Randomized Trial Investigating Four Nasal CPAP Systems in the Management of Apnea of Prematurity

This study has been terminated.
(Recruiting took longer than expected due to a lack of eligible patients (very strong inclusion and exclusion criterias))
Sponsor:
Information provided by:
University Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT00482040
First received: June 1, 2007
Last updated: August 23, 2007
Last verified: May 2007
  Purpose

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 Intervention
Continuous Positive Airway Pressure
Apnea of Prematurity
CPAP
Device: Stephanie (TM), Infant Flow (TM), Infant Flow advance (TM), Bubble CPAP

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Randomized Trial Investigating Four Nasal CPAP Systems in the Management of Apnea of Prematurity

Resource links provided by NLM:


Further study details as provided by University Hospital Tuebingen:

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

Secondary Outcome Measures:
  • - 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 ]

Enrollment: 16
Study Start Date: March 2004
Study Completion Date: January 2006
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.

  Eligibility

Ages Eligible for Study:   up to 14 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00482040

Sponsors and Collaborators
University Hospital Tuebingen
Investigators
Principal Investigator: Tobias Pantalitschka, MD University children´s hospital Tuebingen
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00482040     History of Changes
Other Study ID Numbers: CPAP-I-Study
Study First Received: June 1, 2007
Last Updated: August 23, 2007
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University Hospital Tuebingen:
CPAP
Preterm
Prematurity
Apnea of prematurity

Additional relevant MeSH terms:
Apnea
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on September 30, 2014