Weaning of Nasal Continuous Positive Airway Pressure in Infants Born With a Gestational Age Under 32 Weeks: a Randomized Controlled Multicenter Trial
Status: Completed
Location: See all (6) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Maximum Age: 6 months
Healthy Volunteers: f
View:
• 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)
Locations
Other Locations
Denmark
Aalborg University Hospital, Department of Pediatrics
Aalborg
Aarhus University Hospital, Department of Pediatrics
Aarhus
Herning Hospital, Department of Pediatrics
Herning
Vendsyssel Hospital, Department of Pediatrics
Hjørring
Randers Hospital, Department of Pediatrics
Randers
Viborg Hospital, Department of Pediatrics
Viborg
Time Frame
Start Date: 2012-09
Completion Date: 2017-04-28
Participants
Target number of participants: 380
Treatments
Other: 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.
Other: 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.
Authors
Rasa Cipliene, Finn Ebbesen, Tine B Henriksen
Related Therapeutic Areas
Sponsors
Leads: Aarhus University Hospital