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

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Sudden wean of nasal CPAP

Gradual wean of nasal CPAP

About this trial

This is an interventional treatment trial for Prematurity focused on measuring Nasal cpap weaning, Premature infants, Respiratory distress syndrome, Randomized controlled trial

Eligibility Criteria

undefined - 6 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Aalborg University Hospital, Department of Pediatrics
Aarhus University Hospital, Department of Pediatrics
Herning Hospital, Department of Pediatrics
Viborg Hospital, Department of Pediatrics
Vendsyssel Hospital, Department of Pediatrics
Randers Hospital, Department of Pediatrics

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Sudden wean of nasal CPAP

Gradual wean of nasal CPAP pressure

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Weight at a gestational age of 40 weeks

Secondary Outcome Measures

Weight at completed withdrawal of nasal CPAP

Duration of oxygen treatment

Duration of nasal CPAP therapy

Length of stay in the hospital

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)

Parental anxiety

Depression in parents

Full Information

NCT ID

NCT01721629

First Posted

September 25, 2012

Last Updated

April 28, 2017

Sponsor

Aarhus University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01721629

Brief Title

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

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Completed

Study Start Date

September 2012 (undefined)

Primary Completion Date

April 28, 2017 (Actual)

Study Completion Date

April 28, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Aarhus University Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prematurity, Respiratory Distress Syndrome, Infant

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

380 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sudden wean of nasal CPAP

Arm Type

Other

Arm Description

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.

Arm Title

Gradual wean of nasal CPAP pressure

Arm Type

Other

Arm Description

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.

Intervention Type

Procedure

Intervention Name(s)

Sudden wean of nasal CPAP

Intervention Type

Procedure

Intervention Name(s)

Gradual wean of nasal CPAP

Primary Outcome Measure Information:

Title

Weight at a gestational age of 40 weeks

Time Frame

Up to 16 weeks

Secondary Outcome Measure Information:

Title

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

Title

Duration of oxygen treatment

Time Frame

Up to 6 months

Title

Duration of nasal CPAP therapy

Time Frame

Up to 6 months

Title

Length of stay in the hospital

Time Frame

Expected median 54 days

Title

Occurence of bronchopulmonary dysplasia

Description

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)

Time Frame

Up to 12 weeks

Title

Parental anxiety

Time Frame

Up to 6 months

Title

Depression in parents

Time Frame

Up to 6 months

10. Eligibility

Sex

All

Maximum Age & Unit of Time

6 Months

Accepts Healthy Volunteers

No

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

Overall Study Officials: