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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
160
SLI was given using a peak pressure of 20 cm H₂O sustained for 15 seconds,using a T-piece resuscitator, Neopuff device
CPAP through an appropriate mask using a pressure 5 cm H₂O,using a T-piece resuscitator, Neopuff device.
Kasralainy Cairo University
Cairo, Egypt
Need for invasive mechanical ventilation or death
Treatment failure; defined as the need for intubation and invasive mechanical ventilation or death
Time frame: From birth up to 72 hours of life
Duration of invasive mechanical ventilation
The duration of intubation and invasive mechanical ventilation (in days)
Time frame: 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
Time frame: 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
Time frame: Assessed at 36 weeks postmenstrual age or discharge, whichever came first
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