PrematurityNCT01721629
Weaning of Nasal Continuous Positive Airway Pressure (CPAP) in Premature Infants
A study testing Sudden wean of nasal CPAP and Gradual wean of nasal CPAP in people with Prematurity and Respiratory Distress Syndrome, Infant, run by Aarhus University Hospital at 6 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 6 months
- Conditions the study is for
- Prematurity, Respiratory Distress Syndrome, Infant
- What is being tested?
- Sudden wean of nasal CPAP and Gradual wean of nasal CPAP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- 6 sitesDenmark
- Study dates
- Sep 2012to 28 Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Denmark6 sites
Aalborg University Hospital, Department of Pediatrics
Aalborg, DK, 9000
Aarhus University Hospital, Department of Pediatrics
Aarhus, DK, 8200
Herning Hospital, Department of Pediatrics
Herning, DK, 7400
Vendsyssel Hospital, Department of Pediatrics
Hjørring, 9800
Randers Hospital, Department of Pediatrics
Randers, 8930
Viborg Hospital, Department of Pediatrics
Viborg, DK, 8800
About this study
Official title: Weaning of Nasal Continuous Positive Airway Pressure in Infants Born With a Gestational Age Under 32 Weeks: a Randomized Controlled Multicenter Trial
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
- Being tested
- Sudden wean of nasal CPAP, Gradual wean of nasal CPAP
- Keywords
- Nasal cpap weaning, Premature infants, Respiratory distress syndrome, Randomized controlled trial
- Medical subject headings
- Premature Birth, Respiratory Distress Syndrome, Newborn, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sudden wean of nasal CPAPProcedure or surgery
Gradual wean of nasal CPAPProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Gradual wean of nasal CPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight at a gestational age of 40 weeks
Measured: Up to 16 weeks
Secondary outcomes (7)
Weight at completed withdrawal of nasal CPAP
Measured: From date of birth until the date of complete withdrawal of nasal CPAP. Expected median of 14 days
Duration of oxygen treatment
Measured: Up to 6 months
Duration of nasal CPAP therapy
Measured: Up to 6 months
Length of stay in the hospital
Measured: Expected median 54 days
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)
Measured: Up to 12 weeks
Parental anxiety
Measured: Up to 6 months
Depression in parents
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2012 (estimated)
- Study startSep 2012
- Primary completion28 Apr 2017
- Study completion28 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PrematurityStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 380 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christina Friis Jensen, Aarhus University Hospital
- Investigators
- Christina F Jensen, MD, Principal investigator, The Perinatal Epidemiology Research Unit and Department of Paediatrics, Aarhus University HospitalTine B Henriksen, Professor, Study director, Department of Paediatrics, Aarhus University HospitalKirsten Wisborg, Centre Director, DMSc, Study chair, Aarhus University Hospital, Head-Neuro CentreFinn Ebbesen, Professor, Study chair, Department of Paediatrics, Aalborg University HospitalAnna S Sørensen, MD, Ph.D., Study chair, The Perinatal Epidemiology Research Unit and Department of Paediatrics, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01721629
- Sponsor's protocol ID
- AAUH190280
- Status last verified
- Apr 2017
- First submitted
- 25 Sep 2012
- Last updated
- 1 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 30039171
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weaning of Nasal Continuous Positive Airway Pressure in Infants Born With a Gestational Age Under 32 Weeks: a Randomized Controlled Multicenter Trial
- ClinicalTrials.gov ID
- NCT01721629
- Acronym / sponsor ID
- AAUH190280
- Conditions
- Prematurity, Respiratory Distress Syndrome, Infant
- Keywords
- Nasal cpap weaning, Premature infants, Respiratory distress syndrome, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 380 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- 28 Apr 2017 (actual)
- Study completion
- 28 Apr 2017 (actual)
- First posted
- 6 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sudden wean of nasal CPAP | Other | Procedure: Sudden wean of nasal CPAPThe 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. |
| Gradual wean of nasal CPAP pressure | Other | Procedure: Gradual wean of nasal CPAPThe 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. |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sudden wean of nasal CPAP | Procedure or surgery | Sudden wean of nasal CPAP |
| Gradual wean of nasal CPAP | Procedure or surgery | Gradual wean of nasal CPAP pressure |
Primary outcome
Weight at a gestational age of 40 weeks
Time frame: Up to 16 weeks
7 secondary outcomes
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
Duration of oxygen treatment
Time frame: Up to 6 months
Duration of nasal CPAP therapy
Time frame: Up to 6 months
Length of stay in the hospital
Time frame: Expected median 54 days
Occurence of bronchopulmonary dysplasia
Time frame: Up to 12 weeks
Parental anxiety
Time frame: Up to 6 months
Depression in parents
Time frame: Up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2017.
- Derived from this study: PubMed 30039171Jensen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christina F Jensen, MD principal investigator
The Perinatal Epidemiology Research Unit and Department of Paediatrics, Aarhus University Hospital
Tine B Henriksen, Professor study director
Department of Paediatrics, Aarhus University Hospital
Kirsten Wisborg, Centre Director, DMSc study chair
Aarhus University Hospital, Head-Neuro Centre
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sudden wean of nasal CPAP and Gradual wean of nasal CPAP in people with Prematurity and Respiratory Distress Syndrome, Infant, run by Aarhus University Hospital at 6 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight at a gestational age of 40 weeks (time frame: Up to 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01721629, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2017.