Clinical trial NCT05081973: A Model for Predicting Extubation Success in Premature Babies
Official title: A Model for Predicting Extubation Success Based on the "Extubation Readiness Estimator" and Lung Ultrasonography Score in Premature Babies
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neonatal Respiratory Failure
Invasive Mechanical Ventilation
Extubation Failure
Keywords: Neonate
Extubation Failure
Lung Ultrasonography Score
Extubation Readiness Estimator
Lead sponsor: Marmara University
Sponsor class: OTHER
Collaborators: name: Başakşehir Çam & Sakura City Hospital
First posted: 2021-10-18
Enrollment: 114
Sex: ALL
Minimum age (years): 48
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All premature infants with planned extubation during the study period.

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Extubation success
timeFrame: For at least 5 days during the post-extubation period.
Secondary outcomes:
measure: The incidence of morbidities related with prematurity.
timeFrame: 40 weeks' postmenstrual age.
measure: Length of stay in the hospital.
timeFrame: 40 weeks' postmenstrual age.
measure: Time elapsed on mechanical ventilation among survivors and the time taken with supplemental oxygen.
timeFrame: 40 weeks' postmenstrual age.
measure: Total noninvasive support time.
timeFrame: 40 weeks' postmenstrual age.
measure: Percentage of time spent below 90% and above 95% on the SpO2 histogram.
timeFrame: During the first 5 days of the post-extubation period.
measure: Time to re-intubation in babies who are reintubated after extubation.
timeFrame: During the first 5 days of the post-extubation period.
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University Pendik Training and Research Hospital
city: Istanbul
country: Turkey
facility: Basaksehir Cam and Sakura City Hospital
Study officials:
affiliation: Marmara University
name: Eren Ozek
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.