Intracranial HemorrhageNCT01620203
Observational Study in Preterm Infants With Intracranial Hemorrhage
An observational study of Intracranial Hemorrhage and Intraventricular Hemorrhage, run by Nelson Claure at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 1 day to 28 days
- Conditions the study is for
- Intracranial Hemorrhage, Intraventricular Hemorrhage, Cerebral Hypoxia
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to 1 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 28 days
- All sexes
- No healthy volunteers
- Child
Study population: Preterm infants admitted to the newborn intensive care unit at Holtz Children's Hospital of the Jackson Memorial Hospital/University of Miami Medical Center.
Who may be able to join
- 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.
Who cannot join
- Major congenital malformations
- Birth asphyxia
- Not expected to survive
Trial locations and contacts
1 site in 1 country.
United States1 site
Holtz Children's Hospital, Jackson Memorial Hospital/University of Miami Medical Center
Miami, Florida, 33136
About this study
Official title: Observational Study in Preterm Infants With and Without Intracranial Hemorrhage: Longitudinal Assessment of Cerebral Oxygenation, Perfusion and Function
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.
- Being tested
- No intervention/treatment is given
- Keywords
- Premature infants, Intracranial hemorrhage, Intraventricular hemorrhage, Cerebral oxygenation, Brain function, Cerebral perfusion
- Medical subject headings
- Intracranial Hemorrhages, Hypoxia, Brain, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention/treatment is givenOther
| Study group | Role | What they receive |
|---|---|---|
| Control | Matched group of control infants without diagnosis of intracranial hemorrhage Receives: Other: No intervention/treatment is given | |
| Intracranial Hemorrhage | Group of preterm infant with diagnosis of intracranial hemorrhage. Receives: Other: No intervention/treatment is given |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: postnatal weeks 4 and 8
Secondary outcomes (1)
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.
Measured: post natal weeks 4 and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2012 (estimated)
- Study startJun 2012
- Primary completion1 Nov 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nelson Claure
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nelson Claure, University of Miami
- Investigators
- Nelson Claure, M.Sc.,Ph.D., Principal investigator, University of MiamiEduardo Bancalari, M.D., Principal investigator, University of MiamiDeepak Jain, M.D., Principal investigator, University of MiamiSethuraman Swaminathan, M.D., Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01620203
- Sponsor's protocol ID
- 20120065
- Status last verified
- Nov 2023
- First submitted
- 5 Jun 2012
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study in Preterm Infants With and Without Intracranial Hemorrhage: Longitudinal Assessment of Cerebral Oxygenation, Perfusion and Function
- ClinicalTrials.gov ID
- NCT01620203
- Acronym / sponsor ID
- 20120065
- Keywords
- Premature infants, Intracranial hemorrhage, Intraventricular hemorrhage, Cerebral oxygenation, Brain function, Cerebral perfusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Nelson ClaureUniversity, hospital or other
- Study start
- Jun 2012 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 15 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | Other: No intervention/treatment is givenMatched group of control infants without diagnosis of intracranial hemorrhage |
| Intracranial Hemorrhage | – | Other: No intervention/treatment is givenGroup of preterm infant with diagnosis of intracranial hemorrhage. |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Preterm infants admitted to the newborn intensive care unit at Holtz Children's Hospital of the Jackson Memorial Hospital/University of Miami Medical Center.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Major congenital malformations
- Birth asphyxia
- Not expected to survive
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention/treatment is given | Other | Control, Intracranial Hemorrhage |
Primary outcome
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.
1 secondary outcome
Change in cerebral perfusion and function
Time frame: post natal weeks 4 and 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nelson Claure, M.Sc.,Ph.D. principal investigator
University of Miami
Eduardo Bancalari, M.D. principal investigator
University of Miami
Deepak Jain, M.D. principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Hemorrhage and Intraventricular Hemorrhage, run by Nelson Claure at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cerebral oxygenation (time frame: postnatal weeks 4 and 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.