Clinical trial NCT01721629: Weaning of Nasal Continuous Positive Airway Pressure (CPAP) in Premature Infants
Official title: Weaning of Nasal Continuous Positive Airway Pressure in Infants Born With a Gestational Age Under 32 Weeks: a Randomized Controlled Multicenter Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prematurity
Respiratory Distress Syndrome, Infant
Keywords: Nasal cpap weaning
Premature infants
Respiratory distress syndrome
Randomized controlled trial
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
First posted: 2012-11-06
Enrollment: 380
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Weight at a gestational age of 40 weeks
timeFrame: Up to 16 weeks
Secondary outcomes:
measure: Weight at completed withdrawal of nasal CPAP
timeFrame: From date of birth until the date of complete withdrawal of nasal CPAP. Expected median of 14 days
measure: Duration of oxygen treatment
timeFrame: Up to 6 months
measure: Duration of nasal CPAP therapy
timeFrame: Up to 6 months
measure: Length of stay in the hospital
timeFrame: Expected median 54 days
measure: Occurence of bronchopulmonary dysplasia
timeFrame: Up to 12 weeks
measure: Parental anxiety
timeFrame: Up to 6 months
measure: Depression in parents
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University Hospital, Department of Pediatrics
state: DK
city: Aarhus
country: Denmark
facility: Aarhus University Hospital, Department of Pediatrics
state: DK
city: Herning
country: Denmark
facility: Herning Hospital, Department of Pediatrics
state: DK
city: Viborg
country: Denmark
facility: Viborg Hospital, Department of Pediatrics
state: DK
city: Hjørring
country: Denmark
facility: Vendsyssel Hospital, Department of Pediatrics
city: Randers
country: Denmark
facility: Randers Hospital, Department of Pediatrics
Study officials:
affiliation: The Perinatal Epidemiology Research Unit and Department of Paediatrics, Aarhus University Hospital
name: Christina F Jensen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Paediatrics, Aarhus University Hospital
name: Tine B Henriksen, Professor
role: STUDY_DIRECTOR
affiliation: Aarhus University Hospital, Head-Neuro Centre
name: Kirsten Wisborg, Centre Director, DMSc
role: STUDY_CHAIR
affiliation: Department of Paediatrics, Aalborg University Hospital
name: Finn Ebbesen, Professor
role: STUDY_CHAIR
affiliation: The Perinatal Epidemiology Research Unit and Department of Paediatrics, Aarhus University Hospital
name: Anna S Sørensen, MD, Ph.D.
role: STUDY_CHAIR
References:
citation: 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.