Back to resultsSustained Lung Inflation in Preterm Infants
Primary Purpose
Preterm Infant
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Sustained lung inflation (SLI)
Continuous positive airway pressure (CPAP)
Sponsored by
About this trial
This is an interventional treatment trial for Preterm Infant
Eligibility 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
Sites / Locations
- Kasralainy Cairo University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Sustained lung inflation
Control
Arm 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.
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.
Outcomes
Primary Outcome Measures
Need for invasive mechanical ventilation or death
Treatment failure; defined as the need for intubation and invasive mechanical ventilation or death
Secondary Outcome Measures
Duration of invasive mechanical ventilation
The duration of intubation and invasive mechanical ventilation (in days)
Pneumothorax
Pneumothorax, documented by radiological findings
Bronchopulmonary dysplasia
Bronchopulmonary dysplasia, defined as the need for more than 21% oxygen for at least 28 days
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03518762
Brief Title
Sustained Lung Inflation in Preterm Infants
Official Title
Effect of Application of Sustained Lung Inflation on the Respiratory Outcome of Preterm Infants With Respiratory Distress Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
December 21, 2014 (Actual)
Primary Completion Date
January 18, 2017 (Actual)
Study Completion Date
September 5, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kasr El Aini Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Infant
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sustained lung inflation
Arm Type
Experimental
Arm 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.
Arm Title
Control
Arm Type
Other
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Sustained lung inflation (SLI)
Intervention Description
SLI was given using a peak pressure of 20 cm H₂O sustained for 15 seconds,using a T-piece resuscitator, Neopuff device
Intervention Type
Procedure
Intervention Name(s)
Continuous positive airway pressure (CPAP)
Intervention Description
CPAP through an appropriate mask using a pressure 5 cm H₂O,using a T-piece resuscitator, Neopuff device.
Primary Outcome Measure Information:
Title
Need for invasive mechanical ventilation or death
Description
Treatment failure; defined as the need for intubation and invasive mechanical ventilation or death
Time Frame
From birth up to 72 hours of life
Secondary Outcome Measure Information:
Title
Duration of invasive mechanical ventilation
Description
The duration of intubation and invasive mechanical ventilation (in days)
Time Frame
From date of birth until the date of discharge home or death from any cause, whichever came first, assessed upto 100 days
Title
Pneumothorax
Description
Pneumothorax, documented by radiological findings
Time Frame
From date of birth until the date of discharge home or death from any cause, whichever came first, assessed upto 100 days
Title
Bronchopulmonary dysplasia
Description
Bronchopulmonary dysplasia, defined as the need for more than 21% oxygen for at least 28 days
Time Frame
Assessed at 36 weeks postmenstrual age or discharge, whichever came first
10. Eligibility
Sex
All
Maximum Age & Unit of Time
1 Minute
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Kasralainy Cairo University
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33254237
Citation
Abuel Hamd WA, El Sherbiny DE, El Houchi SZ, Iskandar IF, Akmal DM. Sustained Lung Inflation in Pre-term Infants at Birth: A Randomized Controlled Trial. J Trop Pediatr. 2021 Jan 29;67(1):fmaa097. doi: 10.1093/tropej/fmaa097.
Results Reference
derived
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Sustained Lung Inflation in Preterm Infants
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