Observational Study in Preterm Infants With Intracranial Hemorrhage

Completed

• Conditions: Intracranial Hemorrhage; Intraventricular Hemorrhage; Cerebral Hypoxia
• Interventions: Other: No intervention/treatment is given

• Registration Number: NCT01620203
• Lead Sponsor: Nelson Claure

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-06-05
• Study First Submitted QC: 2012-06-12
• Study First Posted: 2012-06-15
• Status Verified: 2023-11
• Primary Completion: 2023-11-01
• Study Completion: 2023-11-01
• Last Update Submitted: 2023-11-16
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change in cerebral oxygenation	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

Name	Time	Method
Change in cerebral perfusion and function	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.

Trial Locations

Locations (1)

Holtz Children's Hospital, Jackson Memorial Hospital/University of Miami Medical Center; 🇺🇸 Miami, Florida, United States