Randomized Trial Investigating Four Nasal CPAP Systems in... | NCT00482040

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

NCT00482040

Sponsor

University Hospital Tuebingen

Status

Terminated

Last Update Posted

Aug 24, 2007Estimated

Enrollment

16Actual

Phase

Not Applicable

Conditions

Continuous Positive Airway Pressure
Apnea of Prematurity
CPAP

Interventions

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

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2007

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Recruiting took longer than expected due to a lack of eligible patients (very strong inclusion and exclusion criterias)

Expanded Access Info

Start Date

Mar 2004

Primary Completion Date

Not provided

Completion Date

Jan 2006Actual

First Submitted Date

Jun 1, 2007

First Submission Date that Met QC Criteria

Jun 1, 2007

First Posted Date

Jun 4, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 23, 2007

Last Update Posted Date

Aug 24, 2007Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Name	Type	Description	Arm Group Labels	Other Names
Stephanie (TM), Infant Flow (TM), Infant Flow advance (TM), Bubble CPAP	Device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cumulative percentage of bradycardia (heart rate <80 beats/min) and desaturation (SaO2 <80%) per hour		one year

Secondary Outcomes

Measure	Description	Time Frame
- 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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

14 Weeks

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tobias Pantalitschka, MD	University children´s hospital Tuebingen	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001049	Apnea
D047928	Premature Birth

Ancestor Terms

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D012818	Signs and Symptoms, Respiratory
D012816	Signs and Symptoms

Browse Leaves

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Browse Branches

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