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

C

Copenhagen University Hospital, Hvidovre

Status

Completed

Conditions

Response to Hyperoxia

Treatments

Drug: Oxygen

Study type

Interventional

Funder types

Other

Identifiers

NCT01690650
Oxygen - HH 527

Details and patient eligibility

About

* 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.

Full 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.

Enrollment

33 patients

Sex

All

Ages

1 hour to 4 weeks old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

33 participants in 1 patient group

Oxygen + Cerebral NIRS
Experimental group
Description:
Induced changes in oxygen supply (100% vs. room air). Continuously monitoring of cerebral oxygen saturation.
Treatment:
Drug: Oxygen

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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