Infant, PrematureNCT02848755
Brain Volumes of Very Low Birth Weight Infants Measured by Cranial Ultrasonography
An observational study of Infant, Premature, run by Zekai Tahir Burak Women's Health Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
Neonatal cranial ultrasound (US) remains the method of choice to detect brain injury in high risk preterm infants on neonatal intensive care units (NICU). It is a non-invasive, inexpensive bedside tool and examinations can be repeated as often as necessary without major disturbance of vulnerable infants. Read more about this study
- Who is it for?
- Ages 1 day to 40 weeks
- Conditions the study is for
- Infant, Premature
- What is being tested?
- Cranial ultrasonography
- Type of treatment
- Medical device
- How many people
- 341 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2017to 9 Jun 2018
- 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 40 weeks
- All sexes
- No healthy volunteers
- Child
Study population: All NICU preterm infants under 1500 gr
Who may be able to join
- both gender
- <1500 gr <32 week-
- 1-28 days neonates
Who cannot join
- Anomalies and no viability
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neonatal Cranial Ultrasonography for Measuring Brain Volumes of Very Low Birth Weight Infants
Neonatal cranial ultrasound (US) remains the method of choice to detect brain injury in high risk preterm infants on neonatal intensive care units (NICU). It is a non-invasive, inexpensive bedside tool and examinations can be repeated as often as necessary without major disturbance of vulnerable infants. The anterior and posterior fontanelles from excellent acoustic windows to examine the deep midline and periventricular regions of the brain.Some data demonstrated that cerebral palsy can be accurately predicted with US. However, cranial US is not very suitable for investigating cortical regions or structures in the posterior fossa. There is limited data for very preterm infants.The investigators aimed to measure ventricular index, cranial height, biparietal diameter and calculate brain volume in a huge number of infants.
- Conditions
- Infant, Premature
- Being tested
- Cranial ultrasonography
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cranial ultrasonographyDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
measurements of ventricular indexes of preterm infants
measuring distance with 2D USG
Measured: 12 months
measurements of brain volumes of preterm infants
subtracting the ventricular volumes from the total brain volume measured with 2D
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2016 (estimated)
- Study start1 Jan 2017
- Primary completion9 May 2018
- Study completion9 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Infant, PrematureStudies 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
- 341 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zekai Tahir Burak Women's Health Research and Education Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Netherlands: Ministry of Health, Welfare and Sports
- Responsible party
- Principal investigator, Gulsum Kadioğlu Simsek, Zekai Tahir Burak Women's Health Research and Education Hospital
- Investigators
- Fuat Emre Canpolat, Principal investigator, Zekai Tahir Burak Hospital NICU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02848755
- Sponsor's protocol ID
- 2016-Cr-USG-1
- Status last verified
- Jun 2018
- First submitted
- 27 May 2016
- Last updated
- 15 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
Rademaker KJ, Uiterwaal CS, Beek FJ, van Haastert IC, Lieftink AF, Groenendaal F, Grobbee DE, de Vries LS. Neonatal cranial ultrasound versus MRI and neurodevelopmental outcome at school age in children born preterm. Arch Dis Child Fetal Neonatal Ed. 2005 Nov;90(6):F489-93. doi: 10.1136/adc.2005.073908. Epub 2005 Jun 14.
PubMed 15956095Isik S, Buyuktiryaki M, Simsek GK, Kutman HGK, Canpolat FE. Relationship between biparietal diameter/ventricular ratio and neurodevelopmental outcomes in non-handicapped very preterm infants. Childs Nerv Syst. 2021 Apr;37(4):1121-1126. doi: 10.1007/s00381-020-04960-5. Epub 2020 Nov 11.
PubMed 33175184Simsek GK, Canpolat FE, Buyuktiryaki M, Okman E, Keser M, Ustunyurt Z, Kutman HGK. Developmental outcomes of very low birthweight infants with non-hemorrhagic ventricular dilatations and the relationships thereof with absolute brain volumes measured via two-dimensional ultrasonography. Childs Nerv Syst. 2020 Jun;36(6):1231-1237. doi: 10.1007/s00381-019-04464-x. Epub 2019 Dec 18.
PubMed 31853896
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neonatal Cranial Ultrasonography for Measuring Brain Volumes of Very Low Birth Weight Infants
- ClinicalTrials.gov ID
- NCT02848755
- Acronym / sponsor ID
- 2016-Cr-USG-1
- Conditions
- Infant, Premature
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 341 participants (actual)
- Lead sponsor
- Zekai Tahir Burak Women's Health Research and Education HospitalUniversity, hospital or other
- Collaborators
- Netherlands: Ministry of Health, Welfare and Sports
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 9 May 2018 (actual)
- Study completion
- 9 Jun 2018 (actual)
- First posted
- 28 Jul 2016 (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.
Neonatal cranial ultrasound (US) remains the method of choice to detect brain injury in high risk preterm infants on neonatal intensive care units (NICU). It is a non-invasive, inexpensive bedside tool and examinations can be repeated as often as necessary without major disturbance of vulnerable infants. The anterior and posterior fontanelles from excellent acoustic windows to examine the deep midline and periventricular regions of the brain.Some data demonstrated that cerebral palsy can be accurately predicted with US. However, cranial US is not very suitable for investigating cortical regions or structures in the posterior fossa. There is limited data for very preterm infants.The investigators aimed to measure ventricular index, cranial height, biparietal diameter and calculate brain volume in a huge number of infants.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 40 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All NICU preterm infants under 1500 gr
Key inclusion criteria (3 listed)
- both gender
- <1500 gr <32 week-
- 1-28 days neonates
Key exclusion criteria (1 listed)
- Anomalies and no viability
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 |
|---|---|---|
| Cranial ultrasonography | Device | – |
Primary outcome
measurements of ventricular indexes of preterm infants
Time frame: 12 months
measuring distance with 2D USG
measurements of brain volumes of preterm infants
Time frame: 12 months
subtracting the ventricular volumes from the total brain volume measured with 2D
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 15 Jun 2018.
- Background: PubMed 15956095Rademaker KJ, Uiterwaal CS, Beek FJ, van Haastert IC, Lieftink AF, Groenendaal F, Grobbee DE, de Vries LS. Neonatal cranial ultrasound versus MRI and neurodevelopmental outcome at school age in children born preterm. Arch Dis Child Fetal Neonatal Ed. 2005 Nov;90(6):F489-93. doi: 10.1136/adc.2005.073908. Epub 2005 Jun 14.
- Derived from this study: PubMed 33175184Isik S, Buyuktiryaki M, Simsek GK, Kutman HGK, Canpolat FE. Relationship between biparietal diameter/ventricular ratio and neurodevelopmental outcomes in non-handicapped very preterm infants. Childs Nerv Syst. 2021 Apr;37(4):1121-1126. doi: 10.1007/s00381-020-04960-5. Epub 2020 Nov 11.
- Derived from this study: PubMed 31853896Simsek GK, Canpolat FE, Buyuktiryaki M, Okman E, Keser M, Ustunyurt Z, Kutman HGK. Developmental outcomes of very low birthweight infants with non-hemorrhagic ventricular dilatations and the relationships thereof with absolute brain volumes measured via two-dimensional ultrasonography. Childs Nerv Syst. 2020 Jun;36(6):1231-1237. doi: 10.1007/s00381-019-04464-x. Epub 2019 Dec 18.
- Individual participant dataSharing planned: Yes
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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.
Fuat Emre Canpolat principal investigator
Zekai Tahir Burak Hospital NICU
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, Premature, run by Zekai Tahir Burak Women's Health Research and Education Hospital at 1 site in Turkey (Türkiye).
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 1 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 15 Jun 2018. 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 Turkey (Türkiye). 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?
measurements of ventricular indexes of preterm infants (time frame: 12 months). The study lists 2 primary outcomes in all. 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 NCT02848755, which also lists 3 linked publications.
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 15 Jun 2018.