CompletedNot Applicable

Observational Study in Preterm Infants With Intracranial Hemorrhage

United States27 participantsStarted 2012-06

Plain-language 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.

Who can participate

Age range1 Day – 28 Days

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change in cerebral oxygenation

Timeframe: postnatal weeks 4 and 8

Trial details

NCT IDNCT01620203

SponsorNelson Claure

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-11-01

View on ClinicalTrials.gov More Intracranial Hemorrhage trials