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

September 25, 2012
January 17, 2014
September 2012
September 2014   (final data collection date for primary outcome measure)
Weight at a gestational age of 40 weeks [ Time Frame: Up to 16 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01721629 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Weaning of Nasal Continuous Positive Airway Pressure (CPAP) in Premature Infants
Weaning of Nasal Continuous Positive Airway Pressure in Infants Born With a Gestational Age Under 32 Weeks: a Randomized Controlled Multicenter Trial

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Prematurity
  • Respiratory Distress Syndrome, Infant
  • Procedure: Sudden wean of nasal CPAP
  • Procedure: Gradual wean of nasal CPAP
  • 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.
    Intervention: 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.
    Intervention: Procedure: Gradual wean of nasal CPAP
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
March 2015
September 2014   (final data collection date for primary outcome measure)

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
Both
up to 6 Months
No
Contact: Christina F Jensen, MD +4551785009 christina.friis.jensen@ki.au.dk
Contact: Tine B Henriksen, Professor +4578450000 tine.brink.henriksen@ki.au.dk
Denmark
 
NCT01721629
AAUH190280
Yes
Christina Friis Jensen, Aarhus University Hospital
Aarhus University Hospital
Not Provided
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
Aarhus University Hospital
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP