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.
Who can participate
Age range
48 Hours – 60 Days
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
* 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
Exclusion Criteria:
* 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)
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Extubation success
Timeframe: For at least 5 days during the post-extubation period.