019 Aug 27.
PubMed 31455825
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Model for Predicting Extubation Success Based on the "Extubation Readiness Estimator" and Lung Ultrasonography Score in Premature Babies
- ClinicalTrials.gov ID
- NCT05081973
- Acronym / sponsor ID
- MarmaraU_Neonatal
- Keywords
- Neonate, Extubation Failure, Lung Ultrasonography Score, Extubation Readiness Estimator
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Collaborators
- Başakşehir Çam & Sakura City Hospital
- Study start
- 20 Apr 2021 (actual)
- Primary completion
- 20 Apr 2023 (estimated)
- Study completion
- 20 Apr 2024 (estimated)
- First posted
- 18 Oct 2021 (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.
Invasive mechanical ventilation is a life-saving treatment in critically ill newborns with respiratory failure. However, continuing this treatment for a long time may have negative consequences, especially bronchopulmonary dysplasia (BPD) secondary to mechanotrauma. For this reason, it is essential to terminate the mechanical ventilation treatment at the most appropriate time.
About half of the extremely preterm babies may fail extubation even if the clinical criteria traditionally used for extubation are met. Unsuccessful extubation is associated with increased intraventricular bleeding, death, BPD, death or BPD, longer duration of ventilator support.
When respiratory failure and lung pathologies of extremely preterm babies begin to improve, the target for mechanical ventilation should be early and successful extubation. Currently, the decision to extubate a preterm baby is primarily based on clinical judgment. Only a few studies that showed the low predictive value and limited utility using different measures have evaluated readiness for extubation. Lung ultrasonography (USG) is a noninvasive bedside technique that has been found useful for predicting the success of weaning from the ventilator in adults; however, very little data are available in neonates. In a recently published study, it was proposed an extubation readiness estimation tool based on clinical and demographic data of preterm babies who were attempted elective extubation.
The researchers' hypothesis is that the use of a model based on extubation success scoring and lung USG scoring before extubation reduces the failure of the first extubation attempt in very low birth weight infants. The aim of the study is to evaluate the value of using an integrated model based on pre-extubation "extubation readiness predictor" and lung USG scoring to predict extubation success in preterm babies undergoing invasive mechanical ventilation.
Detailed description
Long-term invasive mechanical ventilation may have detrimental effects in preterm infants, although it is a life-saving treatment in critically ill newborns with respiratory failure. (e.g. bronchopulmonary dysplasia (BPD), superimposed bacterial infections and colonization, air leak, etc.). For this reason, it is essential to terminate the mechanical ventilation treatment at the most appropriate time.
A significant portion of the extremely preterm babies may fail extubation even if the clinical criteria traditionally used for extubation are met. Unsuccessful extubation is associated with increased intraventricular bleeding, death, BPD, death or BPD, longer duration of ventilator support.
When respiratory failure and lung pathologies of extremely preterm babies begin to improve, the target for mechanical ventilation should be early and successful extubation. Currently, the decision to extubate a preterm baby is primarily based on clinical judgment. Only a few studies that showed the low predictive value and limited utility using different measures have evaluated readiness for extubation. Lung ultrasonography (USG) is a noninvasive bedside technique that has been found useful for predicting the success of weaning from the ventilator in adults; however, very little data are available in neonates. In a recently published study, it was proposed an extubation readiness estimation tool based on clinical and demographic data of preterm babies who were attempted elective extubation.
The researchers' hypothesis is that the use of a model based on extubation success scoring and lung USG scoring before extubation; reduces the failure of the first extubation attempt in very low birth weight infants. The aim of the study is to evaluate the value of using a model based on pre-extubation "extubation readiness predictor" and lung USG scoring to predict extubation success in preterm babies undergoing invasive mechanical ventilation.
This study is a prospective observational study. The study is planned to be conducted in infants with a birth weight <1250 g, who were intubated within the first 7 days of life, remained intubated invasive conventional mechanical ventilation for at least 48 hours, did not complete the postnatal 60 days, and met the traditional extubation criteria of the institution and were considered for elective extubation for the first time.
An "informed consent form" will be obtained from the parents of the babies included in the study. The birth dates, protocol numbers, birth types, maternal histories, genders, weeks of gestation and birth weights of the babies will be recorded.
The usual institutional routine approaches will be applied after the baby is born.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intubated preterm infants | – | Other: A model for predicting extubation success based on extubation readiness estimator and lung ultrasonography scoreInfants with a birth weight < 1250 grams who have required endotracheal tube and mechanical ventilation within the first 7 days of life, and have been on an invasive mechanical ventilator for at least 48 hours, and have not completed 60 days after birth, and have met the traditional extubation criteria of the institution, and have been considered for elective extubation for the first time. |
Who may qualify
- Ages
- 48 hours to 60 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All premature infants with planned extubation during the study period.
Key inclusion criteria (11 listed)
- Birth weight <1250 gr
- Being intubated within the first 7 days of life and then followed on mechanical ventilation
- Being intubated for at least 48 hours
- Not completing the postnatal 60 days
- Meeting conventional clinical extubation criteria
Key exclusion criteria (14 listed)
- Infants with a gestational age of 34 weeks or more
- Infants with unplanned and spontaneous extubation
- Infants who have tried extubation before
- Infants with hydrops fetalis
- Infants with chest deformities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A model for predicting extubation success based on extubation readiness estimator and lung ultrasonography scoreParameters to be recorded before and after extubation to create a "new dual extubation model" from all babies who met the extubation criteria included in the study: 1. "Lung ultrasound score": Lung ultrasound will be performed prior to the extubation and after the extubation. Lung aeration will be scored based on three chest areas for each side (upper anterior, lower anterior and lateral) and a score of 0 to 3 points will be given for each area (Total score ranges from 0 to 18 points). 2. "Probability of Successful Extubation": It will be calculated by extubation readiness estimator provided by the website named http://extubation.net/. This parameter will be calculated only 1 hour prior to the scheduled extubation time. | Other | Intubated preterm infants |
Primary outcome
Extubation success
Time frame: For at least 5 days during the post-extubation period.
Not to be reintubated for at least 5 days during the post-extubation period.
6 secondary outcomes
The incidence of morbidities related with prematurity.
Time frame: 40 weeks' postmenstrual age.
Length of stay in the hospital.
Time frame: 40 weeks' postmenstrual age.
Time elapsed on mechanical ventilation among survivors and the time taken with supplemental oxygen.
Time frame: 40 weeks' postmenstrual age.
Total noninvasive support time.
Time frame: 40 weeks' postmenstrual age.
Percentage of time spent below 90% and above 95% on the SpO2 histogram.
Time frame: During the first 5 days of the post-extubation period.
Time to re-intubation in babies who are reintubated after extubation.
Time frame: During the first 5 days of the post-extubation period.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2021.
- Background: PubMed 32548084Shi Y, Muniraman H, Biniwale M, Ramanathan R. A Review on Non-invasive Respiratory Support for Management of Respiratory Distress in Extremely Preterm Infants. Front Pediatr. 2020 May 28;8:270. doi: 10.3389/fped.2020.00270. eCollection 2020.
- Background: PubMed 32609928El Amrousy D, Elgendy M, Eltomey M, Elmashad AE. Value of lung ultrasonography to predict weaning success in ventilated neonates. Pediatr Pulmonol. 2020 Sep;55(9):2452-2456. doi: 10.1002/ppul.24934. Epub 2020 Jul 8.
- Background: PubMed 26237465Brat R, Yousef N, Klifa R, Reynaud S, Shankar Aguilera S, De Luca D. Lung Ultrasonography Score to Evaluate Oxygenation and Surfactant Need in Neonates Treated With Continuous Positive Airway Pressure. JAMA Pediatr. 2015 Aug;169(8):e151797. doi: 10.1001/jamapediatrics.2015.1797. Epub 2015 Aug 3.
- Background: PubMed 31455825Gupta D, Greenberg RG, Sharma A, Natarajan G, Cotten M, Thomas R, Chawla S. A predictive model for extubation readiness in extremely preterm infants. J Perinatol. 2019 Dec;39(12):1663-1669. doi: 10.1038/s41372-019-0475-x. Epub 2019 Aug 27.
- Individual participant dataSharing planned: Undecided
Related trials for Neonatal Respiratory Failure
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingObservational study
Respiratory Progression in Adults With Duchenne Muscular Dystrophy.
Duchenne Muscular Dystrophy (DMD), Respiratory Function Decline
Active, not recruiting
Delayed Cord Clamping With Oxygen In Extremely Low Gestation Infants
IVH- Intraventricular Hemorrhage, Extreme Prematurity
Not yet recruiting
TORCH-LATAM-003: Regional Advanced-Therapy Pathways for Congenital Heart Disease
Congenital Heart Disease, Advanced Heart Failure
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.
Eren Ozek study director
Marmara University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Respiratory Failure and Invasive Mechanical Ventilation, run by Marmara University at 2 sites in Turkey (Türkiye).
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 11 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 18 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Asli Memisoglu, MD (+905468807300, acinarmemisoglu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extubation success (time frame: For at least 5 days during the post-extubation period.). 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 NCT05081973, which also lists 4 linked publications.
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 18 Oct 2021.