NCT01690650

Brief Summary

  • Due to the increased risk of brain damage, continuous monitoring of the cerebral oxygenation is interesting. The investigators 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 cerebral vasoconstriction after oxygen exposure is prolonged in preterm infants compared to term infants.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 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

First Submitted

Initial submission to the registry

June 20, 2011

Completed
1.2 years until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
23 days until next milestone

First Posted

Study publicly available on registry

September 24, 2012

Completed
10 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

June 20, 2011

Last Update Submit

November 6, 2013

Conditions

Response to Hyperoxia

Keywords

PretermNewbornNeonateCerebral oxygenationOxygen

Outcome Measures

Primary Outcomes (1)

  • Changes from baseline of cerebral oxygen saturation after oxygen exposure.

    Measurements will take between 30 minutes and 3 hours depending of situation. Measurements within the first 4 weeks of life. No follow-up.

Study Arms (1)

Oxygen + Cerebral NIRS

EXPERIMENTAL

Induced changes in oxygen supply (100% vs. room air). Continuously monitoring of cerebral oxygen saturation.

Drug: Oxygen

Interventions

OxygenDRUG

Oxygen exposure (100% oxygen) for 5 minutes, then 25 minutes with room air. Repeated twice. Continuously monitoring of the cerebral oxygen saturation (NIRS).5 replacements of sensor for reproducibility.

Oxygen + Cerebral NIRS

Eligibility Criteria

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

You may qualify if:

  • Newborns with a gestational age of 32-40 weeks
  • Clinically stable
  • +/- CPAP with a oxygen limit below 30%
  • Parental consent

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

Interventions

Oxygen

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

ChalcogensElementsInorganic ChemicalsGases

Study Officials

  • Ole Pryds, Professor

    Department of Paediatrics, Copenhagen University Hospital, Hvidovre

    PRINCIPAL INVESTIGATOR

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

June 20, 2011

First Posted

September 24, 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)