- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01344317
The Effect of Stimulating Substances on Brain Activity of Preterm Infants
The Effect of Stimulating Substances on Brain Activity Measured by Amplitude-integrated EEG and Long-term Neurodevelopmental Outcome of Preterm Infants Born Below 30 Weeks of Gestation
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.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiesteder
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Vienna, Østrig, 1090
- Medical University of Vienna
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Vienna, Østrig, 1090
- Medical University of Vienna, Department of Pediatrics and Adolescent Medicine, Neonatology
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
see above
Exclusion Criteria:
- intraventricular hemorrhage
- posthaemorrhagic hydrocephalus
- cerebral infection
- cerebral malformation
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kohorte
- Tidsperspektiver: Fremadrettet
Kohorter og interventioner
Gruppe / kohorte |
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Caffeine group
Premature infants below 30 weeks of gestation who receive Caffeine treatment
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Caffeine and Doxapram group
Premature infants below 30 weeks of gestation who receive Caffeine and Doxapram treatment
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Group with no treatment
Premature infants below 30 weeks of gestation with no stimulating treatment
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Manfred Weninger, MD, PhD, Medical University of Vienna
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Nationalbankprojekt Nr.13660
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