Ventilatory Management of the Preterm Neonate in the Delivery Room
- Conditions
- Respiratory Distress Syndrome, Newborn
- Interventions
- Procedure: Resuscitation of preterm neonates by sustained lung inflation through T piece device followed by CPAPProcedure: Resuscitation of preterm neonates by intermittent bag and mask ventilation using self inflating bag.
- Registration Number
- NCT01255826
- Lead Sponsor
- Ain Shams University
- Brief Summary
The purpose of this study is to evaluate sustained lung inflation followed by early nCPAP as delivery room ventilatory management for preterm neonates at risk of respiratory distress syndrome in reducing their need for mechanical ventilation and ameliorating lung injury without inducing adverse effects compared with intermittent bag and mask ventilation.
- Detailed Description
Neonatal resuscitation provides lifesaving intervention that, if properly conducted, not only can reduce mortality but probably can significantly decrease subsequent morbidity.
Premature infants need appropriate respiratory support and a lung-protective strategy, starting from the delivery room where, on the contrary, an inadequate respiratory approach may influence pulmonary outcome.
Mechanical ventilation in the form of positive pressure ventilation has remained the mainstay of treatment of respiratory distress syndrome (RDS) in preterm babies. In recent years, a number of new ventilation strategies have been introduced but the problem of bronchopulmonary dysplasia (BPD) has not been solved.
Sustained lung inflation (SLI) lead to a large increase in the tidal volume and the functional residual capacity(FCR) as this intervention may influence the clearance of lung fluids and allow a more even distribution of air throughout the lungs, thus facilitating the formation of FRC.
Nasal CPAP and early PEEP act through stabilization and subsequent recruitment of collapsed alveoli, increased FRC resulting in increased alveolar surface area for gas exchange and a decrease in intrapulmonary shunt .also it conserves endogenous surfactant.
Previous studies with promising results showed that a combination of sustained lung inflation and early nasal CPAP may be the most effective and least injurious way to recruit the lung in preterm neonates at birth.
This study will evaluate sustained lung inflation followed by early nCPAP as delivery room ventilatory management for preterm neonates at risk of respiratory distress syndrome in reducing their need for mechanical ventilation and ameliorating lung injury without inducing adverse effects compared with intermittent bag and mask ventilation.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 112
- Preterm infants (gestational age < 34 weeks)
-
- Neonates with major congenital anomalies (congenital heart disease, neural tube defect, trisomy, etc.).
2.Meconium aspiration syndrome, congenital diaphragmatic hernia and anterior abdominal wall defect.
3.Maternal chorioamnionitis. 4.Neonates with gestational age < 26 weeks and /or birth weight less than 750 grams.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sustained lung inflation followed by CPAP Resuscitation of preterm neonates by sustained lung inflation through T piece device followed by CPAP Sustained pressure-controlled inflation using a neonatal mask and a T-piece ventilator (NeoPuff Infant Resuscitator; Fisher \& Paykel, Auckland, New Zealand). This will be followed by early CPAP. Conventional self inflating bag and mask ventilation Resuscitation of preterm neonates by intermittent bag and mask ventilation using self inflating bag. Intermittent bag and mask ventilation using a self-inflating bag with an oxygen reservoir.
- Primary Outcome Measures
Name Time Method Need for mechanical ventilation for neonates on nCPAP 28 days Proportionate of neonates in each group who will need endotracheal intubation after failure of positive pressure ventilation through face mask in the delivery room. 2 minutes
- Secondary Outcome Measures
Name Time Method Pulmonary air leaks 28 days Patent ductus arteriosus (PDA). 7 days Intraventricular hemorrhage (IVH). 28 days Bronchopulmonary dysplasia (BPD): defined as oxygen requirements more than 28 days. 28 days Necrotizing enterocolitis (NEC). 28 days Delivery room death or death during admission. 28 days Neonatal sepsis. 28 days Occurrence and duration of oxygen therapy. 28 days Length of NICU stay. 28 days Inflammatory mediators before and after resuscitation 2 hours Serum Interleukin-1β (IL-1β) and Tumor Necrosis Factor-α (TNF-α)will be measured both initial cord blood before any resuscitation is done and a second time two hours after resuscitation.
Trial Locations
- Locations (1)
Gynecology and Obstetrics hospital, Ain-Shams University
🇪🇬Cairo, Egypt