Sustained Lung Inflation in Preterm Infants

Preterm Infant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03518762
• Other study ID #: 75381
• Status: Completed
• Phase: N/A
• Start date: December 21, 2014
• Est. completion date: September 5, 2017

Study information

• Verified date: June 2020
• Source: Kasr El Aini Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: September 5, 2017
• Est. primary completion date: January 18, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 1 Minute

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Preterm Infant

Intervention

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
• Continuous positive airway pressure (CPAP)
CPAP through an appropriate mask using a pressure 5 cm H2O,using a T-piece resuscitator, Neopuff device.

Locations

Country	Name	City	State
Egypt	Kasralainy Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Kasr El Aini Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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