Continuous Positive Airway PressureNCT00482040
Randomized Trial Investigating Four Nasal CPAP Systems in the Management of Apnea of Prematurity
A study testing Stephanie (TM), Infant Flow (TM), Infant Flow advance (TM), Bubble CPAP in people with Continuous Positive Airway Pressure and Apnea of Prematurity, run by University Hospital Tuebingen.
Trial summary
The purpose of this study is to evaluate four different nasal continuous pressure systems, which are usually applied on our neonatal intensive care unit, with regard of their effect on bradycardia and desaturations in preterm infants. Read more about this study
- Who is it for?
- Ages Up to 14 weeks
- Conditions the study is for
- Continuous Positive Airway Pressure, Apnea of Prematurity, CPAP
- What is being tested?
- Stephanie (TM), Infant Flow (TM), Infant Flow advance (TM), Bubble CPAP
- Type of treatment
- Medical device
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Mar 2004to Jan 2006
- 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 14 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- gestational age at birth < 34 weeks
- postconceptional age and body weight at study ≤38 week and >1000 g
- requirement for N-CPAP to treat AOP as judged by the attending neonatologist
Who cannot join
- congenital or chromosomal abnormalities
- acute infections
- intraventricular hemorrhage
- additional inspired oxygen to maintain pulse oximeter saturation SpO2 >92%
- patent ductus arteriosus
About this study
The purpose of this study is to evaluate four different nasal continuous pressure systems, which are usually applied on our neonatal intensive care unit, with regard of their effect on bradycardia and desaturations in preterm infants.
Read the detailed description
BACKGROUND:
Apnea of prematurity (AOP) is a common problem in preterm infants. Nasal respiratory support using either Continuous Positive Airway Pressure (CPAP) or Intermittent Mandatory Ventilation (IMV) are, among others, widely used treatments. Which of the different systems is the most efficient, however, is unclear.
OBJECTIVE:
Efficiency of different CPAP systems on reducing the cumulative percentage of bradycardia and desaturation in preterm infants.
METHODS:
In a prospective, randomized, cross-over trial 32 preterm infants Infants will randomly allocated to receive nasal CPAP delivered by one of the following sys-tems: (1) a conventional IMV-System (Stephanie, Stephan GmbH, Germany with PIP 15 cmH2O, RR 10/min) delivering CPAP via short binasal prongs (Hudson RCI, USA); (2) the Infant-Flow-System (EME Ltd, Great Britain) with CPAP delivery via short binasal prongs; (3) the Infant-Flow-AdvanceTM-System used in the pressure assist mode with PIP 10 cmH2O, RR 10/min; and (4) a nasal underwater bubble CPAP with application via binasal prongs (Hudson RCI, USA).
All systems will be adjusted to achieve an approximate PEEP of 6 cm H2O. Each study lasts 24 hours, during which chest wall and abdominal movements, SaO2, tcPCO2, ECG, esopha-gus pressure and CPAP-/IMV-pressure will be recorded continuously. Infants will be studied in room air in a 15° head tilt prone position while being treated with caffeine (3mg/kg/d).
PRIMARY OUTCOME MEASURE Cumulative percentage of bradycardia (heart rate <80/min) and desaturation (SaO2 <80%) per hour.
- Being tested
- Stephanie (TM), Infant Flow (TM), Infant Flow advance (TM), Bubble CPAP
- Keywords
- CPAP, Preterm, Prematurity, Apnea of prematurity
- Medical subject headings
- Apnea, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stephanie (TM), Infant Flow (TM), Infant Flow advance (TM), Bubble CPAPDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative percentage of bradycardia (heart rate <80 beats/min) and desaturation (SaO2 <80%) per hour
Measured: one year
Secondary outcomes (1)
- Event rates for central apneas, desaturations and bradycardias calculated as the number of respective events per hour of artefact free recording time - relative cumulative event time - baseline heart rate, respiratory rate and oxygen saturation
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2007 (estimated)
- Study startMar 2004
- Study completionJan 2006
Why it stopped: Recruiting took longer than expected due to a lack of eligible patients (very strong inclusion and exclusion criterias)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Continuous Positive Airway PressureStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe 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
- Crossover
- Masking
- Single blind
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Investigators
- Tobias Pantalitschka, MD, Principal investigator, University children´s hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00482040
- Sponsor's protocol ID
- CPAP-I-Study
- Status last verified
- May 2007
- First submitted
- 1 Jun 2007
- Last updated
- 24 Aug 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial Investigating Four Nasal CPAP Systems in the Management of Apnea of Prematurity
- ClinicalTrials.gov ID
- NCT00482040
- Acronym / sponsor ID
- CPAP-I-Study
- Keywords
- CPAP, Preterm, Prematurity, Apnea of prematurity
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruiting took longer than expected due to a lack of eligible patients (very strong inclusion and exclusion criterias)
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- Mar 2004
- Study completion
- Jan 2006 (actual)
- First posted
- 4 Jun 2007 (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 purpose of this study is to evaluate four different nasal continuous pressure systems, which are usually applied on our neonatal intensive care unit, with regard of their effect on bradycardia and desaturations in preterm infants.
Detailed description
BACKGROUND:
Apnea of prematurity (AOP) is a common problem in preterm infants. Nasal respiratory support using either Continuous Positive Airway Pressure (CPAP) or Intermittent Mandatory Ventilation (IMV) are, among others, widely used treatments. Which of the different systems is the most efficient, however, is unclear.
OBJECTIVE:
Efficiency of different CPAP systems on reducing the cumulative percentage of bradycardia and desaturation in preterm infants.
METHODS:
In a prospective, randomized, cross-over trial 32 preterm infants Infants will randomly allocated to receive nasal CPAP delivered by one of the following sys-tems: (1) a conventional IMV-System (Stephanie, Stephan GmbH, Germany with PIP 15 cmH2O, RR 10/min) delivering CPAP via short binasal prongs (Hudson RCI, USA); (2) the Infant-Flow-System (EME Ltd, Great Britain) with CPAP delivery via short binasal prongs; (3) the Infant-Flow-AdvanceTM-System used in the pressure assist mode with PIP 10 cmH2O, RR 10/min; and (4) a nasal underwater bubble CPAP with application via binasal prongs (Hudson RCI, USA).
All systems will be adjusted to achieve an approximate PEEP of 6 cm H2O. Each study lasts 24 hours, during which chest wall and abdominal movements, SaO2, tcPCO2, ECG, esopha-gus pressure and CPAP-/IMV-pressure will be recorded continuously. Infants will be studied in room air in a 15° head tilt prone position while being treated with caffeine (3mg/kg/d).
PRIMARY OUTCOME MEASURE Cumulative percentage of bradycardia (heart rate <80/min) and desaturation (SaO2 <80%) per hour.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
Who may qualify
- Ages
- Up to 14 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- gestational age at birth < 34 weeks
- postconceptional age and body weight at study ≤38 week and >1000 g
- requirement for N-CPAP to treat AOP as judged by the attending neonatologist
Key exclusion criteria (5 listed)
- congenital or chromosomal abnormalities
- acute infections
- intraventricular hemorrhage
- additional inspired oxygen to maintain pulse oximeter saturation SpO2 >92%
- patent ductus arteriosus
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 |
|---|---|---|
| Stephanie (TM), Infant Flow (TM), Infant Flow advance (TM), Bubble CPAP | Device | – |
Primary outcome
Cumulative percentage of bradycardia (heart rate <80 beats/min) and desaturation (SaO2 <80%) per hour
Time frame: one year
1 secondary outcome
- Event rates for central apneas, desaturations and bradycardias calculated as the number of respective events per hour of artefact free recording time - relative cumulative event time - baseline heart rate, respiratory rate and oxygen saturation
Time frame: one year
Results and safety
The study was stopped early (reason given: Recruiting took longer than expected due to a lack of eligible patients (very strong inclusion and exclusion criterias)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2007.
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Tirzepatide Versus Positive Airway Pressure for the Treatment of Obstructive Sleep Apnoea
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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.
Tobias Pantalitschka, MD principal investigator
University children´s hospital Tuebingen
Questions about this trial
What is this clinical trial studying?
A study testing Stephanie (TM), Infant Flow (TM), Infant Flow advance (TM), Bubble CPAP in people with Continuous Positive Airway Pressure and Apnea of Prematurity, run by University Hospital Tuebingen.
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 3 inclusion and 5 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: stopped early, as of the sponsor's last update on 24 Aug 2007. Status can change between updates, so confirm with the study contact before making plans.
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 was stopped early (reason given: Recruiting took longer than expected due to a lack of eligible patients (very strong inclusion and exclusion criterias)). Results are not available in the source record.
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?
Cumulative percentage of bradycardia (heart rate <80 beats/min) and desaturation (SaO2 <80%) per hour (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Aug 2007.