SLI MANEUVER and RESPIRATORY MORBIDITIES
Primary Purpose
Respiratory Distress Syndrome
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Neopuff; Fisher and Paykel, Auckland, New Zealand
Sponsored by
About this trial
This is an interventional prevention trial for Respiratory Distress Syndrome
Eligibility Criteria
Inclusion Criteria:
- Preterm infant with gestational age of 26 weeks 0 days and 29 weeks 6 days will be included.
Exclusion Criteria:
- Presence of major congenital anomaly,
- Patients with hydrops fetalis and pulmonary hypoplasia
- Consent not provided or refused
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
group 1
group 2
Arm Description
SLI group In this group the preterm infants will receive sustained lung inflation (SLI) via short binasal prongs in the delivery room.
Preterm infants will be assisted in the delivery room without sustained lung inflation.
Outcomes
Primary Outcome Measures
mechanical ventilation requirement
Surfactant requirement, intubation and mechanical ventilation needs within the first 72 hours of life in SLI (Sustained Lung Inflation) maneuver-applied preterm infants and non-SLI-applied preterm infants.
Secondary Outcome Measures
Full Information
NCT ID
NCT02887924
First Posted
August 15, 2016
Last Updated
September 10, 2016
Sponsor
Zekai Tahir Burak Women's Health Research and Education Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02887924
Brief Title
SLI MANEUVER and RESPIRATORY MORBIDITIES
Official Title
THE EFFECT OF SUSTAINED LUNG INFLATION MANEUVER APPLIED THROUGH NASAL PRONG ON EARLY AND LATE RESPIRATORY MORBIDITIES IN PRETERM INFANTS
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
August 2016 (undefined)
Primary Completion Date
July 2017 (Anticipated)
Study Completion Date
September 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zekai Tahir Burak Women's Health Research and Education Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Purpose: The investigators hypothesis is that, as compared to the only nCPAP-applied group, application of SLI maneuver followed by respiratory support with nCPAP immediately afterwards in preterm infants at high risk for RDS would reduce the need for intubation and mechanical ventilation in early period and ultimately will improve respiratory outcomes.
Detailed Description
Primary Outcome Measures:
Surfactant need, intubation and mechanical ventilation needs within the first 72 hours of life in SLI (Sustained Lung Inflation) maneuver-applied preterm infants and non-SLI-applied preterm infants.
Secondary Outcome Measures:
Heart rate, fractional inspiratory oxygen, CPAP pressure and oxygen saturation within the first 72 hours of life in preterm infants
Total non-invasive, invasive respiratory support time
The presence of and the degree of BPD (Bronchopulmonary dysplasia)
Premature morbidities such as PDA (patent ductus arteriosus), IVH (intraventricular hemorrhage), NEC (necrotizing enterocolitis), ROP (retinopathy of prematurity)
Feeding intolerance, reaching birth weight and transition to full oral feeding time
Study Design Randomization Group 1: Group that received SLI maneuver immediately after birth followed by nCPAP.
Group 2: Group that received nCPAP after birth. Following the oral and nasal aspirates, SLI at 25 cm H2O pressure will be applied for 15 seconds by using t-piece refreshing and binasal prongs and 5-cm nCPAP at H2O pressure will be applied.
Patients will be observed for 5-10 seconds in terms of cardiorespiratory functions following SLI maneuver. If respiratory failure continues during nCPAP (such as apnea, gasping) and/or heart rate is > 60 / min but < 100 / min , SLI maneuver will be repeated at the same pressure for the same time period. If heart rate > 60 / min but <100 / min persists after the second SLI maneuver, resuscitation will be applied in line with the guidelines of American Academy of Pediatrics.
The control group of infants will receive nCPAP support at 5 cm H2O pressure and be supported in line with the guidelines of American Academy of Pediatrics.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress Syndrome
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
group 1
Arm Type
Active Comparator
Arm Description
SLI group In this group the preterm infants will receive sustained lung inflation (SLI) via short binasal prongs in the delivery room.
Arm Title
group 2
Arm Type
Placebo Comparator
Arm Description
Preterm infants will be assisted in the delivery room without sustained lung inflation.
Intervention Type
Device
Intervention Name(s)
Neopuff; Fisher and Paykel, Auckland, New Zealand
Other Intervention Name(s)
SUSTAINED LUNG INFLATION MANEUVER
Intervention Description
Following the oral and nasal aspirates, SLI at 25 cm H2O pressure will be applied for 15 seconds by using t-piece refreshing and binasal prongs and 5-cm nCPAP at H2O pressure will be applied.
Primary Outcome Measure Information:
Title
mechanical ventilation requirement
Description
Surfactant requirement, intubation and mechanical ventilation needs within the first 72 hours of life in SLI (Sustained Lung Inflation) maneuver-applied preterm infants and non-SLI-applied preterm infants.
Time Frame
72 hours
10. Eligibility
Sex
All
Maximum Age & Unit of Time
3 Minutes
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Preterm infant with gestational age of 26 weeks 0 days and 29 weeks 6 days will be included.
Exclusion Criteria:
Presence of major congenital anomaly,
Patients with hydrops fetalis and pulmonary hypoplasia
Consent not provided or refused
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
SLI MANEUVER and RESPIRATORY MORBIDITIES
We'll reach out to this number within 24 hrs