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

Aarhus University Hospital

Status: Completed

Conditions: Prematurity; Respiratory Distress Syndrome, Infant

Treatments: Procedure: Sudden wean of nasal CPAP; Procedure: Gradual wean of nasal CPAP

Study type: Interventional

Funder types: Other

Identifiers

NCT01721629

AAUH190280

Details and patient eligibility

About

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.

Enrollment: 380 patients

Sex: All

Ages: Under 6 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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380 participants in 2 patient groups

Sudden wean of nasal CPAP

Other group

Description:

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.

Treatment:

Procedure: Sudden wean of nasal CPAP

Gradual wean of nasal CPAP pressure

Other group

Description:

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.

Treatment:

Procedure: Gradual wean of nasal CPAP