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SLI MANEUVER and RESPIRATORY MORBIDITIES

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ClinicalTrials.gov Identifier: NCT02887924
Recruitment Status : Unknown
Verified August 2016 by Zekai Tahir Burak Women's Health Research and Education Hospital.
Recruitment status was:  Not yet recruiting
First Posted : September 2, 2016
Last Update Posted : September 13, 2016
Sponsor:
Information provided by (Responsible Party):
Zekai Tahir Burak Women's Health Research and Education Hospital

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.

Condition or disease Intervention/treatment Phase
Respiratory Distress Syndrome Device: Neopuff; Fisher and Paykel, Auckland, New Zealand Phase 4

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: THE EFFECT OF SUSTAINED LUNG INFLATION MANEUVER APPLIED THROUGH NASAL PRONG ON EARLY AND LATE RESPIRATORY MORBIDITIES IN PRETERM INFANTS
Study Start Date : August 2016
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : September 2017


Arm Intervention/treatment
Active Comparator: group 1
SLI group In this group the preterm infants will receive sustained lung inflation (SLI) via short binasal prongs in the delivery room.
Device: Neopuff; Fisher and Paykel, Auckland, New Zealand
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.
Other Name: SUSTAINED LUNG INFLATION MANEUVER

Placebo Comparator: group 2
Preterm infants will be assisted in the delivery room without sustained lung inflation.
Device: Neopuff; Fisher and Paykel, Auckland, New Zealand
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.
Other Name: SUSTAINED LUNG INFLATION MANEUVER




Primary Outcome Measures :
  1. mechanical ventilation requirement [ Time Frame: 72 hours ]
    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.



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Ages Eligible for Study:   up to 3 Minutes   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Responsible Party: Zekai Tahir Burak Women's Health Research and Education Hospital
ClinicalTrials.gov Identifier: NCT02887924     History of Changes
Other Study ID Numbers: 12082016
First Posted: September 2, 2016    Key Record Dates
Last Update Posted: September 13, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases