Sustained Lung Inflation in Preterm Infants

Effect of Application of Sustained Lung Inflation on the Respiratory Outcome of Preterm Infants With Respiratory Distress Syndrome

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.

Study Overview

• Status: Completed
• Conditions: Preterm Infant
• Intervention / Treatment: Procedure: Sustained lung inflation (SLI); Procedure: Continuous positive airway pressure (CPAP)

Detailed Description

Enrolled infants (n=160) were randomized before birth into 2 groups (intervention and control group) in a ratio 1:1. Randomization was done through an online randomizer (www.graphpad.com), and sealed envelopes were used to assign the infant to one of the two groups.

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Kasralainy Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 minute (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sustained lung inflation; Participants in this arm (n=80) received: 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.; 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); SLI was given using a peak pressure of 20 cm H₂O sustained for 15 seconds,using a T-piece resuscitator, Neopuff device; Procedure: Continuous positive airway pressure (CPAP); CPAP through an appropriate mask using a pressure 5 cm H₂O,using a T-piece resuscitator, Neopuff device.
Other: Control; Participants in this arm (n=80) received: Resuscitation according to the American academy of pediatrics guidelines.; 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); CPAP through an appropriate mask using a pressure 5 cm H₂O,using a T-piece resuscitator, Neopuff device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of invasive mechanical ventilation	The duration of intubation and invasive mechanical ventilation (in days)	From date of birth until the date of discharge home or death from any cause, whichever came first, assessed upto 100 days
Pneumothorax	Pneumothorax, documented by radiological findings	From date of birth until the date of discharge home or death from any cause, whichever came first, assessed upto 100 days
Bronchopulmonary dysplasia	Bronchopulmonary dysplasia, defined as the need for more than 21% oxygen for at least 28 days	Assessed at 36 weeks postmenstrual age or discharge, whichever came first

Collaborators and Investigators

• Sponsor: Kasr El Aini Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2014
• Primary Completion (Actual): January 18, 2017
• Study Completion (Actual): September 5, 2017

Study Registration Dates

• First Submitted: April 12, 2018
• First Submitted That Met QC Criteria: May 7, 2018
• First Posted (Actual): May 8, 2018

Study Record Updates

• Last Update Posted (Actual): June 9, 2020
• Last Update Submitted That Met QC Criteria: June 7, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: 75381

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No