Preterm Infant
Conditions
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.
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.
Interventions
PROCEDURESustained 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
PROCEDUREContinuous positive airway pressure (CPAP)
CPAP through an appropriate mask using a pressure 5 cm H₂O,using a T-piece resuscitator, Neopuff device.
Sponsors
Kasr El Aini Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
No minimum to 1 Minutes
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Need for invasive mechanical ventilation or death | From birth up to 72 hours of life | Treatment failure; defined as the need for intubation and invasive mechanical ventilation or death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | The duration of intubation and invasive mechanical ventilation (in days) |
| Pneumothorax | From date of birth until the date of discharge home or death from any cause, whichever came first, assessed upto 100 days | Pneumothorax, documented by radiological findings |
| Bronchopulmonary dysplasia | Assessed at 36 weeks postmenstrual age or discharge, whichever came first | Bronchopulmonary dysplasia, defined as the need for more than 21% oxygen for at least 28 days |
Countries
Egypt
Outcome results
None listed