Randomized Trial Investigating Four Nasal CPAP Systems in the Management of Apnea of Prematurity
NCT ID: NCT00482040
Last Updated: 2007-08-24
Study Results
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Basic Information
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TERMINATED
NA
16 participants
INTERVENTIONAL
2004-03-31
2006-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Interventions
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Stephanie (TM), Infant Flow (TM), Infant Flow advance (TM), Bubble CPAP
Eligibility Criteria
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Inclusion Criteria
* 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
* acute infections
* intraventricular hemorrhage
* additional inspired oxygen to maintain pulse oximeter saturation SpO2 \>92%
* patent ductus arteriosus
14 Weeks
ALL
No
Sponsors
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University Hospital Tuebingen
OTHER
Principal Investigators
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Tobias Pantalitschka, MD
Role: PRINCIPAL_INVESTIGATOR
University children´s hospital Tuebingen
Other Identifiers
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CPAP-I-Study
Identifier Type: -
Identifier Source: org_study_id