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NCT Number: NCT01620203

Observational Study in Preterm Infants With Intracranial Hemorrhage

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.

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Key information

Conditions

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

Age range

1 day–28 day

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention/treatment is given

Other

Primary outcomes

  1. Change in cerebral oxygenation

    Time frame: 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 outcomes

  1. Change in cerebral perfusion and function

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Nelson Claure

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2023
Study completion
2023
First posted
Jun 15, 2012
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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