A Model for Predicting Extubation Success in Premature Babies
NCT ID: NCT05081973
Last Updated: 2021-10-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
114 participants
OBSERVATIONAL
2021-04-20
2024-04-20
Brief Summary
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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
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
A model for predicting extubation success based on extubation readiness estimator and lung ultrasonography score
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:
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.
Interventions
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A model for predicting extubation success based on extubation readiness estimator and lung ultrasonography score
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:
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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
48 Hours
60 Days
ALL
No
Sponsors
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Başakşehir Çam & Sakura City Hospital
OTHER_GOV
Marmara University
OTHER
Responsible Party
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Principal Investigators
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Eren Ozek
Role: STUDY_DIRECTOR
Marmara University
Locations
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Marmara University Pendik Training and Research Hospital
Istanbul, , Turkey (Türkiye)
Basaksehir Cam and Sakura City Hospital
Istanbul, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
Other Identifiers
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MarmaraU_Neonatal
Identifier Type: -
Identifier Source: org_study_id