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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01721629

Enrollment

380

Registered

2012-11-06

Start date

2012-09-30

Completion date

2017-04-28

Last updated

2017-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prematurity, Respiratory Distress Syndrome, Infant

Keywords

Nasal cpap weaning, Premature infants, Respiratory distress syndrome, Randomized controlled trial

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.

Interventions

PROCEDURESudden wean of nasal CPAP

PROCEDUREGradual wean of nasal CPAP

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 6 Months

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

Design outcomes

Primary

Measure	Time frame
Weight at a gestational age of 40 weeks	Up to 16 weeks

Secondary

Measure	Time frame	Description
Duration of oxygen treatment	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	—
Parental anxiety	Up to 6 months	—
Depression in parents	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)

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026