NCT01430728

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 8, 2011

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

April 6, 2016

Status Verified

April 1, 2016

Enrollment Period

7.7 years

First QC Date

September 6, 2011

Last Update Submit

April 5, 2016

Conditions

Infant, Very Low Birth Weight

Outcome Measures

Primary Outcomes (1)

  • Cerebral tissue oxygen saturation during first 72 hours of life

    during first 72 hours of life

Study Arms (1)

Very low birthweight infants

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Very low birthweight infants treated in our hospital

You may qualify if:

  • Very low birthweight infants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center

Ulm, Baden-Wurttemberg, 89075, Germany

RECRUITING

Related Publications (1)

  • 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.

    PMID: 35498781DERIVED

Study Officials

  • Manuel B Schmid, Dr. med.

    University of Ulm

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Manuel B Schmid, Dr. med.

CONTACT

+49 731 500manuel.schmid@uniklinik-ulm.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. med.

Study Record Dates

First Submitted

September 6, 2011

First Posted

September 8, 2011

Study Start

April 1, 2011

Primary Completion

December 1, 2018

Study Completion

June 1, 2019

Last Updated

April 6, 2016

Record last verified: 2016-04

Locations

DE(1)