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ID
Source
Brief title
Sponsors and support
Intervention
Outcome measures
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.
Background 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.
Study objective
Goal:
1. Defining normal electophysiologic matarution in premature infants by quantitative analysing techniques;
2. Identifying circumstances that disturb normal electrophysiologic maturation.
Study design
N/A
Intervention
Weekly polysomnography.
H. Niemarkt
Veldhoven 5500 MB
The Netherlands
+31 (0)40 8889350
H.Niemarkt@mmc.nl
H. Niemarkt
Veldhoven 5500 MB
The Netherlands
+31 (0)40 8889350
H.Niemarkt@mmc.nl
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.
Two subgoups:
A. Appropriate for gestational age infants (>p10);
B. Small for getational age infants (
Exclusion criteria
N/A
Design
Recruitment
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL718 |
| NTR-old | NTR728 |
| Other | : 001 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |