SLI MANEUVER and RESPIRATORY MORBIDITIES

THE EFFECT OF SUSTAINED LUNG INFLATION MANEUVER APPLIED THROUGH NASAL PRONG ON EARLY AND LATE RESPIRATORY MORBIDITIES IN PRETERM INFANTS

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.

Study Overview

• Status: Unknown
• Conditions: Respiratory Distress Syndrome
• Intervention / Treatment: Device: Neopuff; Fisher and Paykel, Auckland, New Zealand

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
• Enrollment (Anticipated): 250
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 3 minutes (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: SUSTAINED LUNG INFLATION MANEUVER

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	72 hours

Collaborators and Investigators

• Sponsor: Zekai Tahir Burak Women's Health Research and Education Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (Anticipated): July 1, 2017
• Study Completion (Anticipated): September 1, 2017

Study Registration Dates

• First Submitted: August 15, 2016
• First Submitted That Met QC Criteria: September 1, 2016
• First Posted (Estimate): September 2, 2016

Study Record Updates

• Last Update Posted (Estimate): September 13, 2016
• Last Update Submitted That Met QC Criteria: September 10, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Infant, Premature, Diseases; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn
• Other Study ID Numbers: 12082016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED