Ventilatory Management of the Preterm Neonate in the Delivery Room

NCT01255826 | Completed Phase 2 DMC

• 2 other identifiers: Dina Shinkar MD protocolSustianed inflation trial
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Distress Syndrome, Newborn

Keywords

Preterm; Neonates; Delivery room; Resuscitation; Ventilation; Neopuff; CPAP

Outcome Measures

Primary Outcomes (2)

• 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

• Need for mechanical ventilation for neonates on nCPAP

  28 days

Secondary Outcomes (10)

• Occurrence and duration of oxygen therapy.

  28 days

• Bronchopulmonary dysplasia (BPD): defined as oxygen requirements more than 28 days.

  28 days

• Pulmonary air leaks

  28 days

• Patent ductus arteriosus (PDA).

  7 days

• Necrotizing enterocolitis (NEC).

  28 days

Study Arms (2)

Sustained lung inflation followed by CPAP

ACTIVE COMPARATOR

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.

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

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

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

Interventions

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

Sustained lung inflation followed by CPAP

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

Conventional self inflating bag and mask ventilation

Eligibility Criteria

• Age: 27 Weeks - 33 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Preterm infants (gestational age \< 34 weeks)

You may not qualify if:

• \. Neonates with major congenital anomalies (congenital heart disease, neural tube defect, trisomy, etc.).
• Meconium aspiration syndrome, congenital diaphragmatic hernia and anterior abdominal wall defect.
• Maternal chorioamnionitis. 4.Neonates with gestational age \< 26 weeks and /or birth weight less than 750 grams.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Gynecology and Obstetrics hospital, Ain-Shams University

Cairo, Egypt

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome, Newborn; Premature Birth; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiratory Distress Syndrome; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mohamed Sami El Shimi, MD

  Ain Shams University

  PRINCIPAL INVESTIGATOR

• Hesham Abdel Samie Awad, MD

  Ain Shams University

  PRINCIPAL INVESTIGATOR

• Tarek Mohey El Gammacy, MD

  Ain Shams University

  PRINCIPAL INVESTIGATOR

• Ola Galal Badr El Deen, MD

  Ain Shams University

  PRINCIPAL INVESTIGATOR

• Dina Mohamed Mohamed Shinkar, MSc

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 7, 2010
• First Posted: December 8, 2010
• Study Start: January 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: August 31, 2017

Record last verified: 2017-08

Locations

EG (1)