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Common Neonatal Procedures Could Affect the aEEG in <30 Weeks of Gestational Age Preterms (ELECTROPREM)

Primary Purpose

Regional Blood Flow, Premature Birth, Electroencephalography

Status
Unknown status
Phase
Phase 2
Locations
Chile
Study Type
Interventional
Intervention
3 protocols of Indomethacin administration
Sponsored by
Pontificia Universidad Catolica de Chile
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Regional Blood Flow focused on measuring preterm, aEEG, apneas, surfactant, indomethacin, aminophyline

Eligibility Criteria

undefined - 30 Minutes (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • < 30 weeks of gestational age
  • Consent inform approved

Exclusion Criteria:

  • Known mayor malformation

Sites / Locations

  • Puc, Nicu

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

A

Arm Description

< 30 weeks of gestation

Outcomes

Primary Outcome Measures

aEEG voltage amplitude changes after procedures

Secondary Outcome Measures

aEEG amplitude voltage changes between 3 administration protocols of Indomethacin

Full Information

First Posted
July 23, 2008
Last Updated
August 13, 2008
Sponsor
Pontificia Universidad Catolica de Chile
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1. Study Identification

Unique Protocol Identification Number
NCT00722033
Brief Title
Common Neonatal Procedures Could Affect the aEEG in <30 Weeks of Gestational Age Preterms
Acronym
ELECTROPREM
Official Title
Effect of Common Neonatal Procedures Over the Amplitude- Integrated Electroencephalography Register in <30 Weeks Preterms.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2008
Overall Recruitment Status
Unknown status
Study Start Date
August 2008 (undefined)
Primary Completion Date
August 2009 (Anticipated)
Study Completion Date
December 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Pontificia Universidad Catolica de Chile

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Regional Blood Flow, Premature Birth, Electroencephalography
Keywords
preterm, aEEG, apneas, surfactant, indomethacin, aminophyline

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Other
Arm Description
< 30 weeks of gestation
Intervention Type
Drug
Intervention Name(s)
3 protocols of Indomethacin administration
Other Intervention Name(s)
indomethacin
Intervention Description
Indomethacin will consecutive be infused in 30, 60 and 120 minutes in each patient who requires it.
Primary Outcome Measure Information:
Title
aEEG voltage amplitude changes after procedures
Time Frame
right after procedure
Secondary Outcome Measure Information:
Title
aEEG amplitude voltage changes between 3 administration protocols of Indomethacin
Time Frame
right after procedure

10. Eligibility

Sex
All
Maximum Age & Unit of Time
30 Minutes
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: < 30 weeks of gestational age Consent inform approved Exclusion Criteria: Known mayor malformation
Facility Information:
Facility Name
Puc, Nicu
City
Santiago
State/Province
Area Metropolitana
ZIP/Postal Code
833-0024
Country
Chile
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paulina M Toso, MD
Phone
56-2-3546437
Email
ptoso@med.puc.cl
First Name & Middle Initial & Last Name & Degree
Paulina M Toso, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
14523177
Citation
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. doi: 10.1542/peds.112.4.855.
Results Reference
background
PubMed Identifier
17067863
Citation
Hellstrom-Westas L, Rosen I. Continuous brain-function monitoring: state of the art in clinical practice. Semin Fetal Neonatal Med. 2006 Dec;11(6):503-11. doi: 10.1016/j.siny.2006.07.011. Epub 2006 Oct 24.
Results Reference
background

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Common Neonatal Procedures Could Affect the aEEG in <30 Weeks of Gestational Age Preterms

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