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

Apnea of Prematurity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00482040
• Other study ID #: CPAP-I-Study
• 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
• 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

• Apnea
• Apnea of Prematurity
• Continuous Positive Airway Pressure
• CPAP
• Premature Birth

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