NCT00482040

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2004

Typical duration for not_applicable

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

June 1, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 4, 2007

Completed
Last Updated

August 24, 2007

Status Verified

May 1, 2007

First QC Date

June 1, 2007

Last Update Submit

August 23, 2007

Conditions

Continuous Positive Airway PressureApnea of PrematurityCPAP

Keywords

CPAPPretermPrematurityApnea of prematurity

Outcome Measures

Primary Outcomes (1)

  • Cumulative percentage of bradycardia (heart rate <80 beats/min) and desaturation (SaO2 <80%) per hour

    one year

Secondary Outcomes (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

    one year

Interventions

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

Eligibility Criteria

AgeUp to 14 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • congenital or chromosomal abnormalities
  • acute infections
  • intraventricular hemorrhage
  • additional inspired oxygen to maintain pulse oximeter saturation SpO2 \>92%
  • patent ductus arteriosus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

ApneaPremature Birth

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Tobias Pantalitschka, MD

    University children´s hospital Tuebingen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 1, 2007

First Posted

June 4, 2007

Study Start

March 1, 2004

Study Completion

January 1, 2006

Last Updated

August 24, 2007

Record last verified: 2007-05