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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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02887924
Enrollment
250
Registered
2016-09-02
Start date
2016-08-31
Completion date
2017-09-30
Last updated
2016-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Distress Syndrome

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.

Interventions

DEVICENeopuff; 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.

Sponsors

Zekai Tahir Burak Women's Health Research and Education Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 3 Minutes
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
mechanical ventilation requirement72 hoursSurfactant 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026