Sustained Lung Inflation in Preterm Infants

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Preterm Infant

Intervention / Treatment
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* Procedure: Sustained lung inflation (SLI)
* Procedure: Continuous positive airway pressure (CPAP)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 1 Minute

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sustained lung inflation<br>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)<br>* SLI was given using a peak pressure of 20 cm H₂O sustained for 15 seconds,using a T-piece resuscitator, Neopuff device<br>Procedure: Continuous positive airway pressure (CPAP)<br>* CPAP through an appropriate mask using a pressure 5 cm H₂O,using a T-piece resuscitator, Neopuff device.<br>|
| Other: Control<br>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)<br>* CPAP through an appropriate mask using a pressure 5 cm H₂O,using a T-piece resuscitator, Neopuff device.<br>|

What is the study measuring?
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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 |