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

Aarhus University Hospital380 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

380

Conditions

Prematurity Respiratory Distress Syndrome, Infant

Interventions

Sudden wean of nasal CPAPPROCEDURE

Gradual wean of nasal CPAPPROCEDURE

Eligibility

Sex: ALLMax age: 6 Months

Medical Language ↔ Plain English

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

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

Outcomes

Primary Outcomes

Weight at a gestational age of 40 weeks

Time frame: Up to 16 weeks

Secondary Outcomes

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

Duration of oxygen treatment

Time frame: Up to 6 months

Duration of nasal CPAP therapy

Time frame: Up to 6 months

Length of stay in the hospital

Time frame: Expected median 54 days

Occurence of bronchopulmonary dysplasia

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)

Time frame: Up to 12 weeks

Parental anxiety

Time frame: Up to 6 months

Depression in parents

Time frame: Up to 6 months

Data from ClinicalTrials.gov

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