NCT02901652

Brief Summary

Purpose is to compare introduction of NIPPV (Nasal Intermittent Positive-Pressure Ventilation) and nBiPAP (Nasal Bi-level Positive Airway Pressure) 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
325

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2016

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

First Submitted

Initial submission to the registry

August 2, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 15, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
Last Updated

July 18, 2019

Status Verified

October 1, 2018

Enrollment Period

3 years

First QC Date

August 2, 2016

Last Update Submit

July 15, 2019

Conditions

PrematurityRespiratory Distress Syndrome

Outcome Measures

Primary Outcomes (1)

  • surfactant requirement

    surfactant requirement within the first 72 hours of life

    72 HOURS

Study Arms (2)

NIPPV

ACTIVE COMPARATOR

noninvasive respiratory support devices This group receiving Nasal Intermittent Positive Pressure Ventilation (NIPPV) treatment.

Device: noninvasive respiratory support devices

BİPAP

ACTIVE COMPARATOR

noninvasive respiratory support devices This group receive Bi-Level Positive Airway Pressure (BIPAP) treatment.

Device: noninvasive respiratory support devices

Interventions

noninvasive respiratory support devicesDEVICE
BİPAPNIPPV

Eligibility Criteria

Age1 Hour - 3 Days
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:

  • 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

Premature BirthRespiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesLung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Officials

  • Suna Oğuz, MD

    Zekai Tahir Burak Women's Health Research and Education Hospital

    STUDY DIRECTOR

Central Study Contacts

Mehmet Büyüktiryaki, MD

CONTACT

+905054525576mbuyuktiryaki@yahoo.com

Suna Oguz, MD

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

August 2, 2016

First Posted

September 15, 2016

Study Start

September 1, 2016

Primary Completion

September 1, 2019

Study Completion

September 30, 2019

Last Updated

July 18, 2019

Record last verified: 2018-10

Locations

TU(1)