Weaning of Nasal Continuous Positive Airway Pressure (CPAP) in Premature Infants - Full Text View

Purpose

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.

Condition	Intervention
Prematurity Respiratory Distress Syndrome, Infant	Procedure: Sudden wean of nasal CPAP Procedure: Gradual wean of nasal CPAP

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Weaning of Nasal Continuous Positive Airway Pressure in Infants Born With a Gestational Age Under 32 Weeks: a Randomized Controlled Multicenter Trial

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Premature Babies

U.S. FDA Resources

Further study details as provided by Aarhus University Hospital:

Primary Outcome Measures:

Weight at a gestational age of 40 weeks [ Time Frame: Up to 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
Duration of oxygen treatment [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
Duration of nasal CPAP therapy [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
Length of stay in the hospital [ Time Frame: Expected median 54 days ] [ Designated as safety issue: No ]
Occurence of bronchopulmonary dysplasia [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
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)
Parental anxiety [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
Depression in parents [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	300
Study Start Date:	September 2012
Estimated Study Completion Date:	March 2015
Estimated Primary Completion Date:	September 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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
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

Arms

Assigned Interventions

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

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

Eligibility

Ages Eligible for Study:	up to 6 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01721629

Contacts

Contact: Christina F Jensen, MD	+4551785009	christina.friis.jensen@ki.au.dk
Contact: Tine B Henriksen, Professor	+4578450000	tine.brink.henriksen@ki.au.dk

Locations

Denmark
Aalborg University Hospital, Department of Pediatrics	Recruiting
Aalborg, DK, Denmark, 9000
Contact: Christina F Jensen, MD +4551785009 christina.friis.jensen@ki.au.dk
Contact: Finn F Ebbesen, Professor +4599321300 fe@rn.dk
Principal Investigator: Christina F Jensen, MD
Sub-Investigator: Rasa Cipliene, Consultant
Sub-Investigator: Finn Ebbesen, Professor
Aarhus University Hospital, Department of Pediatrics	Not yet recruiting
Aarhus, DK, Denmark, 8200
Contact: Christina F Jensen, MD +4551785009 christina.friis.jensen@ki.au.dk
Contact: Tine B Henriksen, Professor +4578450000 tine.brink.henriksen@ki.au.dk
Principal Investigator: Christina F Jensen, MD
Sub-Investigator: Tine B Henriksen, Professor
Herning Hospital, Department of Pediatrics	Recruiting
Herning, DK, Denmark, 7400
Contact: Bent Windelborg Nielsen, Consultant +4578433607 Bent.Windelborg.Nielsen@vest.rm.dk
Contact: Christina F Jensen, MD +4551785009 christina.friis.jensen@ki.au.dk
Principal Investigator: Christina F Jensen, MD
Viborg Hospital, Department of Pediatrics	Recruiting
Viborg, DK, Denmark, 8800
Contact: Jens Peter Nielsen, Consultant +4578445541 jens.peter.nielsen@midt.rm.dk
Contact: Christina F Jensen, MD +4551785009 christina.friis.jensen@ki.au.dk
Principal Investigator: Christina F Jensen, MD
Randers Hospital, Department of Pediatrics	Recruiting
Randers, Denmark, 8930
Contact: Christina F Jensen, MD +45 51785009 christina.friis.jensen@ki.au.dk
Contact: Kirsten Wisborg, HOD, DMSc +45 78 42 00 00 Kirsten.Wisborg@randers.rm.dk
Principal Investigator: Christina F Jensen, MD
Sub-Investigator: Kirsten Wisborg, HOD, DMSc

Sponsors and Collaborators

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, HOD, DMSc	Department of Paediatrics, Randers Hospital
Study Chair:	Finn Ebbesen, Professor	Department of Paediatrics, Aalborg University Hospital
Study Chair:	Anna S Sørensen, MD	The Perinatal Epidemiology Research Unit and Department of Paediatrics, Aarhus University Hospital

More Information

No publications provided

Responsible Party:	Christina Friis Jensen, MD, Ph.D. student, Aarhus University Hospital
ClinicalTrials.gov Identifier:	NCT01721629 History of Changes
Other Study ID Numbers:	AAUH190280
Study First Received:	September 25, 2012
Last Updated:	December 7, 2012
Health Authority:	Denmark: Ethics Committee

Keywords provided by Aarhus University Hospital:

Nasal cpap weaning
Premature infants
Respiratory distress syndrome
Randomized controlled trial

Additional relevant MeSH terms:

Respiratory Distress Syndrome, Newborn
Hyaline Membrane Disease
Respiratory Distress Syndrome, Adult
Lung Diseases

Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on May 22, 2013