Observational Study in Preterm Infants With Intracranial Hemorrhage

November 16, 2023 updated by: Nelson Claure

Observational Study in Preterm Infants With and Without Intracranial Hemorrhage: Longitudinal Assessment of Cerebral Oxygenation, Perfusion and Function

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

27

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • Holtz Children's Hospital, Jackson Memorial Hospital/University of Miami Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 4 weeks (Child)

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control
Matched group of control infants without diagnosis of intracranial hemorrhage
Other: No intervention/treatment is given
Intracranial Hemorrhage
Group of preterm infant with diagnosis of intracranial hemorrhage.
Other: No intervention/treatment is given

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
postnatal weeks 4 and 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
post natal weeks 4 and 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nelson Claure

Investigators

  • Principal Investigator: Nelson Claure, M.Sc.,Ph.D., University of Miami
  • Principal Investigator: Deepak Jain, M.D., University of Miami
  • Principal Investigator: Sethuraman Swaminathan, M.D., University of Miami
  • Principal Investigator: Eduardo Bancalari, M.D., University of Miami

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2012

Primary Completion (Actual)

November 1, 2023

Study Completion (Actual)

November 1, 2023

Study Registration Dates

First Submitted

June 5, 2012

First Submitted That Met QC Criteria

June 12, 2012

First Posted (Estimated)

June 15, 2012

Study Record Updates

Last Update Posted (Estimated)

November 20, 2023

Last Update Submitted That Met QC Criteria

November 16, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20120065

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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