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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00482040
Other study ID # CPAP-I-Study
Secondary ID
Status Terminated
Phase N/A
First received June 1, 2007
Last updated August 23, 2007
Start date March 2004
Est. completion date January 2006

Study information

Verified date May 2007
Source University Hospital Tuebingen
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 16
Est. completion date January 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A to 14 Weeks
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
Stephanie (TM), Infant Flow (TM), Infant Flow advance (TM), Bubble CPAP


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University Hospital Tuebingen

Outcome

Type Measure Description Time frame Safety issue
Primary Cumulative percentage of bradycardia (heart rate <80 beats/min) and desaturation (SaO2 <80%) per hour one year
Secondary - 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 one year
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