NCT03518762

Brief Summary

This is a randomized controlled study to investigate the effect of application of sustained lung inflation (SLI) at birth on the respiratory outcome of preterm infants with respiratory distress syndrome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2014

Typical duration for not_applicable

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

December 21, 2014

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 18, 2017

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 12, 2018

Completed
26 days until next milestone

First Posted

Study publicly available on registry

May 8, 2018

Completed
Last Updated

June 9, 2020

Status Verified

June 1, 2020

Enrollment Period

2.1 years

First QC Date

April 12, 2018

Last Update Submit

June 7, 2020

Conditions

Preterm Infant

Outcome Measures

Primary Outcomes (1)

  • Need for invasive mechanical ventilation or death

    Treatment failure; defined as the need for intubation and invasive mechanical ventilation or death

    From birth up to 72 hours of life

Secondary Outcomes (3)

  • Duration of invasive mechanical ventilation

    From date of birth until the date of discharge home or death from any cause, whichever came first, assessed upto 100 days

  • Pneumothorax

    From date of birth until the date of discharge home or death from any cause, whichever came first, assessed upto 100 days

  • Bronchopulmonary dysplasia

    Assessed at 36 weeks postmenstrual age or discharge, whichever came first

Study Arms (2)

Sustained lung inflation

EXPERIMENTAL

Participants in this arm (n=80) received: 1. Sustained lung inflation (SLI) manoeuvre(s) was applied once or twice, based on the protocol algorithm. Within the first 60 seconds of life, assessment for the need of advanced resuscitation (defined as the need for more than oxygen and tactile stimulation during resuscitation) was done; * Infants who needed advanced resuscitation were considered to receive SLI as a rescue approach. * Infants who needed only oxygen and tactile stimulation were considered to receive SLI as a prophylactic approach. 2. Then Continuous positive airway pressure (CPAP). Intermittent positive pressure ventilation (IPPV) was given through an ETT, if intubation was needed.

Procedure: Sustained lung inflation (SLI)Procedure: Continuous positive airway pressure (CPAP)

Control

OTHER

Participants in this arm (n=80) received: 1. Resuscitation according to the American academy of pediatrics guidelines. 2. Then Continuous positive airway pressure (CPAP). Intermittent positive pressure ventilation (IPPV) was given through an ETT, if intubation was needed.

Procedure: Continuous positive airway pressure (CPAP)

Interventions

Sustained lung inflation (SLI)PROCEDURE

SLI was given using a peak pressure of 20 cm H₂O sustained for 15 seconds,using a T-piece resuscitator, Neopuff device

Sustained lung inflation
Continuous positive airway pressure (CPAP)PROCEDURE

CPAP through an appropriate mask using a pressure 5 cm H₂O,using a T-piece resuscitator, Neopuff device.

ControlSustained lung inflation

Eligibility Criteria

AgeUp to 1 Minute
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Gestational age ≥ 27 weeks and ≤ 32 weeks
  • Appropriate for gestational age
  • Weight \>800 grams

You may not qualify if:

  • Major congenital anomalies (congenital heart, cerebral, lung or abdominal malformations)
  • Fetal hydrops

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasralainy Cairo University

Cairo, Egypt

Location

Related Publications (1)

  • Abuel Hamd WA, El Sherbiny DE, El Houchi SZ, Iskandar IF, Akmal DM. Sustained Lung Inflation in Pre-term Infants at Birth: A Randomized Controlled Trial. J Trop Pediatr. 2021 Jan 29;67(1):fmaa097. doi: 10.1093/tropej/fmaa097.

    PMID: 33254237DERIVED

MeSH Terms

Conditions

Premature Birth

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure RespirationRespiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

April 12, 2018

First Posted

May 8, 2018

Study Start

December 21, 2014

Primary Completion

January 18, 2017

Study Completion

September 5, 2017

Last Updated

June 9, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)