Completed

Oxygenation of the Neonatal Brain - a Study Using the INVOS Oximeter

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What is being tested

Oxygen

Drug
Who is being recruted

Urogenital Diseases+3

+ Female Urogenital Diseases and Pregnancy Complications

+ Obstetric Labor Complications

+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Basic Science Study

Interventional
Study Start: September 2012
See protocol details

Summary

Principal SponsorCopenhagen University Hospital, Hvidovre
Last updated: November 8, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2012

Actual date on which the first participant was enrolled.

Preterm infants are at increased risk of brain damage compared with term infants, and cerebral hypoxia is considered to have an important role. The preterm infants are at increased risk of respiratory distress, episodes with low oxygenation, mechanical ventilation, risk of hypocapnia and labile or low blood pressure. These conditions can affect the microcirculation and hence the oxygenation of the brain. Hyperoxia is also a point of interest, since high levels of oxygen can cause vasoconstriction. The investigators will examine the normal physiological cerebral response to exposure of oxygen in a group of preterm infants with a gestational age (GA) of 32-37 weeks and a group of term infants. The investigators will do dynamic research with continuously monitoring of the cerebral oxygenation using the INVOS® Cerebral/Somatic Oximeter (Near InfraRed Spectroscopy (NIRS)). Reproducibility is examined by repeated measurements. There will be no follow-up.

NCT01690650
Principal SponsorCopenhagen University Hospital, Hvidovre
Last updated: November 8, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

33 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsObstetric Labor ComplicationsObstetric Labor, PrematurePregnancy ComplicationsPremature Birth

Criteria

4 inclusion criteria required to participate
/- CPAP with a oxygen limit below 30%
Clinically stable
Newborns with a gestational age of 32-40 weeks
Parental consent
2 exclusion criteria prevent from participating
Prohibition of oxygen exposure
Severe birth asphyxia

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Department of Paediatrics, Copenhagen University Hospital; Hvidovre

Hvidovre, DenmarkOpen Department of Paediatrics, Copenhagen University Hospital; Hvidovre in Google Maps
CompletedOne Study Center