NCT02287116

Brief Summary

The investigators aimed to compare the effectiveness of nasal mask and prongs used in CPAP (nasal continuous positive airway pressure)as the initial respiratory support when using minimal ly invasive surfactant therapy (MIST) in preterm infants.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2014

Shorter than P25 for not_applicable

Status
completed

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

May 1, 2014

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 2, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 10, 2014

Completed
Last Updated

November 10, 2014

Status Verified

November 1, 2014

Enrollment Period

Same day

First QC Date

November 2, 2014

Last Update Submit

November 5, 2014

Conditions

Bronchopulmonary DysplasiaDeath

Keywords

preterm infantsCPAPBPDinvasive mechanical ventilationwe aimed determine that affect the rate of BPD and death of NCPAP therapy with nasal prongs or nasal mask as the initial treatment for RDS.

Outcome Measures

Primary Outcomes (1)

  • BPD

    To determine that affect the rate of BPD of NCPAP therapy with nasal prongs or nasal mask as the initial treatment for RDS.

    7 months

Secondary Outcomes (1)

  • death

    7

Study Arms (1)

nasal mask and nasal prongs

NO INTERVENTION
Device: Easy Flow system and INCA® nasal cannulae set

Interventions

Easy Flow system and INCA® nasal cannulae setDEVICE
nasal mask and nasal prongs

Eligibility Criteria

AgeUp to 1 Year
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • One hundred sixty infants born at 26-32 weeks' gestation not endotracheally intubated in the delivery room (DR)

You may not qualify if:

  • Infants with major congenital anomalies, and who required intubation in the DR and no parental consent were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Bronchopulmonary DysplasiaDeath

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung InjuryLung InjuryLung DiseasesRespiratory Tract DiseasesInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
CONTINUOUS POSITIVE AIRWAY PRESSURE VIA BINASAL PRONG VS NASAL MASK: A RANDOMISED CONTROLLED TRIAL

Study Record Dates

First Submitted

November 2, 2014

First Posted

November 10, 2014

Study Start

May 1, 2014

Primary Completion

May 1, 2014

Study Completion

October 1, 2014

Last Updated

November 10, 2014

Record last verified: 2014-11