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NCT Number: NCT01684618

Neonatal Cerebral Oxygenation and Changes in CPAP Flow Pressure - Evaluation With INVOS Oximeter

* Due to the increased risk of brain damage, continuous monitoring of the cerebral oxygenation is interesting. We 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 a particular CPAP flow pressure optimizes the regional cerebral oxygenation.

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Key information

Conditions

Cerebral Oxygenation Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

1 hour–4 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Paediatrics, Copenhagen University Hospital; Hvidovre

Hvidovre, 2650, Denmark

About this study

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. Preterm infants is often treated with CPAP (Continuous positive airway pressure), but the effect of different flow pressures on the regional cerebral oxygenation is not known.

The investigators will examine the normal physiological response of the brain in a group of preterm infants with a gestational age (GA) of 32-37 weeks and a group of term infants to the commonly used treatment in neonatology, CPAP (Continuous positive airway pressure).

The investigators will do dynamic research with continuously monitoring of the cerebral oxygenation using the INVOS® Cerebral/Somatic Oximeter (Near InfraRed Spectroscopy (NIRS)). INVOS® is the first NIRS-based oximeter CE-approved for hospital use in Denmark.

There will be no follow-up.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion 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

Treatment and study plan

Cerebral NIRS Oximetry + CPAP

Procedure

CPAP flow pressure is increased for 5 minutes then 15 minutes with CPAP pressure at baseline. Repeated once

Other names: INVOS 5100C Oximeter

Primary outcomes

  1. Changes in regional cerebral oxygen saturation, rSO2, during induced changes in CPAP flow pressure

    Time frame: Measurements will take between 30 minutes and 3 hours depending of situation. Within the first 4 weeks of life.

Sponsors and collaborators

Lead sponsor

Copenhagen University Hospital, Hvidovre

Other

Collaborators

  • The Ludvig & Sara Elsass Foundation

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Sep 13, 2012
Registry last updated
Nov 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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