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

This study has been completed.
Sponsor:
Collaborator:
The Ludvig & Sara Elsass Foundation
Information provided by (Responsible Party):
Line Carøe Sørensen, Copenhagen University Hospital, Hvidovre
ClinicalTrials.gov Identifier:
NCT01690650
First received: June 20, 2011
Last updated: November 6, 2013
Last verified: November 2013
  Purpose
  • 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.

Condition Intervention
Response to Hyperoxia
Drug: Oxygen

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Oxygenation of the Neonatal Brain - a Study Using the INVOS Oximeter

Resource links provided by NLM:


Further study details as provided by Copenhagen University Hospital, Hvidovre:

Primary Outcome Measures:
  • Changes from baseline of cerebral oxygen saturation after oxygen exposure. [ Time Frame: Measurements will take between 30 minutes and 3 hours depending of situation. Measurements within the first 4 weeks of life. No follow-up. ] [ Designated as safety issue: No ]

Enrollment: 33
Study Start Date: September 2012
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Oxygen + Cerebral NIRS
Induced changes in oxygen supply (100% vs. room air). Continuously monitoring of cerebral oxygen saturation.
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.

Detailed 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.

  Eligibility

Ages Eligible for Study:   up to 4 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01690650

Locations
Denmark
Department of Paediatrics, Copenhagen University Hospital; Hvidovre
Hvidovre, Denmark, 2650
Sponsors and Collaborators
Copenhagen University Hospital, Hvidovre
The Ludvig & Sara Elsass Foundation
Investigators
Principal Investigator: Ole Pryds, Professor Department of Paediatrics, Copenhagen University Hospital, Hvidovre
  More Information

No publications provided

Responsible Party: Line Carøe Sørensen, MD, PH.D., Copenhagen University Hospital, Hvidovre
ClinicalTrials.gov Identifier: NCT01690650     History of Changes
Other Study ID Numbers: Oxygen - HH 527
Study First Received: June 20, 2011
Last Updated: November 6, 2013
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by Copenhagen University Hospital, Hvidovre:
Preterm
Newborn
Neonate
Cerebral oxygenation
Oxygen

Additional relevant MeSH terms:
Hyperoxia
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on July 22, 2014