Ventilatory Management of the Preterm Neonate in the Delivery Room

NCT ID: NCT01255826

Last Updated: 2017-08-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2013-12-31

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.

Conditions

Respiratory Distress Syndrome, Newborn

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Sustained lung inflation 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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: PROCEDURE

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.

Conventional self inflating bag and mask ventilation

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 27 Weeks
• Maximum Eligible Age: 33 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Dina Mohamed Mohamed Shinkar

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohamed Sami El Shimi, MD

Role: PRINCIPAL_INVESTIGATOR

Ain Shams University

Hesham Abdel Samie Awad, MD

Role: PRINCIPAL_INVESTIGATOR

Ain Shams University

Tarek Mohey El Gammacy, MD

Role: PRINCIPAL_INVESTIGATOR

Ain Shams University

Ola Galal Badr El Deen, MD

Role: PRINCIPAL_INVESTIGATOR

Ain Shams University

Dina Mohamed Mohamed Shinkar, MSc

Role: PRINCIPAL_INVESTIGATOR

Ain Shams University

Locations

Gynecology and Obstetrics hospital, Ain-Shams University

Cairo, , Egypt

Countries

Egypt

Other Identifiers

Sustianed inflation trial

Identifier Type: REGISTRY

Identifier Source: secondary_id

Dina Shinkar MD protocol

Identifier Type: -

Identifier Source: org_study_id