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

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 Overview

• Status: Completed
• Conditions: Respiratory Distress Syndrome, Infant; Prematurity
• Intervention / Treatment: Procedure: Sudden wean of nasal CPAP; Procedure: Gradual wean of nasal CPAP

• Study Type: Interventional
• Enrollment (Actual): 380
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Hjørring, Denmark, 9800
    • Vendsyssel Hospital, Department of Pediatrics
  • Randers, Denmark, 8930
    • Randers Hospital, Department of Pediatrics
  • DK
    • Aalborg, DK, Denmark, 9000
      • Aalborg University Hospital, Department of Pediatrics
    • Aarhus, DK, Denmark, 8200
      • Aarhus University Hospital, Department of Pediatrics
    • Herning, DK, Denmark, 7400
      • Herning Hospital, Department of Pediatrics
    • Viborg, DK, Denmark, 8800
      • Viborg Hospital, Department of Pediatrics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 6 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Procedure: Sudden wean of nasal CPAP
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.	Procedure: Gradual wean of nasal CPAP

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Duration of nasal CPAP therapy		Up to 6 months
Length of stay in the hospital		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)	Up to 12 weeks
Parental anxiety		Up to 6 months
Depression in parents		Up to 6 months

Collaborators and Investigators

• Sponsor: Aarhus University Hospital
• Investigators: Principal Investigator: Christina F Jensen, MD, The Perinatal Epidemiology Research Unit and Department of Paediatrics, Aarhus University Hospital; Study Director: Tine B Henriksen, Professor, Department of Paediatrics, Aarhus University Hospital; Study Chair: Kirsten Wisborg, Centre Director, DMSc, Aarhus University Hospital, Head-Neuro Centre; Study Chair: Finn Ebbesen, Professor, Department of Paediatrics, Aalborg University Hospital; Study Chair: Anna S Sørensen, MD, Ph.D., The Perinatal Epidemiology Research Unit and Department of Paediatrics, Aarhus University Hospital

Publications and helpful links

General Publications

• Jensen CF, Sellmer A, Ebbesen F, Cipliene R, Johansen A, Hansen RM, Nielsen JP, Nikitina OH, Petersen JP, Henriksen TB. Sudden vs Pressure Wean From Nasal Continuous Positive Airway Pressure in Infants Born Before 32 Weeks of Gestation: A Randomized Clinical Trial. JAMA Pediatr. 2018 Sep 1;172(9):824-831. doi: 10.1001/jamapediatrics.2018.2074.

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): April 28, 2017
• Study Completion (Actual): April 28, 2017

Study Registration Dates

• First Submitted: September 25, 2012
• First Submitted That Met QC Criteria: November 5, 2012
• First Posted (Estimate): November 6, 2012

Study Record Updates

• Last Update Posted (Actual): May 1, 2017
• Last Update Submitted That Met QC Criteria: April 28, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Randomized controlled trial; Premature infants; Respiratory distress syndrome; Nasal cpap weaning
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Infant, Premature, Diseases; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Hyaline Membrane Disease
• Other Study ID Numbers: AAUH190280