Sustained Lung Inflation in Preterm Infants

K

Kasr El Aini Hospital

Status

Completed

Conditions

Preterm Infant

Treatments

Procedure: Sustained lung inflation (SLI)
Procedure: Continuous positive airway pressure (CPAP)

Study type

Interventional

Funder types

Other

Identifiers

NCT03518762
75381

Details and patient eligibility

About

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.

Full 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.

Enrollment

160 patients

Sex

All

Ages

Under 1 minute old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

160 participants in 2 patient groups

Sustained lung inflation
Experimental group
Description:
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.
Treatment:
Procedure: Continuous positive airway pressure (CPAP)
Procedure: Sustained lung inflation (SLI)
Control
Other group
Description:
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.
Treatment:
Procedure: Continuous positive airway pressure (CPAP)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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