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

Not Applicable

Completed

• Conditions: Respiratory Distress Syndrome, Infant; Prematurity

• Registration Number: NCT01721629
• Lead Sponsor: Aarhus University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-09-25
• Study First Submitted QC: 2012-11-05
• Study First Posted: 2012-11-06
• Status Verified: 2017-04
• Primary Completion: 2017-04-28
• Study Completion: 2017-04-28
• Last Update Submitted: 2017-04-28
• Last Update Posted: 2017-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 380

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Weight at a gestational age of 40 weeks	Up to 16 weeks

Secondary Outcome Measures

Name	Time	Method
Parental anxiety	Up to 6 months
Duration of nasal CPAP therapy	Up to 6 months
Length of stay in the hospital	Expected median 54 days
Weight at completed withdrawal of nasal CPAP	From date of birth until the date of complete withdrawal of nasal CPAP. Expected median of 14 days
Duration of oxygen treatment	Up to 6 months
Occurence of bronchopulmonary dysplasia	Up to 12 weeks	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)
Depression in parents	Up to 6 months

Trial Locations

Locations (6)

Aalborg University Hospital, Department of Pediatrics; 🇩🇰 Aalborg, DK, Denmark

Aarhus University Hospital, Department of Pediatrics; 🇩🇰 Aarhus, DK, Denmark

Herning Hospital, Department of Pediatrics; 🇩🇰 Herning, DK, Denmark

Viborg Hospital, Department of Pediatrics; 🇩🇰 Viborg, DK, Denmark

Vendsyssel Hospital, Department of Pediatrics; 🇩🇰 Hjørring, Denmark

Randers Hospital, Department of Pediatrics; 🇩🇰 Randers, Denmark