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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
Zekai Tahir Burak Women's Health Research and Education Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Respiratory Distress Syndrome

Eligibility Criteria

undefined - 3 Minutes (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Preterm infant with gestational age of 26 weeks 0 days and 29 weeks 6 days will be included.

Exclusion Criteria:

  1. Presence of major congenital anomaly,
  2. Patients with hydrops fetalis and pulmonary hypoplasia
  3. 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

    First Posted
    August 15, 2016
    Last Updated
    September 10, 2016
    Sponsor
    Zekai Tahir Burak Women's Health Research and Education Hospital
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    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

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    SLI MANEUVER and RESPIRATORY MORBIDITIES

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