SLI MANEUVER and RESPIRATORY MORBIDITIES

Phase 4

• Conditions: Respiratory Distress Syndrome
• Interventions: Device: Neopuff; Fisher and Paykel, Auckland, New Zealand

• Registration Number: NCT02887924
• Lead Sponsor: 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.

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 Timeline

• Status Verified: 2016-08
• Study Start: 2016-08
• Study First Submitted: 2016-08-15
• Study First Submitted QC: 2016-09-01
• Study First Posted: 2016-09-02
• Last Update Submitted: 2016-09-10
• Last Update Posted: 2016-09-13
• Primary Completion: 2017-07
• Study Completion: 2017-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group 1	Neopuff; Fisher and Paykel, Auckland, New Zealand	SLI group In this group the preterm infants will receive sustained lung inflation (SLI) via short binasal prongs in the delivery room.
group 2	Neopuff; Fisher and Paykel, Auckland, New Zealand	Preterm infants will be assisted in the delivery room without sustained lung inflation.

Primary Outcome Measures

Name	Time	Method
mechanical ventilation requirement	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.