Trials Sponsors Conditions Drugs Pricing

Conditions

Cerebral Hypoxia Intracranial Hemorrhage Intraventricular Hemorrhage

Keywords

Premature infantsIntracranial hemorrhageIntraventricular hemorrhageCerebral oxygenationBrain functionCerebral perfusion

Outcome Measures

Primary Outcomes (1)

Change in cerebral oxygenation
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 Outcomes (1)

Change in cerebral perfusion and function
post natal weeks 4 and 8

Study Arms (2)

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

Interventions

No intervention/treatment is givenOther

ControlIntracranial Hemorrhage

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age1 Day - 28 Days

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

Sampling MethodNon-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.

You may qualify if:

Preterm infants born between 23 and 28 weeks of gestation

Sponsors & Collaborators

Nelson Claure
Otherlead

Study Sites (1)

Holtz Children's Hospital, Jackson Memorial Hospital/University of Miami Medical Center

Miami, Florida, 33136, United States

MeSH Terms

Conditions

Intracranial HemorrhagesHypoxia, BrainPremature Birth

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsHypoxiaSigns and Symptoms, RespiratorySigns and Symptoms

Study Officials

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
PRINCIPAL INVESTIGATOR

Enrollment

27 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: CASE CONTROL
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: SPONSOR INVESTIGATOR
PI Title: Research Associate Professor of Pediatrics

Study Record Dates

First Submitted

June 5, 2012

First Posted

June 15, 2012

Study Start

June 2012

Actual (reported)

Observational Study in Preterm Infants With Intracranial Hemorrhage

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Control

Intracranial Hemorrhage

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Control

Intracranial Hemorrhage

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations