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Sustained Lung Inflation in Preterm Infants

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ClinicalTrials.gov Identifier: NCT03518762
Recruitment Status : Completed
First Posted : May 8, 2018
Last Update Posted : May 8, 2018
Sponsor:
Information provided by (Responsible Party):
Douaa El Saied El Sherbiny, 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.

Condition or disease Intervention/treatment Phase
Preterm Infant Procedure: Sustained lung inflation (SLI) Procedure: Continuous positive airway pressure (CPAP) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: Effect of Application of Sustained Lung Inflation on the Respiratory Outcome of Preterm Infants With Respiratory Distress Syndrome
Actual Study Start Date : December 2014
Actual Primary Completion Date : January 2017
Actual Study Completion Date : April 2017


Arm Intervention/treatment
Experimental: Sustained lung inflation

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.
Procedure: Sustained 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

Procedure: Continuous positive airway pressure (CPAP)
CPAP through an appropriate mask using a pressure 5 cm H₂O,using a T-piece resuscitator, Neopuff device.

Control

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.
Procedure: Continuous positive airway pressure (CPAP)
CPAP through an appropriate mask using a pressure 5 cm H₂O,using a T-piece resuscitator, Neopuff device.




Primary Outcome Measures :
  1. Need for invasive mechanical ventilation [ Time Frame: From birth up to 72 hours of life ]
    The need for intubation and invasive mechanical ventilation


Secondary Outcome Measures :
  1. Duration of invasive mechanical ventilation [ Time Frame: 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)

  2. Pneumothorax [ 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, documented by radiological findings

  3. Bronchopulmonary dysplasia [ Time Frame: 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



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Ages Eligible for Study:   up to 1 Minute   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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Responsible Party: Douaa El Saied El Sherbiny, Doctor, Kasr El Aini Hospital
ClinicalTrials.gov Identifier: NCT03518762     History of Changes
Other Study ID Numbers: 75381
First Posted: May 8, 2018    Key Record Dates
Last Update Posted: May 8, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications