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Regional Blood FlowPhase 2ELECTROPREMNCT00722033

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

A Phase 2 study testing 3 protocols of Indomethacin administration in people with Regional Blood Flow and Premature Birth, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages Up to 30 minutes
What is being tested?
3 protocols of Indomethacin administration
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteChile
Study dates
Aug 2008to Dec 2009
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 30 minutes
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • < 30 weeks of gestational age
  • Consent inform approved

Who cannot join

  • Known mayor malformation

Trial locations and contacts

1 site in 1 country.

Chile1 site
  • Puc, Nicu

    Santiago, Santiago Metropolitan, 833-0024

    Paulina M Toso, MD, 56-2-3546437, ptoso@med.puc.cl

    Paulina M Toso, MD

Other trials in Chile

About this study

Official title: Effect of Common Neonatal Procedures Over the Amplitude- Integrated Electroencephalography Register in <30 Weeks Preterms.

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.

Read the 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.

Being tested
3 protocols of Indomethacin administration
Keywords
preterm, aEEG, apneas, surfactant, indomethacin, aminophyline
Medical subject headings
Premature Birth, Apnea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 3 protocols of Indomethacin administrationDrug

    Also called indomethacin

    Indomethacin will consecutive be infused in 30, 60 and 120 minutes in each patient who requires it.

Study groups in NCT00722033
Study groupRoleWhat they receive
AOther< 30 weeks of gestation
Receives: Drug: 3 protocols of Indomethacin administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. aEEG voltage amplitude changes after procedures

    Measured: right after procedure

Secondary outcomes (1)
  1. aEEG amplitude voltage changes between 3 administration protocols of Indomethacin

    Measured: right after procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jul 2008 (estimated)
  2. Study startAug 2008
  3. Primary completionAug 2009 (estimated)
  4. Study completionDec 2009 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00722033
Sponsor's protocol ID
PontificiauCC
Acronym
ELECTROPREM
Status last verified
Jul 2008
First submitted
23 Jul 2008
Last updated
18 Aug 2008
Results posted
No
Data monitoring committee
No

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. doi: 10.1542/peds.112.4.855.

    PubMed 14523177
  • 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.

    PubMed 17067863

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 3 protocols of Indomethacin administration in people with Regional Blood Flow and Premature Birth, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

aEEG voltage amplitude changes after procedures (time frame: right after procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00722033, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2008.

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