Randomized Trial Investigating Four Nasal CPAP Systems in the Management of Apnea of Prematurity
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00482040|
Recruitment Status : Terminated (Recruiting took longer than expected due to a lack of eligible patients (very strong inclusion and exclusion criterias))
First Posted : June 4, 2007
Last Update Posted : August 24, 2007
|Condition or disease||Intervention/treatment||Phase|
|Continuous Positive Airway Pressure Apnea of Prematurity CPAP||Device: Stephanie (TM), Infant Flow (TM), Infant Flow advance (TM), Bubble CPAP||Not Applicable|
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.
Efficiency of different CPAP systems on reducing the cumulative percentage of bradycardia and desaturation in preterm infants.
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||Randomized Trial Investigating Four Nasal CPAP Systems in the Management of Apnea of Prematurity|
|Study Start Date :||March 2004|
|Actual Study Completion Date :||January 2006|
- Cumulative percentage of bradycardia (heart rate <80 beats/min) and desaturation (SaO2 <80%) per hour [ Time Frame: one year ]
- - 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00482040
|Principal Investigator:||Tobias Pantalitschka, MD||University children´s hospital Tuebingen|