Trials Sponsors Conditions Drugs Pricing

Conditions

Prematurity Respiratory Distress Syndrome, Infant

Keywords

Nasal cpap weaningPremature infantsRespiratory distress syndromeRandomized 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
+2 more secondary outcomes

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 CPAPProcedure

Sudden wean of nasal CPAP

Gradual wean of nasal CPAPProcedure

Gradual wean of nasal CPAP pressure

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

AgeUp to 6 Months

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

Gestational age \< 32 weeks at birth
Current gestational age \> 28+6 weeks

Sponsors & Collaborators

Aarhus University Hospital
Otherlead

Study Sites (6)

Aalborg University Hospital, Department of Pediatrics

Aalborg, DK, 9000, Denmark

Aarhus University Hospital, Department of Pediatrics

Aarhus, DK, 8200, Denmark

Herning Hospital, Department of Pediatrics

Herning, DK, 7400, Denmark

Viborg Hospital, Department of Pediatrics

Viborg, DK, 8800, Denmark

Vendsyssel Hospital, Department of Pediatrics

Hjørring, 9800, Denmark

Randers Hospital, Department of Pediatrics

Randers, 8930, Denmark

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: 30039171DERIVED

MeSH Terms

Conditions

Premature BirthRespiratory Distress Syndrome, NewbornRespiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesLung DiseasesRespiratory Tract DiseasesRespiration DisordersInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, 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

Enrollment

380 participants (actual enrollment reported by the registry).

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 2012

Date type not reported

This date has not been verified as actual or estimated.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Study Arms (2)

Sudden wean of nasal CPAP

Gradual wean of nasal CPAP pressure

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (6)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Study Arms (2)

Sudden wean of nasal CPAP

Gradual wean of nasal CPAP pressure

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (6)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations