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Observational Study in Preterm Infants With Intracranial Hemorrhage

This study is currently recruiting participants.
Verified October 2017 by Nelson Claure, University of Miami
Sponsor:
ClinicalTrials.gov Identifier:
NCT01620203
First Posted: June 15, 2012
Last Update Posted: October 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Nelson Claure, University of Miami
  Purpose

Intracranial Hemorrhage (ICH) is an important morbidity affecting premature infants and can have considerable effects on neurodevelopmental outcome.

The investigators showed that preterm infants with severe ICH have decreased cerebral oxygenation several weeks after the hemorrhage. The mechanisms involved in this state of decreased cerebral oxygenation in preterm infants and the effects on cerebral function are unknown.

This longitudinal observation study will evaluate physiologic parameters to determine trends in cerebral oxygenation and function in preterm infants with ICH in comparison to infants without ICH.


Condition
Intracranial Hemorrhage Intraventricular Hemorrhage Cerebral Hypoxia

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Observational Study in Preterm Infants With and Without Intracranial Hemorrhage: Longitudinal Assessment of Cerebral Oxygenation, Perfusion and Function

Resource links provided by NLM:


Further study details as provided by Nelson Claure, University of Miami:

Primary Outcome Measures:
  • Change in cerebral oxygenation [ Time Frame: postnatal weeks 4 and 8 ]
    Comparison of the progression of cerebral oxygenation measured non-invasively by near infrared spectroscopy over time in infants with ICH and non-ICH infants.


Secondary Outcome Measures:
  • Change in cerebral perfusion and function [ Time Frame: post natal weeks 4 and 8 ]
    Comparisons of ultrasound measurements of superior vena cava flow and brain electrical activity by electroencephalography over time in infants with ICH and non-ICH infants.


Estimated Enrollment: 40
Study Start Date: June 2012
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
Control
Matched group of control infants without diagnosis of intracranial hemorrhage
Intracranial Hemorrhage
Group of preterm infant with diagnosis of intracranial hemorrhage.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Preterm infants admitted to the newborn intensive care unit at Holtz Children's Hospital of the Jackson Memorial Hospital/University of Miami Medical Center.
Criteria

Inclusion Criteria:

  • Preterm infants born between 23 and 28 weeks of gestation
  • Diagnosed with ICH grades II or higher during the first week after birth
  • Matched control infants without ICH.

Exclusion Criteria:

  • Major congenital malformations
  • Birth asphyxia
  • Not expected to survive
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01620203


Contacts
Contact: Nelson Claure, M.Sc., Ph.D. 3055856408 nclaure@miami.edu
Contact: Carmen D'Ugard, M.D., R.R.T. 305856404 cdugard@med.miami.edu

Locations
United States, Florida
Holtz Children's Hospital, Jackson Memorial Hospital/University of Miami Medical Center Recruiting
Miami, Florida, United States, 33136
Sponsors and Collaborators
Nelson Claure
Investigators
Principal Investigator: Nelson Claure, M.Sc.,Ph.D. University of Miami
Principal Investigator: Eduardo Bancalari, M.D. University of Miami
Principal Investigator: Deepak Jain, M.D. University of Miami
Principal Investigator: Sethuraman Swaminathan, M.D. University of Miami
  More Information

Responsible Party: Nelson Claure, Research Associate Professor of Pediatrics, University of Miami
ClinicalTrials.gov Identifier: NCT01620203     History of Changes
Other Study ID Numbers: 20120065
First Submitted: June 5, 2012
First Posted: June 15, 2012
Last Update Posted: October 11, 2017
Last Verified: October 2017

Keywords provided by Nelson Claure, University of Miami:
Premature infants
Intracranial hemorrhage
Intraventricular hemorrhage
Cerebral oxygenation
Brain function
Cerebral perfusion

Additional relevant MeSH terms:
Hypoxia
Cerebral Hemorrhage
Hypoxia, Brain
Brain Diseases
Hemorrhage
Intracranial Hemorrhages
Pathologic Processes
Signs and Symptoms, Respiratory
Signs and Symptoms
Cerebrovascular Disorders
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases