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| Name | Class |
|---|---|
| Başakşehir Çam & Sakura City Hospital | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A model for predicting extubation success based on extubation readiness estimator and lung ultrasonography score | Other | 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:
This parameter will be calculated only 1 hour prior to the scheduled extubation time. |
| Measure | Description | Time Frame |
|---|---|---|
| Extubation success | Not to be reintubated for at least 5 days during the post-extubation period. | For at least 5 days during the post-extubation period. |
| Measure | Description | Time Frame |
|---|---|---|
| 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.
|
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Inclusion Criteria:
Exclusion Criteria:
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All premature infants with planned extubation during the study period.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Asli Memisoglu, MD | Contact | +905468807300 | acinarmemisoglu@gmail.com | |
| Eren Ozek, Prof. | Contact | +905324237568 | ozekeren@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Eren Ozek | Marmara University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Marmara University Pendik Training and Research Hospital | Recruiting | Istanbul | 34899 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32548084 | Background | 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. | |
| 32609928 | Background | El 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. |
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|
| 40 weeks' postmenstrual age. |
| Length of stay in the hospital. | Length of stay in the hospital. | 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. | 40 weeks' postmenstrual age. |
| Total noninvasive support time. | Total noninvasive support time until 40 weeks' postmenstrual age. | 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. | 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. | During the first 5 days of the post-extubation period. |
| Basaksehir Cam and Sakura City Hospital | Active, not recruiting | Istanbul | Turkey (Türkiye) |
| 26237465 | Background | Brat 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. |
| 31455825 | Background | Gupta 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. |