Observational Study in Preterm Infants With Intracranial Hemorrhage

Intraventricular Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01620203
• Other study ID #: 20120065
• Status: Completed
• Start date: June 2012
• Est. completion date: November 1, 2023

Study information

• Verified date: November 2023
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: November 1, 2023
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 28 Days

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Hypoxia
• Hemorrhage
• Hypoxia
• Hypoxia, Brain
• Intracranial Hemorrhage
• Intracranial Hemorrhages
• Intraventricular Hemorrhage

Intervention

Other:
• No intervention/treatment is given

Locations

Country	Name	City	State
United States	Holtz Children's Hospital, Jackson Memorial Hospital/University of Miami Medical Center	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Nelson Claure

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in cerebral perfusion and function	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