NCT02887924

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Aug 2016

Shorter than P25 for phase_4

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

August 15, 2016

Completed
18 days until next milestone

First Posted

Study publicly available on registry

September 2, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

September 13, 2016

Status Verified

August 1, 2016

Enrollment Period

11 months

First QC Date

August 15, 2016

Last Update Submit

September 10, 2016

Conditions

Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

group 1

ACTIVE COMPARATOR

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

group 2

PLACEBO COMPARATOR

Preterm infants will be assisted in the delivery room without sustained lung inflation.

Device: Neopuff; Fisher and Paykel, Auckland, New Zealand

Interventions

Neopuff; Fisher and Paykel, Auckland, New ZealandDEVICE

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.

Also known as: SUSTAINED LUNG INFLATION MANEUVER
group 1group 2

Eligibility Criteria

AgeUp to 3 Minutes
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • Presence of major congenital anomaly,
  • Patients with hydrops fetalis and pulmonary hypoplasia
  • Consent not provided or refused

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 15, 2016

First Posted

September 2, 2016

Study Start

August 1, 2016

Primary Completion

July 1, 2017

Study Completion

September 1, 2017

Last Updated

September 13, 2016

Record last verified: 2016-08