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E-23596 - Use of NCPAP Cycling to Wean Preterm Infants

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ClinicalTrials.gov Identifier: NCT02114112
Recruitment Status : Terminated (Due to new respiratory quality control initiative introduced in the NICU, recruitment for the study was stopped.)
First Posted : April 15, 2014
Last Update Posted : April 15, 2014
Sponsor:
Collaborator:
Alberta Children's Hospital
Information provided by (Responsible Party):
ABHAY LODHA, University of Calgary

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.


Condition or disease Intervention/treatment Phase
Premature Birth Other: NCPAP cycling Other: NCPAP continuous Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Randomised Controlled Trial to Study the Effect of Nasal Continuous Positive Airway Pressure (NCPAP) Cycling on Successful Weaning When Compared With Nasal Continuous Positive Airway Pressure (NCPAP) in Premature Infants of 25-28 Weeks Gestation
Study Start Date : January 2011
Actual Primary Completion Date : November 2012
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group A-NCPAP Cycling group
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
Active Comparator: Group B-Continuous NCPAP
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



Primary Outcome Measures :
  1. Successful weaning off NCPAP at the end of 72 hours of the intervention. [ Time Frame: 72 hours ]
    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


Secondary Outcome Measures :
  1. The duration of NCPAP [ Time Frame: 36 weeks post menstrual age ]
  2. Bronchopulmonary dysplasia [ Time Frame: 36 weeks post mentstrual age ]
  3. Retinopathy of prematurity stage 3 or higher [ Time Frame: 36 weeks post menstrual age ]


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Ages Eligible for Study:   up to 75 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Major congenital
  • Chromosomal anomalies.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02114112


Locations
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Canada, Alberta
Foothills Medical Centre, Room C211, 1403 - 29th Street NW
Calgary, Alberta, Canada, T2N 2T9
Sponsors and Collaborators
University of Calgary
Alberta Children's Hospital
Investigators
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Principal Investigator: Abhay Lodha, MD, DM,MSc University of Calgary

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Responsible Party: ABHAY LODHA, Staff Neonatologist, University of Calgary
ClinicalTrials.gov Identifier: NCT02114112     History of Changes
Other Study ID Numbers: E-23596
First Posted: April 15, 2014    Key Record Dates
Last Update Posted: April 15, 2014
Last Verified: April 2014

Keywords provided by ABHAY LODHA, University of Calgary:
Bronchopulmonary dysplasia
Continuous positive airway pressure pressure
Preterms

Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications