Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06620107
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-25
Brief Title:
NHFOV Vs NIPPV Post-extubation in Preterm Neonates
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Noninvasive High Frequency Oscillation Ventilation NHFOV in Comparison to Noninvasive Intermittent Positive Pressure Ventilation NIPPV As Post-extubation Support in Preterm Neonates
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
comparison between Noninvasive Intermittent Positive Pressure Ventilation NIPPV and Noninvasive High Frequency Oscillation Ventilation NHFOV post-extubation in preterm neonates as regards the efficacy and their possible complications
Detailed Description:
The global definition of preterm infant by the World Health Organization is any infant born before 37 weeks of gestation Annually an estimated 15 million 111 preterm infants are born worldwide Preterm birth is further classified as extremely preterm amplt28 weeks very preterm 28 to amplt32 weeks and moderate 32 to amplt34 weeks to late preterm 34 to amplt37 weeks
Prematurity has been associated with several risk factors such as history of previous preterm birth pregnancy induced hypertension premature rupture of fetal membranes multiple pregnancy bleeding during pregnancy history of abortion fetal malformation inadequate antenatal care polyhydramnios and previous caesarean section
Preterm neonates are at greater risk of a range of short-term and long-term morbidities Respiratory distress syndrome RDS is one of the most common causes of morbidity and mortality in preterm infants RDS is characterized by a lack of lung surfactant Insufficient surfactant production or secretion results in higher alveolar surface tension leading to atelectasis and impaired gas exchange Respiratory distress typically manifests in newborns as tachypnea intercostal retractions nasal flaring grunting and cyanosis
Invasive mechanical ventilation IMV increases survival in preterm infants with severe RDS However prolonged intubation and mechanical ventilation of preterm infants increases the risk of life-threatening complications including ventilator induced lung injury and airway inflammation leading to bronchopulmonary dysplasia and nosocomial pneumonia and also increases the risk of a poor neurodevelopmental outcome Therefore when caring for premature infants clinicians should focus on weaning from IMV as expeditiously as possible to noninvasive respiratory support NRS
There are many strategies and criteria for weaning including evaluation of ventilatory parameters clinicalbiochemical criteria and predictive indices of extubation that can be followed by or combined with spontaneous breathing trials or gradual withdrawal from ventilatory support
Noninvasive respiratory support modalities include continuous positive airway pressure CPAP high flow nasal cannula HFNC noninvasive intermittent positive pressure ventilation NIPPV bilevel CPAP BiPAP and noninvasive high frequency oscillation ventilation NHFOV
NIPPV is a time cycled pressure limited mode of ventilation Conventional ventilator is used to generate two levels of pressures namely Peak inspiratory pressure and positive end expiratory pressure Additionally a backup rate is provided typically using longer inspiratory time The main drawback of neonatal NIPPV is the lack of synchronization which is difficult to achieve and is often unavailable
NHFOV is the application of a bias flow generating a continuous distending positive pressure with superimposed oscillations which have a constant frequency and an active expiratory phase NHFOV combines the advantages of NCPAP and high-frequency ventilation making it more effective at maintaining alveolar stability eliminating CO2 and limiting barotrauma
The study assumed that NHFOV is more efficacious than NIPPV as regard prevention of the need for re-intubation in preterm infants with gestational age between 32 and 36 weeks and 6 days after their 1st extubation
Prematurity has been associated with several risk factors such as history of previous preterm birth pregnancy induced hypertension premature rupture of fetal membranes multiple pregnancy bleeding during pregnancy history of abortion fetal malformation inadequate antenatal care polyhydramnios and previous caesarean section
Preterm neonates are at greater risk of a range of short-term and long-term morbidities Respiratory distress syndrome RDS is one of the most common causes of morbidity and mortality in preterm infants RDS is characterized by a lack of lung surfactant Insufficient surfactant production or secretion results in higher alveolar surface tension leading to atelectasis and impaired gas exchange Respiratory distress typically manifests in newborns as tachypnea intercostal retractions nasal flaring grunting and cyanosis
Invasive mechanical ventilation IMV increases survival in preterm infants with severe RDS However prolonged intubation and mechanical ventilation of preterm infants increases the risk of life-threatening complications including ventilator induced lung injury and airway inflammation leading to bronchopulmonary dysplasia and nosocomial pneumonia and also increases the risk of a poor neurodevelopmental outcome Therefore when caring for premature infants clinicians should focus on weaning from IMV as expeditiously as possible to noninvasive respiratory support NRS
There are many strategies and criteria for weaning including evaluation of ventilatory parameters clinicalbiochemical criteria and predictive indices of extubation that can be followed by or combined with spontaneous breathing trials or gradual withdrawal from ventilatory support
Noninvasive respiratory support modalities include continuous positive airway pressure CPAP high flow nasal cannula HFNC noninvasive intermittent positive pressure ventilation NIPPV bilevel CPAP BiPAP and noninvasive high frequency oscillation ventilation NHFOV
NIPPV is a time cycled pressure limited mode of ventilation Conventional ventilator is used to generate two levels of pressures namely Peak inspiratory pressure and positive end expiratory pressure Additionally a backup rate is provided typically using longer inspiratory time The main drawback of neonatal NIPPV is the lack of synchronization which is difficult to achieve and is often unavailable
NHFOV is the application of a bias flow generating a continuous distending positive pressure with superimposed oscillations which have a constant frequency and an active expiratory phase NHFOV combines the advantages of NCPAP and high-frequency ventilation making it more effective at maintaining alveolar stability eliminating CO2 and limiting barotrauma
The study assumed that NHFOV is more efficacious than NIPPV as regard prevention of the need for re-intubation in preterm infants with gestational age between 32 and 36 weeks and 6 days after their 1st extubation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None