Cerebral Tissue Oxygenation in Very Low Birthweight Infants in the First 3 Days of Life

NCT ID: NCT01430728

Last Updated: 2016-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-04-30

Study Completion Date

2019-06-30

Brief Summary

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The purpose of this study is to examine the range of cerebral tissue oxygen saturation in healthy and sick very low birthweight infants during the first 72 hours of life.

Detailed Description

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In this observational trial we want to examine cerebral tissue oxygen saturation, total hemoglobin, fractional tissue oxygen extraction and HbD as measured by near infrared spectroscopy during the first 72h of life in very low birthweight infants.

Differences between relatively healthy and sick preterm infants will be explored. A focus is to find differences between those infants who develop germinal matrix hemorrhage and those who are at risk only but do not develop hemorrhage.

Conditions

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Infant, Very Low Birth Weight

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Very low birthweight infants

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Very low birthweight infants
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Ulm

OTHER

Sponsor Role lead

Responsible Party

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Manuel Schmid

Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Manuel B Schmid, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

University of Ulm

Locations

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University Medical Center

Ulm, Baden-Wurttemberg, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Manuel B Schmid, Dr. med.

Role: CONTACT

+49 731 500 ext. 57218

Facility Contacts

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Manuel B Schmid, Dr. med.

Role: primary

+49 731 500 ext. 57218

References

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Schwab AL, Mayer B, Bassler D, Hummler HD, Fuchs HW, Bryant MB. Cerebral Oxygenation in Preterm Infants Developing Cerebral Lesions. Front Pediatr. 2022 Apr 12;10:809248. doi: 10.3389/fped.2022.809248. eCollection 2022.

Reference Type DERIVED
PMID: 35498781 (View on PubMed)

Other Identifiers

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ULMNEONIRS04

Identifier Type: -

Identifier Source: org_study_id

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