Sustained Lung Inflation in Preterm Infants
- Conditions
- Preterm Infant
- Interventions
- Procedure: Sustained lung inflation (SLI)Procedure: Continuous positive airway pressure (CPAP)
- Registration Number
- NCT03518762
- Lead Sponsor
- Kasr El Aini Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 160
- Gestational age ≥ 27 weeks and ≤ 32 weeks
- Appropriate for gestational age
- Weight >800 grams
- Major congenital anomalies (congenital heart, cerebral, lung or abdominal malformations)
- Fetal hydrops
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sustained lung inflation Sustained lung inflation (SLI) 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. Sustained lung inflation Continuous positive airway pressure (CPAP) 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. Control Continuous positive airway pressure (CPAP) 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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
Trial Locations
- Locations (1)
Kasralainy Cairo University
🇪🇬Cairo, Egypt