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. 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
Information provided by:
University Hospital Tuebingen

Brief 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.

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

Detailed Description:


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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single
Primary Purpose: Treatment
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

Primary Outcome Measures :
  1. Cumulative percentage of bradycardia (heart rate <80 beats/min) and desaturation (SaO2 <80%) per hour [ Time Frame: one year ]

Secondary Outcome Measures :
  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 [ Time Frame: one year ]

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Ages Eligible for Study:   up to 14 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00482040

Sponsors and Collaborators
University Hospital Tuebingen
Principal Investigator: Tobias Pantalitschka, MD University children´s hospital Tuebingen Identifier: NCT00482040     History of Changes
Other Study ID Numbers: CPAP-I-Study
First Posted: June 4, 2007    Key Record Dates
Last Update Posted: August 24, 2007
Last Verified: May 2007

Keywords provided by University Hospital Tuebingen:
Apnea of prematurity

Additional relevant MeSH terms:
Premature Birth
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications