- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00482040
Randomized Trial Investigating Four Nasal CPAP Systems in the Management of Apnea of Prematurity
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- congenital or chromosomal abnormalities
- acute infections
- intraventricular hemorrhage
- additional inspired oxygen to maintain pulse oximeter saturation SpO2 >92%
- patent ductus arteriosus
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cumulative percentage of bradycardia (heart rate <80 beats/min) and desaturation (SaO2 <80%) per hour
Time Frame: one year
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
- 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
|
one year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Tobias Pantalitschka, MD, University Children´s Hospital Tuebingen
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CPAP-I-Study
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Apnea of Prematurity
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University of ManitobaCanadian Institutes of Health Research (CIHR); The Children's Hospital Foundation...Completed
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Children's Hospital of Fudan UniversityCompletedApnea of Prematurity
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NobelpharmaCompleted
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NICHD Neonatal Research NetworkEunice Kennedy Shriver National Institute of Child Health and Human Development...Active, not recruitingApnea of PrematurityUnited States
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Daping Hospital and the Research Institute of Surgery...Unknown
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Mednax Center for Research, Education, Quality...CompletedApnea of PrematurityUnited States
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Ain Shams UniversityUnknown
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University of MiamiThe Gerber FoundationCompletedApnea of Prematurity | Periodic Breathing | Desaturation of Blood | Central Apnea | Obstructive Apnea of NewbornUnited States
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Wyss Institute at Harvard UniversityBeth Israel Deaconess Medical Center; University of Massachusetts, WorcesterCompletedApnea of PrematurityUnited States
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McMaster UniversityNational Health and Medical Research Council, Australia; Canadian Institutes...CompletedApnea of PrematurityCanada, United States, Israel, Australia, Netherlands, United Kingdom, Switzerland, Germany, Sweden
Clinical Trials on Stephanie (TM), Infant Flow (TM), Infant Flow advance (TM), Bubble CPAP
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Hamada AhmedCompleted
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University of OuluTerminated
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University Hospital, MontpellierFisher and Paykel HealthcareUnknownHypercapnic Respiratory Failure | Acute Cardiogenic Pulmonary EdemaFrance
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Laval UniversityFonds de la Recherche en Santé du Québec; Canada Foundation for InnovationCompletedExercise | COPD | Endurance Shuttle Walking Test (Exercise at 85% of Maximal Shuttle Walking Test)Canada