Central Nervous System Vulnerabilities in Preterm InfantsNCT04190017
Comparison of Brain Volumes Measured by 2D USG and MRI
An observational study of Central Nervous System Vulnerabilities in Preterm Infants, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
Cranial USG is simple and easy method to assess preterm infant brain. Some studies showed that brain volumes of preterm infants could be calculated by measurement of 2D distances. Our aim in this study was to compare brain volume obtained by USG and MRI. Read more about this study
- Who is it for?
- Ages 1 day to 3 months
- Conditions the study is for
- Central Nervous System Vulnerabilities in Preterm Infants
- What is being tested?
- Cranial MRI
- How many people
- 25 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2019to 30 Mar 2022
- 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 3 months
- All sexes
- No healthy volunteers
- Child
Study population: Preterm infants under 32 weeks of GA and 800-1200 gram BW all admitted to Ankara Şehir Hospital MH5 NICU
Who may be able to join
- All preterm infants under 32 weeks of gestational age and birth weight between 800-1200 grams
- Born in our hospital
- Alive during discharge
Who cannot join
- congenital anomalies
- cranial bleeding
- early death
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara City Hospital
Ankara
Mustafa Şenol Akın, MD, +905558760585, mustafasenolakin@gmail.com
About this study
Official title: Comparison of Brain Volumes of Preterm Infants Measured by Two Dimensional Ultrasonography and Cranial Magnetic Resonance Imaging
Cranial USG is simple and easy method to assess preterm infant brain. Some studies showed that brain volumes of preterm infants could be calculated by measurement of 2D distances. Our aim in this study was to compare brain volume obtained by USG and MRI.
Read the detailed description
All preterm infants less than 32 weeks of gestational age undergo cranial USG examination routinely at least, in the first week of life, at the end of first month and corrected age 36 weeks and 40 weeks. We will performa all USG mesurements with measureing intracranial hegiht, anteroposterior diameter, biparietal diamater, ventriccular height, thalamo-occipital distance and ventricular index. We will calculate the brain volume as a spheric geometric shape than we will calculate two ventricles as conical shapes. Absolute brain volume will be calculating by substracting two ventricles from total brain volume. At 40 weeks of age we will perform a cranial MRI to show exact brain volume and we will ccompare two different methods.
- Being tested
- Cranial MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cranial MRIOther
Cranial MRI
What is being measured
The primary outcome is the main question the study is designed to answer.
Results of two different brain volumes
Patients in cohort will have both USG and cranial MRI
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2019
- Study start1 Nov 2019
- Primary completion30 Dec 2021 (estimated)
- Study completion30 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Central Nervous System Vulnerabilities in Preterm InfantsStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- 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
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fuat Emre Canpolat, Ankara City Hospital Bilkent
- Investigators
- Mustafa Şenol Akın, MD, Study chair, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04190017
- Sponsor's protocol ID
- 2019512-1
- Status last verified
- Jan 2021
- First submitted
- 5 Dec 2019
- Last updated
- 13 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Benavente-Fernandez I, Lubian-Gutierrez M, Jimenez-Gomez G, Lechuga-Sancho AM, Lubian-Lopez SP; Neonatal Neurology Foundation (Fundacion Nene). Ultrasound lineal measurements predict ventricular volume in posthaemorrhagic ventricular dilatation in preterm infants. Acta Paediatr. 2017 Feb;106(2):211-217. doi: 10.1111/apa.13645. Epub 2016 Nov 21.
PubMed 27783429Cheong JL, Thompson DK, Spittle AJ, Potter CR, Walsh JM, Burnett AC, Lee KJ, Chen J, Beare R, Matthews LG, Hunt RW, Anderson PJ, Doyle LW. Brain Volumes at Term-Equivalent Age Are Associated with 2-Year Neurodevelopment in Moderate and Late Preterm Children. J Pediatr. 2016 Jul;174:91-97.e1. doi: 10.1016/j.jpeds.2016.04.002. Epub 2016 May 9.
PubMed 27174146
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Brain Volumes of Preterm Infants Measured by Two Dimensional Ultrasonography and Cranial Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT04190017
- Acronym / sponsor ID
- 2019512-1
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 30 Mar 2022 (estimated)
- First posted
- 9 Dec 2019 (actual)
- 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.
Cranial USG is simple and easy method to assess preterm infant brain. Some studies showed that brain volumes of preterm infants could be calculated by measurement of 2D distances. Our aim in this study was to compare brain volume obtained by USG and MRI.
Detailed description
All preterm infants less than 32 weeks of gestational age undergo cranial USG examination routinely at least, in the first week of life, at the end of first month and corrected age 36 weeks and 40 weeks. We will performa all USG mesurements with measureing intracranial hegiht, anteroposterior diameter, biparietal diamater, ventriccular height, thalamo-occipital distance and ventricular index. We will calculate the brain volume as a spheric geometric shape than we will calculate two ventricles as conical shapes. Absolute brain volume will be calculating by substracting two ventricles from total brain volume. At 40 weeks of age we will perform a cranial MRI to show exact brain volume and we will ccompare two different methods.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Preterm infants under 32 weeks of GA and 800-1200 gram BW all admitted to Ankara Şehir Hospital MH5 NICU
Key inclusion criteria (3 listed)
- All preterm infants under 32 weeks of gestational age and birth weight between 800-1200 grams
- Born in our hospital
- Alive during discharge
Key exclusion criteria (3 listed)
- congenital anomalies
- cranial bleeding
- early death
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 MRICranial MRI | Other | – |
Primary outcome
Results of two different brain volumes
Time frame: 6 months
Patients in cohort will have both USG and cranial MRI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2021.
- Background: PubMed 27783429Benavente-Fernandez I, Lubian-Gutierrez M, Jimenez-Gomez G, Lechuga-Sancho AM, Lubian-Lopez SP; Neonatal Neurology Foundation (Fundacion Nene). Ultrasound lineal measurements predict ventricular volume in posthaemorrhagic ventricular dilatation in preterm infants. Acta Paediatr. 2017 Feb;106(2):211-217. doi: 10.1111/apa.13645. Epub 2016 Nov 21.
- Background: PubMed 27174146Cheong JL, Thompson DK, Spittle AJ, Potter CR, Walsh JM, Burnett AC, Lee KJ, Chen J, Beare R, Matthews LG, Hunt RW, Anderson PJ, Doyle LW. Brain Volumes at Term-Equivalent Age Are Associated with 2-Year Neurodevelopment in Moderate and Late Preterm Children. J Pediatr. 2016 Jul;174:91-97.e1. doi: 10.1016/j.jpeds.2016.04.002. Epub 2016 May 9.
- Individual participant dataSharing planned: No
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.
Mustafa Şenol Akın, MD study chair
Ankara City Hospital Bilkent
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 Central Nervous System Vulnerabilities in Preterm Infants, run by Ankara City Hospital Bilkent 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 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: status not confirmed, as of the sponsor's last update on 13 Jan 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact FUAT EMRE CANPOLAT, MD (05055668716, femrecan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Results of two different brain volumes (time frame: 6 months). 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 NCT04190017, which also lists 2 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 13 Jan 2021.