Clinical trial NCT01255826: Ventilatory Management of the Preterm Neonate in the Delivery Room
Official title: Ventilatory Management of the Preterm Neonate in the Delivery Room.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Respiratory Distress Syndrome, Newborn
Keywords: Preterm
Neonates
Delivery room
Resuscitation
Ventilation
Neopuff
CPAP
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2010-12-08
Enrollment: 112
Sex: ALL
Minimum age (years): 27
Maximum age (years): 33
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

* Preterm infants (gestational age \< 34 weeks)

Exclusion Criteria:

* 1. 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.

Primary outcomes:
measure: Proportionate of neonates in each group who will need endotracheal intubation after failure of positive pressure ventilation through face mask in the delivery room.
timeFrame: 2 minutes
measure: Need for mechanical ventilation for neonates on nCPAP
timeFrame: 28 days
Secondary outcomes:
measure: Occurrence and duration of oxygen therapy.
timeFrame: 28 days
measure: Bronchopulmonary dysplasia (BPD): defined as oxygen requirements more than 28 days.
timeFrame: 28 days
measure: Pulmonary air leaks
timeFrame: 28 days
measure: Patent ductus arteriosus (PDA).
timeFrame: 7 days
measure: Necrotizing enterocolitis (NEC).
timeFrame: 28 days
measure: Intraventricular hemorrhage (IVH).
timeFrame: 28 days
measure: Neonatal sepsis.
timeFrame: 28 days
measure: Length of NICU stay.
timeFrame: 28 days
measure: Delivery room death or death during admission.
timeFrame: 28 days
measure: Inflammatory mediators before and after resuscitation
timeFrame: 2 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Gynecology and Obstetrics hospital, Ain-Shams University
Study officials:
affiliation: Ain Shams University
name: Mohamed Sami El Shimi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ain Shams University
name: Hesham Abdel Samie Awad, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ain Shams University
name: Tarek Mohey El Gammacy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ain Shams University
name: Ola Galal Badr El Deen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ain Shams University
name: Dina Mohamed Mohamed Shinkar, MSc
role: PRINCIPAL_INVESTIGATOR
References: