- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01942525
Influence of Intrauterine Growth Restriction on Amplitude-integrated EEG in Preterm Infants
Intrauterine Growth Restriction Has an Impact on Amplitude-integrated EEG in Preterm Infants
Objective: The impact of intrauterine growth restriction (IUGR) on perinatal morbidity and long-term neurodevelopmental outcome has been published in numerous studies. Throughout this analysis, the influence of IUGR on the postnatal amplitude-integrated EEG (aEEG) in preterm infants below 30 weeks of gestation was assessed. The second concern was the correlation between the pattern of the aEEG in the first two weeks with neurodevelopmental outcome, comparing infants with and without IUGR.
Methods: Routinely assessed aEEG data of preterm infants with IUGR born below 30 weeks of gestation in the years 2005 until 2007 were analysed retrospectively according to the aEEG score (combining occurrence of sleep-wake-cycles, background activity and suspected seizure activity). Neurodevelopmental outcome was evaluated at 24 months using the Bayley Scales of Infant Development and standardized neurologic examination.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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-
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Vienna, Østrig, 1090
- Medical University Vienna
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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:
- preterm infants below 30 weeks of gestation
Exclusion Criteria:
- congenital anomalies
- severe asphyxia
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
---|---|
Intrauterine growth restriction
birth weight <10th percentile first intervention: aEEG second intervention: assessment of neurodevelopmental follow-up
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The amplitude integrated EEG was performed using a single-channel, biparietal aEEG (CFM 6000; Natus Medical Incorporated, San Carlos, CA)
Andre navne:
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Appropriate for gestation age
control group with birth weight >10th percentile first intervention: aEEG second intervention: assessment of neurodevelopmental follow-up
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The amplitude integrated EEG was performed using a single-channel, biparietal aEEG (CFM 6000; Natus Medical Incorporated, San Carlos, CA)
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
aEEG score (including background pattern, occurrence of sleep-wake-cycling and presence of seizure activity)
Tidsramme: first 14 days of life
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composite score background activity (BA), occurrence of sleep-wake-cycling (SWC) and presence of seizure activity (SA) meaning score 1= normal (normal BA, SWC yes, SA no) and score 2 and 3 = abnormal (2=abnormality in 1 category (BA, SWC or SA) and score 3= abnormality in 2 or 3 categories
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first 14 days of life
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Neurodevelopmental outcome
Tidsramme: 24 months
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composite score: Bayley Scales of Infant Development (>85= normal, <70 severely impaired, 71-84= mildly impaired) and standardized neurologic examination (normal or abnormal)
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24 months
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Morbidity, mortality and neurodevelopmental outcome of patients with IUGR compared to controls
Tidsramme: 24 months
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morbidities until discharge (Intraventricular hemorrhage, retinopathy, chronic lung disease, necrotizing enterocolitis, periventricular leucomalacia); mortality and neurodevelopmental outcome (via Bayley Scales of Infant Development >85= normal, <70 = severly impaired)
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24 months
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Katrin Klebermass-Schrehof, MD, Medical University of Vienna
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
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
- KKS-07-2013
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Kliniske forsøg med Intrauterin vækstrestriktion
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University of British ColumbiaAfsluttetIntrauterin vækstrestriktion (IUGR) | Fetal Growth Restriction (FGR)Canada
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Assistance Publique - Hôpitaux de ParisRekrutteringIntrauterin vækstrestriktion | Fetal Growth Restriction (FGR)Frankrig
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Assiut UniversityAfsluttet
-
Cairo UniversityAfsluttet
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Centre Hospitalier Universitaire de Saint EtienneSAINBIOSEAfsluttet
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Helsinki University Central HospitalAfsluttetIntrauterin præventionFinland
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Washington University School of MedicineAfsluttetIntrauterin genoplivningForenede Stater
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Kanuni Sultan Suleyman Training and Research HospitalAfsluttetIntrauterin enhedKalkun
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Instituto Valenciano de Infertilidad, IVI VALENCIAAfsluttet
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noha mohamed elzaydyUkendtSvangerskabsforebyggende anordning; IntrauterinEgypten
Kliniske forsøg med aEEG
-
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-
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-
Sang Hoon OhUkendtHjertestop | Målrettet temperaturstyringKorea, Republikken
-
Maria Angela FranceschiniEunice Kennedy Shriver National Institute of Child Health and Human Development...RekrutteringFor tidlig fødsel | Intracerebral blødning | Spædbarn, lille for svangerskabsalderen | Ekstremt lav fødselsvægtForenede Stater
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University of UtahAfsluttetIntraventrikulær blødning | For tidligt fødte spædbørnForenede Stater
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St. Justine's HospitalIkke rekrutterer endnu
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Cambridge University Hospitals NHS Foundation TrustNorfolk and Norwich University Hospitals NHS Foundation Trust; Luton and... og andre samarbejdspartnereRekrutteringNeonatale anfaldDet Forenede Kongerige