Ventilatory Management of the Preterm Neonate in the Delivery Room

Ain Shams University

Status and phase: Completed; Phase 2

Conditions: Respiratory Distress Syndrome, Newborn

Treatments: Procedure: Resuscitation of preterm neonates by intermittent bag and mask ventilation using self inflating bag.; Procedure: Resuscitation of preterm neonates by sustained lung inflation through T piece device followed by CPAP

Study type: Interventional

Funder types: Other

Identifiers

NCT01255826

Dina Shinkar MD protocol

Sustianed inflation trial (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 112 patients

Sex: All

Ages: 27 to 33 weeks old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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112 participants in 2 patient groups

Sustained lung inflation followed by CPAP

Active Comparator group

Description:

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.

Treatment:

Procedure: Resuscitation of preterm neonates by sustained lung inflation through T piece device followed by CPAP

Conventional self inflating bag and mask ventilation

Active Comparator group

Description:

Intermittent bag and mask ventilation using a self-inflating bag with an oxygen reservoir.

Treatment:

Procedure: Resuscitation of preterm neonates by intermittent bag and mask ventilation using self inflating bag.