NCT03400670

Brief Summary

is to compare introduction of two different NCPAP methods in terms of mechanical ventilation (MV) need (non-invasive respiratory support failure) and surfactant need within the first 72 hours of life in preterm infants with Respiratory Distress Syndrome (RDS) at 26-30 weeks of gestation.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

January 5, 2017

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 11, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 17, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 5, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2020

Completed
Last Updated

July 16, 2019

Status Verified

January 1, 2017

Enrollment Period

3 years

First QC Date

December 11, 2017

Last Update Submit

July 15, 2019

Conditions

Ventilatory Failure

Keywords

NCPAPRespiratory Distress Syndrome

Outcome Measures

Primary Outcomes (1)

  • noninvasive ventilation failure

    need for mechanical ventilation in the first 72 hours of life

    72 hours

Study Arms (2)

Ventilator NCPAP

ACTIVE COMPARATOR

neonatal ventilator (SLE; Specialised Laboratory Equipment, UK) PEEP: 5 cmH2O

Device: ventilator NCPAP

Infant Flow-driver NCPAP

ACTIVE COMPARATOR

infant flow-driver device (Infant Flow System, Viasys Corp., USA) PEEP:5-8 cmH2O, This group receive variable flow

Device: ventilator NCPAP

Interventions

ventilator NCPAPDEVICE

infants will be randomized into two different NCPAP groups

Also known as: infant flow driver NCPAP
Infant Flow-driver NCPAPVentilator NCPAP

Eligibility Criteria

Age1 Hour - 2 Hours
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 with RDS signs will be included

You may not qualify if:

  • Major congenital anomalies
  • Presence of cardiovascular instability
  • Intubation at admission to the NICU
  • Consent not provided or refused

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zekai Tahir Burak Maternity Teaching

Ankara, 06230, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

HypoventilationRespiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Respiratory InsufficiencyRespiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsLung Diseases

Study Officials

  • Suna Oğuz

    Zekai Tahir Burak Women's Health Research and Education Hospital

    STUDY DIRECTOR

Central Study Contacts

Mehmet Büyüktiryaki, MD

CONTACT

+905054525576mbuyuktiryaki@yahoo.com

Suna Oguz

CONTACT

+90 3123065270serifesuna@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2017

First Posted

January 17, 2018

Study Start

January 5, 2017

Primary Completion

January 5, 2020

Study Completion

February 5, 2020

Last Updated

July 16, 2019

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)