Neonatal Respiratory Failure Clinical Trial
Official title:
A Model for Predicting Extubation Success Based on the "Extubation Readiness Estimator" and Lung Ultrasonography Score in Premature Babies
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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05508308 -
Automated Versus Manual Control Of Oxygen For Preterm Infants On Continuous Positive Airway Pressure In Nigeria
|
N/A | |
Recruiting |
NCT05194761 -
Normal Saline Nebulization on Prevention of Extubation Failure in Neonates
|
N/A | |
Recruiting |
NCT05127070 -
Evaluating the NeoTree in Malawi and Zimbabwe
|
||
Recruiting |
NCT06123143 -
Flow and Grow - The Ideal Time to Wean CPAP Off In Extremely Low Birth Weight Infants
|
N/A | |
Completed |
NCT03166826 -
Development of Modified Combined Apgar Scoring System for Evaluation of Infants in the Delivery Room
|
||
Not yet recruiting |
NCT01379820 -
Use of Orotracheal Continuous Positive Airway Pressure (CPAP) in Newborns With Respiratory Failure
|
Phase 2/Phase 3 | |
Completed |
NCT03154112 -
Validation of a Novel Oxygen Consumption Measurement Technique in Neonates
|
||
Recruiting |
NCT05451953 -
Providing Oxygen During Intubation in the NICU Trial
|
N/A | |
Completed |
NCT01531010 -
Pressure-limited Ventilation Versus Volume-targeted Ventilation in Preterm Newborns
|
N/A | |
Completed |
NCT03591835 -
Endotracheal Tube Placement in Neonatal Intubation
|
N/A | |
Not yet recruiting |
NCT04640467 -
Prediction of Late Fetal Growth Restriction Using Cerebroplacental Ratio
|
||
Recruiting |
NCT01778829 -
Non Invasive Ventilation Versus Continuous Positive Airway Pressure After Extubation of Very Low Birth Weight Infants.
|
Phase 3 | |
Active, not recruiting |
NCT01318824 -
A Study of Bi-Level Positive Airway Pressure (BIPAP) Versus Non Invasive Positive Pressure Ventilation (NIPPV) for Neonatal Respiratory Failure
|
Phase 3 | |
Withdrawn |
NCT01675388 -
Hypothermia During ECMO to Decrease Brain Injury
|
N/A | |
Completed |
NCT01376544 -
Trial of Weaning by Synchronized Ventilation
|
N/A | |
Completed |
NCT05036603 -
Comparison of the Acute Effects of Chest Physiotherapy Methods Applied in Different Positions in Preterm Newborns
|
N/A |