Infant, Very Low Birth WeightNCT01430728
Cerebral Tissue Oxygenation in Very Low Birthweight Infants in the First 3 Days of Life
An observational study of Infant, Very Low Birth Weight, run by University of Ulm at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Infant, Very Low Birth Weight
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2011to Jun 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Very low birthweight infants treated in our hospital
Who may be able to join
- Very low birthweight infants
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Medical Center
Ulm, Baden-Wurttemberg, 89075
Manuel B Schmid, Dr. med., +49 731 500 ext. 57218, manuel.schmid@uni-ulm.de
Manuel B Schmid, Dr. med.
About this study
Official title: Cerebral Tissue Oxygen Saturation in Preterm Neonates Below 1500g Birth Weight During the First 72 Hours
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.
Read the detailed description
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
- Infant, Very Low Birth Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Very low birthweight infants | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral tissue oxygen saturation during first 72 hours of life
Measured: during first 72 hours of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2011 (estimated)
- Study startApr 2011
- Primary completionDec 2018 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infant, Very Low Birth WeightStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ulm
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manuel Schmid, University of Ulm
- Investigators
- Manuel B Schmid, Dr. med., Principal investigator, University of Ulm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01430728
- Sponsor's protocol ID
- ULMNEONIRS04
- Status last verified
- Apr 2016
- First submitted
- 6 Sep 2011
- Last updated
- 6 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 35498781
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Tissue Oxygen Saturation in Preterm Neonates Below 1500g Birth Weight During the First 72 Hours
- ClinicalTrials.gov ID
- NCT01430728
- Acronym / sponsor ID
- ULMNEONIRS04
- Conditions
- Infant, Very Low Birth Weight
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of UlmUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 8 Sep 2011 (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.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Very low birthweight infants | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Very low birthweight infants treated in our hospital
Key inclusion criteria (1 listed)
- Very low birthweight infants
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cerebral tissue oxygen saturation during first 72 hours of life
Time frame: during first 72 hours of life
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2016.
- Derived from this study: PubMed 35498781Schwab 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.
Related trials for Infant, Very Low Birth Weight
Recruiting
Effect of Developmental Care on Very Low Birth Weight Infants
Intervention
Active, not recruiting
30% or 60% Oxygen at Birth to Improve Neurodevelopmental Outcomes in Very Low Birthweight Infants
Premature Infant, Respiratory Distress Syndrome in Premature Infant
RecruitingPhase 1
Gut Permeability and Microbiome in Preterm Infants
Prematurity Complications
Not yet recruitingObservational study
Predictors of Postnatal Growth Failure in Preterm Infants
Premature Birth, Growth Failure
Recruiting
Donor Breast Milk 2
Iron Deficiency Anemia
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.
Manuel B Schmid, Dr. med. principal investigator
University of Ulm
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 Infant, Very Low Birth Weight, run by University of Ulm at 1 site in Germany.
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 1 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 6 Apr 2016. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Manuel B Schmid, Dr. med. (+49 731 500 ext. 57218, manuel.schmid@uniklinik-ulm.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebral tissue oxygen saturation during first 72 hours of life (time frame: during first 72 hours of life). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01430728, which also lists 1 linked publication.
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 6 Apr 2016.