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Studies on electrophysiologic maturation of the premature brain: small for gestational infants and appropriate for gestational age infants.


- candidate number2160
- NTR NumberNTR728
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR7-jul-2006
- Secondary IDs001 
- Public TitleStudies on electrophysiologic maturation of the premature brain: small for gestational infants and appropriate for gestational age infants.
- Scientific TitleStudies on electrophysiologic maturation of the premature brain: small for gestational infants and appropriate for gestational age infants.
- ACRONYMN/A
- hypothesisGoal:
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 criteriaPremature infants:
1. Gestational Age <30 weeks;
2. Cardiorespiratory stabile;
3. No major lesions on cerebral ultrasound;
4. No abnormalities on neurologic examination.


Two subgoups:
A. Appropriate for gestational age infants (>p10);
B. Small for getational age infants (
- Exclusion criteriaN/A
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type2 or more arms, non-randomized
- Studytypeintervention
- planned startdate 1-jul-2006
- planned closingdate1-jul-2007
- Target number of participants45
- InterventionsWeekly polysomnography.
- Primary outcomeQuantitive analysis of EEG data:
i.e. Burst lenght, interburst length, quantitative aspects of bursts.
- Secondary outcomeFollow up examinations at 2 years and 6 years of age.
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESMD. H. Niemarkt
- CONTACT for SCIENTIFIC QUERIESDr. S. Bambang Oetomo
- Sponsor/Initiator
- Funding
(Source(s) of Monetary or Material Support)
Máxima Medical Center
- PublicationsN/A
- Brief summaryIn 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)
- RECORD7-jul-2006 - 1-dec-2009


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