NCT01684618

Brief Summary

  • Due to the increased risk of brain damage, continuous monitoring of the cerebral oxygenation is interesting. We will evaluate the capability of the INVOS Oximeter to detect induced changes in the cerebral regional saturation.
  • The purpose of the study is to investigate our hypothesis that a particular CPAP flow pressure optimizes the regional cerebral oxygenation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2012

Geographic Reach
1 country

1 active site

Status
completed

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

September 1, 2012

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

September 11, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 13, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

November 8, 2013

Status Verified

November 1, 2013

Enrollment Period

11 months

First QC Date

September 11, 2012

Last Update Submit

November 6, 2013

Conditions

Cerebral Oxygenation

Keywords

PretermNeonateNewbornCerebral oxygenationCPAP

Outcome Measures

Primary Outcomes (1)

  • Changes in regional cerebral oxygen saturation, rSO2, during induced changes in CPAP flow pressure

    Measurements will take between 30 minutes and 3 hours depending of situation. Within the first 4 weeks of life.

Study Arms (1)

Cerebral NIRS oximetry + CPAP

EXPERIMENTAL

Cerebral NIRS oximetry, using the INVOS Cerebral/Somatic Oximeter, and changes in regional cerebral oxygen saturation, rSO2, during induced changes in CPAP flow pressure

Procedure: Cerebral NIRS Oximetry + CPAP

Interventions

Cerebral NIRS Oximetry + CPAPPROCEDURE

CPAP flow pressure is increased for 5 minutes then 15 minutes with CPAP pressure at baseline. Repeated once

Also known as: INVOS 5100C Oximeter
Cerebral NIRS oximetry + CPAP

Eligibility Criteria

Age1 Hour - 4 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may not qualify if:

  • Severe birth asphyxia - Prohibition of oxygen exposure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Paediatrics, Copenhagen University Hospital; Hvidovre

Hvidovre, 2650, Denmark

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PH.D.

Study Record Dates

First Submitted

September 11, 2012

First Posted

September 13, 2012

Study Start

September 1, 2012

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

November 8, 2013

Record last verified: 2013-11

Locations

DK(1)