Ventilatory Management of the Preterm Neonate in the Delivery Room

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.

Conditions

• Respiratory Distress Syndrome, Newborn

Interventions

PROCEDURE

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

After oropharyngeal and nasal suctioning, if there are no signs of spontaneous breathing or breathing is insufficient and/or heart rate is below 100 bpm, the following approach will be followed:Pressure-controlled (20 cm H2O) inflation will be sustained for 15 secs, using a neonatal mask and a T-piece ventilator (NeoPuff Infant Resuscitator; Fisher \& Paykel).To avoid pressure leakage, we will use a neonatal mask of appropriate size which adequately cover both the mouth and nostrils of infants. This pressure controlled inflation will be followed by CPAP at 5 Cm H2O.This procedure will be repeated a second time with a pressure of 25 cm H2O for 15 secs if breathing remained insufficient and/or the heart rate is \< 100 bpm and/or the infant is cyanotic. To be followed by CPAP at 6 Cm H2O.A third puff with a pressure of 30 cm H2O for 15 secs will be used after few seconds if inadequate heart rate and respiration was not reached. This will be followed by CPAP at 7 Cm H2O.

PROCEDURE

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

After oropharyngeal and nasal suctioning, if there is no signs of spontaneous breathing or breathing is insufficient and/or heart rate is below 100 bpm, intermittent mask and bag ventilation will be administrated at a rate 40-60 per minute using a self-inflating bag and mask with an oxygen reservoir.

Sponsors & Collaborators

• Ain Shams University

  lead OTHER

Principal Investigators

• Mohamed Sami El Shimi, MD · Ain Shams University

• Hesham Abdel Samie Awad, MD · Ain Shams University

• Tarek Mohey El Gammacy, MD · Ain Shams University

• Ola Galal Badr El Deen, MD · Ain Shams University

• Dina Mohamed Mohamed Shinkar, MSc · Ain Shams University

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

27 Weeks

Max Age

33 Weeks

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-01-31

Primary Completion

2013-12-31

Completion

2013-12-31

Countries

• Egypt

Study Locations