Observational Study in Preterm Infants With Intracranial Hemorrhage

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of Miami
Sponsor:
Information provided by (Responsible Party):
Nelson Claure, University of Miami
ClinicalTrials.gov Identifier:
NCT01620203
First received: June 5, 2012
Last updated: March 7, 2014
Last verified: March 2014
  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 University of Miami:

Primary Outcome Measures:
  • Progression of cerebral oxygenation [ Time Frame: postnatal weeks 1, 4 and 8 ] [ Designated as safety issue: No ]
    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:
  • Progression of cerebral perfusion and function [ Time Frame: post natal weeks 1, 4 and 8 ] [ Designated as safety issue: No ]
    Comparisons of ultrasound measurements of superior vena cava flow, brain electrical activity by electroencephalography and auditory brainstem responses over time in infants with ICH and non-ICH infants.


Estimated Enrollment: 40
Study Start Date: June 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (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

Ages Eligible for Study:   up to 7 Days
Genders Eligible for Study:   Both
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 24 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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: Nao Sasaki, M.D. University of Miami
  More Information

No publications provided

Responsible Party: Nelson Claure, Research Associate Professor of Pediatrics, University of Miami
ClinicalTrials.gov Identifier: NCT01620203     History of Changes
Other Study ID Numbers: 20120065
Study First Received: June 5, 2012
Last Updated: March 7, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on August 28, 2014