Neonatal Cerebral Oxygenation After Exposure to Oxygen Evaluated With the INVOS Oximeter

Response to Hyperoxia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01690650
• Other study ID #: Oxygen - HH 527
• Status: Completed
• Phase: N/A
• First received: June 20, 2011
• Last updated: November 6, 2013
• Start date: September 2012
• Est. completion date: August 2013

Study information

• Verified date: November 2013
• Source: Copenhagen University Hospital, Hvidovre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 4 Weeks

Eligibility

Inclusion Criteria:

• Newborns with a gestational age of 32-40 weeks

• Clinically stable

• +/- CPAP with a oxygen limit below 30%

• Parental consent

Exclusion Criteria:

• Severe birth asphyxia

• Prohibition of oxygen exposure

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Response to Hyperoxia

Intervention

Drug:
• Oxygen
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.

Locations

Country	Name	City	State
Denmark	Department of Paediatrics, Copenhagen University Hospital; Hvidovre	Hvidovre

Sponsors (2)

Lead Sponsor	Collaborator
Copenhagen University Hospital, Hvidovre	The Ludvig & Sara Elsass Foundation

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No