Common Neonatal Procedures Could Affect the aEEG in <30 Weeks of Gestational Age Preterms
Information source: Pontificia Universidad Catolica de Chile
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Regional Blood Flow; Premature Birth; Electroencephalography
Intervention: 3 protocols of Indomethacin administration (Drug)
Phase: Phase 2
Status: Not yet recruiting
Sponsored by: Pontificia Universidad Catolica de Chile
Summary
Very low birth weight infants has increased dramatically their survival. Survival without
neurologic disturbance varies a lot between centers. There is evidence that fluctuations in
cerebral blood flow influences the appearance of intraventricular hemorrhage and itself
implies a detrimental neurologic developing. The electroencephalography is the result of
electric base membrane activity on rest, and it's influenced by the blood flow either. The
Amplitude-integrated electroencephalography is a novel tool, that is capable to be
continuously used at the patient bed and is easily to be read by the trained clinician. The
hypothesis is that common procedures as Surfactant instilation, Indomethacin and Aminophyline
infusion as the appearance of apneas alters the aEEG register. It is a prospective study that
tries to recruit 10 < 30 weeks of gestational age with aprofen consent to monitorize the aEEG
since birth to the seventh day of live.
Clinical Details
Official title: Effect of Common Neonatal Procedures Over the Amplitude- Integrated Electroencephalography Register in <30 Weeks Preterms.
Study design: Diagnostic, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment
Primary outcome: aEEG voltage amplitude changes after procedures
Secondary outcome: aEEG amplitude voltage changes between 3 administration protocols of Indomethacin
Detailed description:
The survival of extreme premature babies ( < 1000 grams) has improved in the last years. The
neonatal networks have realized of these results and of the interventions associated with
better forecast in the managing of certain punctual problems. Also they have informed that
differences exist in the results obtained among the centers credited for the managing of this
type of patients. One of the challenges of the current Neonatology is the survival without
sequels.
It is of principal worry the neurological sequels in the extreme premature babies. These can
go from severe alterations up to minimal disorders. The managing of the critical patient
includes the strict and continuous monitoring of the vital signs. The cerebral function is of
evaluation limited in the acute period of these patients. The electroencephalography is the
expression of the membrane potential in rest neuronal. One has seen that the changes in
cerebral flow affect the electrical sign emitted by this one. There have been reported that
some conditions that in the neonatal period are associated with alterations of cerebral flow.
This way there is described, that the application of surfactant is associated with
fluctuations of the cerebral flow, the arterial unbalanced ductus, Indomethacin's injection
in less than 30 minutes, episodes of severe hypoxemia , Methylxanthines's injection,etc.
For some years there is used the Monitoring of Amplitude-Integrated Electroencephalography to
term newborn. It corresponds to the Electroencephalography sign obtained in C3 and C4
location of the standard electroencephalography, amplification of the sign, filtered to
2-15Hz, submitted to a semilogarithmic compression of the extent rectified by a constant of
time of 0,5 seconds and compressed. This gives origin to different patterns, possible to
interpret for the clinician in real time. The use of this tool in premature babies is still
experimental.
It is tried to evaluate if common procedures theorically associated with alteration of the
cerebral flow, in extreme premature babies affect the Amplitude- Integrated
Electroencephalography record. It will measure up if changes happen to relation to the
application of Surfactant, Indomethacin in 3 rate of application and Aminophyline's infusion.
The effect of desaturation will measure up, bradycardias and apneas in the extent of
voltage.
For this they will be monitored in continuous form from the birth to 10 premature babies <30
weeks of gestational age for 7 days, previous obtaining of informed consent. Protocols will
be applied: quality of sign and specifics according to the raised aims. The analysis will be
done by means of programs EEG Viewer and Chart Analyzer. The analysis of the bosses of aEEG
and of his variations will be realized manually, applying the Burdjalov and Spitzer score.
The periods before, during and after the administration of Surfactant, Indomethacin and
Aminophyline were selected . In case of apneas, bradycardias and desaturation it will be
compared 1 minute before with the properly such episode. These episodes will be transfer to
an Excel schedule for his numerical analysis. This will allow the obtaining of averages and
standard diversion of the extent of voltage of every episode and it's going to be calculated
if there is any difference before and after each episode. The same is going to be done for
Surfactant (5 minutes before and after), Indometacin(30 minutes before and during the 3 rates
of infusion) and Aminophyline(15 minutes before and after) The level of statistics
significance for all the test will be p < 0,05.
One expects to achieve ideal quality of sign > 75 % of the registered time. One tries to
evaluate 12 Surfactant applications, 35 of Indomethacin, 60 of Aminophyline and 100
cardiorespiratory events. One expects to find differences in the Extent of voltage in
relation to desaturations, bradycardias and apneas.
Eligibility
Minimum age: N/A.
Maximum age: 30 Minutes.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- < 30 weeks of gestational age
- Consent inform approved
Exclusion Criteria:
- Known mayor malformation
Locations and Contacts
PUC, NICU, Santiago, Area Metropolitana 833-0024, Chile
Additional Information
Related publications: Burdjalov VF, Baumgart S, Spitzer AR. Cerebral function monitoring: a new scoring system for the evaluation of brain maturation in neonates. Pediatrics. 2003 Oct;112(4):855-61. Hellström-Westas L, Rosén I. Continuous brain-function monitoring: state of the art in clinical practice. Semin Fetal Neonatal Med. 2006 Dec;11(6):503-11. Epub 2006 Oct 24. Review.
Starting date: August 2008
Ending date: December 2009
Last updated: August 13, 2008
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