NCT02846597

Brief Summary

The appropriate pressure and duration needed for sustained lung inflation in preterm infants at risk of respiratory distress syndrome have not been well evaluated. We aim for evaluating two different pressures, 20 and 15 cm H2O, for two different duration, 10 and 20 seconds, during the application of sustained lung inflation in the resuscitation of preterm infants with respiratory distress in the delivery room.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2013

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

July 22, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 27, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

April 3, 2018

Status Verified

April 1, 2018

Enrollment Period

3.6 years

First QC Date

July 22, 2016

Last Update Submit

April 1, 2018

Conditions

Respiratory Distress Syndrome

Keywords

Respiratory distress syndromeSustained lung inflationDelivery room

Outcome Measures

Primary Outcomes (1)

  • The need for endotracheal intubation in the delivery room

    One hour

Secondary Outcomes (9)

  • The need for mechanical ventilation

    72 hours

  • Need of surfactant

    72 hours

  • Neonatal mortality

    90 days

  • Broncho Pulmonary Dysplasia ( BPD )

    90 days

  • Intra-Ventricular Hemorrhage ( IVH )

    14 days

  • +4 more secondary outcomes

Study Arms (5)

Control

NO INTERVENTION

Infants in this group will not receive sustained lung inflation in the delivery room and will be put immediately on CPAP at a pressure of 5 cm H2O.

High pressure for long duration

ACTIVE COMPARATOR

Infants in this group will receive sustained lung inflation in the delivery room at a pressure of 20 cm H2O for a duration of 20 second for a single intervention followed by CPAP at a pressure of 5 cm H2O.

Procedure: Sustained lung inflation in preterms (SLI).

High pressure for short duration

ACTIVE COMPARATOR

Infants in this group will receive sustained lung inflation in the delivery room at a pressure of 20 cm H2O for a duration of 10 second for a single intervention followed by CPAP at a pressure of 5 cm H2O.

Procedure: Sustained lung inflation in preterms (SLI).

Low pressure for long duration

ACTIVE COMPARATOR

Infants in this group will receive sustained lung inflation in the delivery room at a pressure of 15 cm H2O for a duration of 20 second for a single intervention followed by CPAP at a pressure of 5 cm H2O.

Procedure: Sustained lung inflation in preterms (SLI).

Low pressure for short duration

ACTIVE COMPARATOR

Infants in this group will receive sustained lung inflation in the delivery room at a pressure of 15 cm H2O for a duration of 10 second for a single intervention followed by CPAP at a pressure of 5 cm H2O.

Procedure: Sustained lung inflation in preterms (SLI).

Interventions

Sustained lung inflation in preterms (SLI).PROCEDURE

Providing a positive pulmonary ventilation with an opening lung pressure for the first breath of preterm infant for a sustained period of time

High pressure for long durationHigh pressure for short durationLow pressure for long durationLow pressure for short duration

Eligibility Criteria

Age1 Day - 1 Day
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Preterm infants with gestational age ≤ 32 weeks' gestation, presented with respiratory distress syndrome at birth

You may not qualify if:

  • \- Preterm infants with no manifestations of respiratory distress syndrome at birth.
  • \- Presence of major congenital malformation (dysmorphic features or anomalies incompatible with life) .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University Children Hospital

Al Mansurah, El Dakahlya, 35111, Egypt

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 22, 2016

First Posted

July 27, 2016

Study Start

March 1, 2013

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

April 3, 2018

Record last verified: 2018-04

Locations

EG(1)