Observational Study in Preterm Infants With Intracranial Hemorrhage

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01620203

Enrollment

Registered

2012-06-15

Start date

2012-06-30

Completion date

2023-11-01

Last updated

2023-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Hypoxia, Intracranial Hemorrhage, Intraventricular Hemorrhage

Keywords

Premature infants, Intracranial hemorrhage, Intraventricular hemorrhage, Cerebral oxygenation, Brain function, Cerebral perfusion

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.

Interventions

OTHERNo intervention/treatment is given

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Days to 28 Days

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026