NCT02114112

Brief Summary

Objective: To compare the effectiveness of nasal continuous positive airway pressure (NCPAP) cycling to continuous NCPAP in successful weaning of preterm infants of 25-28 weeks gestation to nasal prongs. Methods: A total of 40 infants with a gestational age (GA) of 25-28 weeks ventilated for respiratory distress syndrome (RDS) and extubated to NCPAP are eligible for the study. They will be randomized to NCPAP cycling {Group A; cycling between NCPAP of 4 cm and 1litre per minute of nasal prongs} or to continuous CPAP at 4 cm of water (Group B). Primary outcome is the number of babies who came off NCPAP at the end of 72 hours of the intervention and remained off NCPAP for the next 72 hours. The duration of NCPAP, Bronchopulmonary dysplasia (BPD) at 36 weeks post menstrual age and Retinopathy of Prematurity (ROP) stage ≥3 will be the secondary outcomes.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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 1, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 6, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 15, 2014

Completed
Last Updated

April 15, 2014

Status Verified

April 1, 2014

Enrollment Period

1.8 years

First QC Date

April 6, 2014

Last Update Submit

April 10, 2014

Conditions

Premature Birth

Keywords

Bronchopulmonary dysplasiaContinuous positive airway pressure pressurePreterms

Outcome Measures

Primary Outcomes (1)

  • Successful weaning off NCPAP at the end of 72 hours of the intervention.

    Primary outcome was successful weaning off NCPAP at the end of 72 hours of the intervention and remained off NCPAP for the next 72 hours

    72 hours

Secondary Outcomes (3)

  • The duration of NCPAP

    36 weeks post menstrual age

  • Bronchopulmonary dysplasia

    36 weeks post mentstrual age

  • Retinopathy of prematurity stage 3 or higher

    36 weeks post menstrual age

Study Arms (2)

Group A-NCPAP Cycling group

EXPERIMENTAL

Infants in Group A were cycled between NCPAP and nasal prongs. For the first 12 hours, infants received 10 hours of NCPAP and 2 hours of 1 litre per minute of nasal prongs (NP). For the next 12 hours, infants received 8 hours of NCPAP and 4 hours of NP. In the subsequent 24 hours, infants alternated between 6 hours of NCPAP and 6 hours of NP. In the last 24 hours of intervention they alternated between 4 hours of NCPAP and 8 hours of NP.

Other: NCPAP cycling

Group B-Continuous NCPAP

ACTIVE COMPARATOR

Infants randomized to group B received continuous NCPAP at a CPAP distending pressure of 4 cm of water for 72 hours. Both the groups after 72 hours of intervention were weaned to 1litre per minute NP. During the intervention period all infants were scored using the ACoRN respiratory score on a 12 hourly basis.

Other: NCPAP continuous

Interventions

NCPAP cyclingOTHER
Group A-NCPAP Cycling group
NCPAP continuousOTHER
Group B-Continuous NCPAP

Eligibility Criteria

Age72 Hours - 75 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Preterm infants between 25-28 weeks gestation
  • Ventilated for respiratory distress syndrome (RDS)
  • Extubated to NCPAP for at least 72 hours.

You may not qualify if:

  • Major congenital
  • Chromosomal anomalies.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foothills Medical Centre, Room C211, 1403 - 29th Street NW

Calgary, Alberta, T2N 2T9, Canada

Location

MeSH Terms

Conditions

Premature BirthBronchopulmonary Dysplasia

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesVentilator-Induced Lung InjuryLung InjuryLung DiseasesRespiratory Tract DiseasesInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Positive-Pressure RespirationRespiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Abhay Lodha, MD, DM,MSc

    University of Calgary

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Neonatologist

Study Record Dates

First Submitted

April 6, 2014

First Posted

April 15, 2014

Study Start

January 1, 2011

Primary Completion

November 1, 2012

Study Completion

March 1, 2014

Last Updated

April 15, 2014

Record last verified: 2014-04

Locations

CA(1)