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

NCT01721629 | Completed DMC

• 1 other identifier: AAUH190280
• Study Type: interventional
• Target: 380
• Locations: 1 country
• Sites: 6

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.

Conditions

Prematurity; Respiratory Distress Syndrome, Infant

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Weight at a gestational age of 40 weeks

  Up to 16 weeks

Secondary Outcomes (7)

• 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

  Up to 12 weeks

Study Arms (2)

Sudden wean of nasal CPAP

OTHER

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

OTHER

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

Interventions

Sudden wean of nasal CPAP PROCEDURE

Sudden wean of nasal CPAP

Gradual wean of nasal CPAP PROCEDURE

Gradual wean of nasal CPAP pressure

Eligibility Criteria

• Age: Up to 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Aarhus University Hospital: lead

Study Sites (6)

Aalborg University Hospital, Department of Pediatrics

Aalborg, DK, 9000, Denmark

Location

Aarhus University Hospital, Department of Pediatrics

Aarhus, DK, 8200, Denmark

Location

Herning Hospital, Department of Pediatrics

Herning, DK, 7400, Denmark

Location

Viborg Hospital, Department of Pediatrics

Viborg, DK, 8800, Denmark

Location

Vendsyssel Hospital, Department of Pediatrics

Hjørring, 9800, Denmark

Location

Randers Hospital, Department of Pediatrics

Randers, 8930, Denmark

Location

Related Publications (1)

• 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.

  PMID: 30039171 DERIVED

MeSH Terms

Conditions

Premature Birth; Respiratory Distress Syndrome, Newborn; Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Christina F Jensen, MD

  The Perinatal Epidemiology Research Unit and Department of Paediatrics, Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

• Tine B Henriksen, Professor

  Department of Paediatrics, Aarhus University Hospital

  STUDY DIRECTOR

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Ph.D. student

Study Record Dates

• First Submitted: September 25, 2012
• First Posted: November 6, 2012
• Study Start: September 1, 2012
• Primary Completion: April 28, 2017
• Study Completion: April 28, 2017
• Last Updated: May 1, 2017

Record last verified: 2017-04

Locations

DK (6)