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A Model for Predicting Extubation Success in Premature Babies

NCT05081973 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 114

Last updated 2021-10-18

No results posted yet for this study

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.

Conditions

  • Neonatal Respiratory Failure
  • Invasive Mechanical Ventilation
  • Extubation Failure

Interventions

OTHER

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.

Sponsors & Collaborators

  • Başakşehir Çam & Sakura City Hospital

    collaborator OTHER_GOV

  • Marmara University

    lead OTHER

Principal Investigators

  • Eren Ozek · Marmara University

Eligibility

Min Age
48 Hours
Max Age
60 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-20
Primary Completion
2023-04-20
Completion
2024-04-20

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05081973 on ClinicalTrials.gov