NCT01989442

Brief Summary

The study aims to investigate efficacy and safety of nasal mask and prongs used in non-invasive ventilation in newborns by using esophageal pressure transducer. The parameters including ventilation duration, hospitalization duration, pulmonary outcomes and side effects will be evaluated.

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
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2013

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

November 15, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 21, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

January 15, 2015

Status Verified

January 1, 2015

Enrollment Period

7 months

First QC Date

November 15, 2013

Last Update Submit

January 14, 2015

Conditions

Bronchopulmonary Dysplasia

Keywords

cpap failurebronchopulmonary dysplasianasal traumaventilation durationnon-invasive ventilation

Outcome Measures

Primary Outcomes (1)

  • failure of NIV

    patients who require endotracheal intubation after NIV treatment

    1 year

Secondary Outcomes (1)

  • ventilation duration

    3 days

Other Outcomes (2)

  • bronchopulmonary dysplasia

    1 year

  • septal trauma rate

    1 year

Study Arms (2)

Nasal Mask

EXPERIMENTAL

patients who receive NIV by nasal mask interface after randomization

Device: nasal mask

nasal prong

ACTIVE COMPARATOR

patients who receive NIV by nasal prongs as interface after randomization

Device: binasal prongs

Interventions

binasal prongsDEVICE

patients randomized to binasal prongs for NIV will use binasal prongs as an interface during continuous positive airway pressure support

Also known as: viasys healthcare infant flow system- binasal prongs
nasal prong
nasal maskDEVICE

patients randomized to nasal mask for NIV will use nasal mask as an interface during continuous positive airway pressure support

Also known as: viasys healthcare infant flow system-nasal mask
Nasal Mask

Eligibility Criteria

AgeUp to 28 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • all newborns who require NIV as first line treatment as respiratory support in delivery room or neonatal intensive care unit

You may not qualify if:

  • who are intubated in delivery room or neonatal intensive care unit before randomization
  • with congenital anomaly
  • patients who require NIV more than 3 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara University

Ankara, Ankara, 06300, Turkey (Türkiye)

RECRUITING

Related Publications (2)

  • McCarthy LK, Twomey AR, Molloy EJ, Murphy JF, O'Donnell CP. A randomized trial of nasal prong or face mask for respiratory support for preterm newborns. Pediatrics. 2013 Aug;132(2):e389-95. doi: 10.1542/peds.2013-0446. Epub 2013 Jul 29.

    PMID: 23897911BACKGROUND

  • Kieran EA, Twomey AR, Molloy EJ, Murphy JF, O'Donnell CP. Randomized trial of prongs or mask for nasal continuous positive airway pressure in preterm infants. Pediatrics. 2012 Nov;130(5):e1170-6. doi: 10.1542/peds.2011-3548. Epub 2012 Oct 22.

    PMID: 23090339BACKGROUND

MeSH Terms

Conditions

Bronchopulmonary Dysplasia

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung InjuryLung InjuryLung DiseasesRespiratory Tract DiseasesInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Saadet ARSAN, Professor

    Ankara University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ankara University

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

November 15, 2013

First Posted

November 21, 2013

Study Start

November 1, 2013

Primary Completion

June 1, 2014

Study Completion

January 1, 2015

Last Updated

January 15, 2015

Record last verified: 2015-01

Locations

TU(1)