Observational Study in Preterm Infants With Intracranial Hemorrhage

NCT01620203 | Completed

• 1 other identifier: 20120065
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intracranial Hemorrhage; Intraventricular Hemorrhage; Cerebral Hypoxia

Keywords

Premature infants; Intracranial hemorrhage; Intraventricular hemorrhage; Cerebral oxygenation; Brain function; Cerebral 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 given OTHER

Control; Intracranial Hemorrhage

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Major congenital malformations
• Birth asphyxia
• Not expected to survive

Sponsors & Collaborators

• Nelson Claure: lead

Study Sites (1)

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

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Intracranial Hemorrhages; Hypoxia, Brain; Premature Birth

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

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

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 1, 2012
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)