Studies on electrophysiologic maturation of the premature brain: small for gestational infants and appropriate for gestational age infants.|
|- candidate number||2160|
|- NTR Number||NTR728|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||7-jul-2006|
|- Secondary IDs||001 |
|- Public Title||Studies on electrophysiologic maturation of the premature brain: small for gestational infants and appropriate for gestational age infants.|
|- Scientific Title||Studies on electrophysiologic maturation of the premature brain: small for gestational infants and appropriate for gestational age infants.|
1. Defining normal electophysiologic matarution in premature infants by quantitative analysing techniques;
2. Identifying circumstances that disturb normal electrophysiologic maturation.
|- Healt Condition(s) or Problem(s) studied|
|- Inclusion criteria||Premature infants:|
1. Gestational Age <30 weeks;
2. Cardiorespiratory stabile;
3. No major lesions on cerebral ultrasound;
4. No abnormalities on neurologic examination.
A. Appropriate for gestational age infants (>p10);
B. Small for getational age infants (
|- Exclusion criteria||N/A|
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||1-jul-2006|
|- planned closingdate||1-jul-2007|
|- Target number of participants||45|
|- Interventions||Weekly polysomnography.
|- Primary outcome||Quantitive analysis of EEG data:|
i.e. Burst lenght, interburst length, quantitative aspects of bursts.
|- Secondary outcome||Follow up examinations at 2 years and 6 years of age.|
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||MD. H. Niemarkt|
|- CONTACT for SCIENTIFIC QUERIES||Dr. S. Bambang Oetomo|
|- Sponsor/Initiator |
(Source(s) of Monetary or Material Support)
|Máxima Medical Center|
|- Brief summary||In order to prevent adverse neurological outcome in very low birth weight infants, insight in normal brain development and identification of circumstances that damage normal brain development is warranted. Polysomnographic patterns reflect functional brain maturation and are correlated with neurological outcome in preterm infants. |
Because of the expertise at the Maxima Medical Centre in signal analysis (in collaboration with researchers of the Technical University Eindhoven), we intend to document “normal” neuroelektrophysiologic development in preterm infants by polysomnography and quantitative analysis of the acquired data, in order to identify potential damaging influences on this development.
During an open observational, non-invasive, non-therapeutic study of a cohort population we will perform weekly polysomnography recordings.
In this first study we will explore electrophysiologic maturation in appropriate for gestational age (AGA) infants and small for gestational infants (SGA) with brain sparing.
|- Main changes (audit trail)|
|- RECORD||7-jul-2006 - 1-dec-2009|
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