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

NCT00722033 | Unknown Phase 2

• 1 other identifier: PontificiauCC
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Regional Blood Flow; Premature Birth; Electroencephalography

Keywords

preterm; aEEG; apneas; surfactant; indomethacin; aminophyline

Outcome Measures

Primary Outcomes (1)

• aEEG voltage amplitude changes after procedures

  right after procedure

Secondary Outcomes (1)

• aEEG amplitude voltage changes between 3 administration protocols of Indomethacin

  right after procedure

Study Arms (1)

A

OTHER

\< 30 weeks of gestation

Drug: 3 protocols of Indomethacin administration

Interventions

3 protocols of Indomethacin administration DRUG

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

Also known as: indomethacin

A

Eligibility Criteria

• Age: Up to 30 Minutes
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \< 30 weeks of gestational age
• Consent inform approved

You may not qualify if:

• Known mayor malformation

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead

Study Sites (1)

Puc, Nicu

Santiago, Santiago Metropolitan, 833-0024, Chile

Location

Related Publications (2)

• 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.

  PMID: 14523177 BACKGROUND

• 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.

  PMID: 17067863 BACKGROUND

MeSH Terms

Conditions

Premature Birth; Apnea

Interventions

Indomethacin

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 23, 2008
• First Posted: July 25, 2008
• Study Start: August 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: December 1, 2009
• Last Updated: August 18, 2008

Record last verified: 2008-07

Locations

CL (1)