The Effect of Stimulating Substances on Brain Activity of Preterm Infants

Medical University of Vienna

Status: Unknown

Conditions: Apneas of Prematurity

Study type: Observational

Funder types: Other

Identifiers

NCT01344317

Nationalbankprojekt Nr.13660

Details and patient eligibility

About

Introduction: Methylxanthines and doxapram have been widely used for the treatment of apneas of prematurity. Both substances have effects on the central nervous system. While there are data available concerning the use of caffeine (the methylxanthine used at our NICU) even proposing a positive effect on neurodevelopmental outcome of very preterm infants, there are data which suggest a negative effect of the central stimulants doxapram on longterm outcome in this group of infants. Nevertheless concerning both medications only few studies have been published and only scarce data are available concerning the effect of these medications on brain activity of very preterm infants until now.

The aim of this study: is the assessment of the effect of stimulating substances on brain activity of preterm infants born below 30 weeks of gestation and their longterm neurodevelopmental follow-up.

Methods: This study is a prospective study including preterm infants born below 30 weeks of gestational age. Brain activity is measured by one-channel amplitude-integrated EEG (aEEG). The first aEEG measurement is performed without caffeine and/or doxapram medication. At least one hour of brain activity is registrated. The second measurement is done at least 24 hours after the start of caffeine and/ or doxapram treatment.

The percentage of different background patterns, the occurrence and duration of sleep-wake-cycling, and the occurrence and duration of seizures is assessed and analysed. Neurodevelopmental outcome is assessed at one and two years of corrected age by assessment of the Bayley Scales of Infant Development II and standardized clinical neurological examination.

Enrollment: 60 estimated patients

Sex: All

Ages: 23 to 30 weeks old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

see above

Exclusion criteria

• intraventricular hemorrhage
• posthaemorrhagic hydrocephalus
• cerebral infection
• cerebral malformation

Trial design

60 participants in 3 patient groups

Caffeine group

Description:

Premature infants below 30 weeks of gestation who receive Caffeine treatment

Caffeine and Doxapram group

Description:

Premature infants below 30 weeks of gestation who receive Caffeine and Doxapram treatment

Group with no treatment

Description:

Premature infants below 30 weeks of gestation with no stimulating treatment