Common Neonatal Procedures Could Affect the aEEG in <30 Weeks of Gestational Age Preterms (ELECTROPREM)
|ClinicalTrials.gov Identifier: NCT00722033|
Recruitment Status : Unknown
Verified July 2008 by Pontificia Universidad Catolica de Chile.
Recruitment status was: Not yet recruiting
First Posted : July 25, 2008
Last Update Posted : August 18, 2008
|Condition or disease||Intervention/treatment||Phase|
|Regional Blood Flow Premature Birth Electroencephalography||Drug: 3 protocols of Indomethacin administration||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of Common Neonatal Procedures Over the Amplitude- Integrated Electroencephalography Register in <30 Weeks Preterms.|
|Study Start Date :||August 2008|
|Estimated Primary Completion Date :||August 2009|
|Estimated Study Completion Date :||December 2009|
< 30 weeks of gestation
Drug: 3 protocols of Indomethacin administration
Indomethacin will consecutive be infused in 30, 60 and 120 minutes in each patient who requires it.
Other Name: indomethacin
- aEEG voltage amplitude changes after procedures [ Time Frame: right after procedure ]
- aEEG amplitude voltage changes between 3 administration protocols of Indomethacin [ Time Frame: right after procedure ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00722033
|Santiago, Area Metropolitana, Chile, 833-0024|
|Contact: Paulina M Toso, MD 56-2-3546437 firstname.lastname@example.org|
|Principal Investigator: Paulina M Toso, MD|