Weaning of Nasal Continuous Positive Airway Pressure (CPAP) in Premature Infants

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Aarhus University Hospital
Sponsor:
Information provided by (Responsible Party):
Christina Friis Jensen, Aarhus University Hospital
ClinicalTrials.gov Identifier:
NCT01721629
First received: September 25, 2012
Last updated: January 17, 2014
Last verified: January 2014
  Purpose

The aim of this study is to investigate two different strategies for the withdrawal of CPAP in preterm infants born before 32 weeks of gestation.


Condition Intervention
Prematurity
Respiratory Distress Syndrome, Infant
Procedure: Sudden wean of nasal CPAP
Procedure: Gradual wean of nasal CPAP

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Weaning of Nasal Continuous Positive Airway Pressure in Infants Born With a Gestational Age Under 32 Weeks: a Randomized Controlled Multicenter Trial

Resource links provided by NLM:


Further study details as provided by Aarhus University Hospital:

Primary Outcome Measures:
  • Weight at a gestational age of 40 weeks [ Time Frame: Up to 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Weight at completed withdrawal of nasal CPAP [ Time Frame: From date of birth until the date of complete withdrawal of nasal CPAP. Expected median of 14 days ] [ Designated as safety issue: No ]
  • Duration of oxygen treatment [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
  • Duration of nasal CPAP therapy [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
  • Length of stay in the hospital [ Time Frame: Expected median 54 days ] [ Designated as safety issue: No ]
  • Occurence of bronchopulmonary dysplasia [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
    The occurrence of bronchopulmonary dysplasia is defined as need for oxygen therapy (> 21%) at a gestational age of 36 weeks or treatment with oxygen > 21% for at least 28 days (a day of treatment with oxygen > 21% means that the infant received oxygen > 21% for more than 12 hours that days)

  • Parental anxiety [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
  • Depression in parents [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: September 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sudden wean of nasal CPAP
The CPAP is taken off at the morning ward round. If the discontinuation of the CPAP fails according to prespecified failure criteria, CPAP is recommenced and continued for at least 24 hours. Then a new evaluation takes place and if the infant again meets the inclusion criteria another attempt of sudden wean can be undertaken. Infants are considered successfully weaned if they are off CPAP for three days.
Procedure: Sudden wean of nasal CPAP
Gradual wean of nasal CPAP pressure
The reduction of the CPAP pressure begins at the morning ward round and the pressure is reduced in steps with 1 cmH2O maximum once a day. Each time the pressure is to be reduced the infant needs to be evaluated according to the inclusion criteria and only if these are still met, will the pressure be reduced. When a CPAP pressure at 4 cmH2O is reached the infant is treated with this pressure for 24 hours and then the CPAP is discontinued. Infants are considered successfully weaned if they are off CPAP for three days.
Procedure: Gradual wean of nasal CPAP

  Eligibility

Ages Eligible for Study:   up to 6 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Gestational age < 32 weeks at birth
  • Current gestational age > 28+6 weeks
  • Nasal CPAP for > 24 hours
  • Nasal CPAP pressure < 8 cmH2O
  • Oxygen requirement < 30% and not increasing
  • Respiratory rate < 70 per minute
  • Less than 3 episodes of oxygen saturation < 70% or a heart rate < 70 beat per minute in the preceding 24 hours
  • Tolerates time off CPAP during cares (up to 15 minutes)

Exclusion Criteria:

  • Congenital malformations of the heart (except patent ductus arteriosus, atrial septal defect and patent foramen ovale), lung, and gastrointestinal tract
  • Surgical procedures performed on the gastrointestinal tract
  • Known or suspected to have congenital neuromuscular disease
  • Known or suspected syndrome
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01721629

Contacts
Contact: Christina F Jensen, MD +4551785009 christina.friis.jensen@ki.au.dk
Contact: Tine B Henriksen, Professor +4578450000 tine.brink.henriksen@ki.au.dk

Locations
Denmark
Aalborg University Hospital, Department of Pediatrics Recruiting
Aalborg, DK, Denmark, 9000
Contact: Christina F Jensen, MD    +4551785009    christina.friis.jensen@ki.au.dk   
Contact: Finn F Ebbesen, Professor    +4599321300    fe@rn.dk   
Principal Investigator: Christina F Jensen, MD         
Sub-Investigator: Rasa Cipliene, Consultant         
Sub-Investigator: Finn Ebbesen, Professor         
Aarhus University Hospital, Department of Pediatrics Recruiting
Aarhus, DK, Denmark, 8200
Contact: Christina F Jensen, MD    +4551785009    christina.friis.jensen@ki.au.dk   
Contact: Tine B Henriksen, Professor    +4578450000    tine.brink.henriksen@ki.au.dk   
Principal Investigator: Christina F Jensen, MD         
Sub-Investigator: Tine B Henriksen, Professor         
Herning Hospital, Department of Pediatrics Recruiting
Herning, DK, Denmark, 7400
Contact: Bent Windelborg Nielsen, Consultant    +4578433607    Bent.Windelborg.Nielsen@vest.rm.dk   
Contact: Christina F Jensen, MD    +4551785009    christina.friis.jensen@ki.au.dk   
Principal Investigator: Christina F Jensen, MD         
Viborg Hospital, Department of Pediatrics Recruiting
Viborg, DK, Denmark, 8800
Contact: Jens Peter Nielsen, Consultant    +4578445541    jens.peter.nielsen@midt.rm.dk   
Contact: Christina F Jensen, MD    +4551785009    christina.friis.jensen@ki.au.dk   
Principal Investigator: Christina F Jensen, MD         
Vendsyssel Hospital, Department of Pediatrics Recruiting
Hjørring, Denmark, 9800
Contact: Søren Støvring, Consultant         
Contact: Finn Ebbesen, DMSc         
Principal Investigator: Christina Friis Jensen, MD         
Randers Hospital, Department of Pediatrics Recruiting
Randers, Denmark, 8930
Contact: Christina F Jensen, MD    +45 51785009    christina.friis.jensen@ki.au.dk   
Contact: Kirsten Wisborg, HOD, DMSc    +45 78 42 00 00    Kirsten.Wisborg@randers.rm.dk   
Principal Investigator: Christina F Jensen, MD         
Sponsors and Collaborators
Aarhus University Hospital
Investigators
Principal Investigator: Christina F Jensen, MD The Perinatal Epidemiology Research Unit and Department of Paediatrics, Aarhus University Hospital
Study Director: Tine B Henriksen, Professor Department of Paediatrics, Aarhus University Hospital
Study Chair: Kirsten Wisborg, Centre Director, DMSc Aarhus University Hospital, Head-Neuro Centre
Study Chair: Finn Ebbesen, Professor Department of Paediatrics, Aalborg University Hospital
Study Chair: Anna S Sørensen, MD, Ph.D. The Perinatal Epidemiology Research Unit and Department of Paediatrics, Aarhus University Hospital
  More Information

No publications provided

Responsible Party: Christina Friis Jensen, MD, Ph.D. student, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT01721629     History of Changes
Other Study ID Numbers: AAUH190280
Study First Received: September 25, 2012
Last Updated: January 17, 2014
Health Authority: Denmark: Ethics Committee

Keywords provided by Aarhus University Hospital:
Nasal cpap weaning
Premature infants
Respiratory distress syndrome
Randomized controlled trial

Additional relevant MeSH terms:
Syndrome
Respiratory Distress Syndrome, Newborn
Hyaline Membrane Disease
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on October 02, 2014