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Ultrasound Imaging of Subarachnoidal Space in Newborn Infants
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Ultrasound Newborn Infant | Other: Ultrasound imaging | Not Applicable |
Based on the available literature the success rate of neonatal lumbar puncture (LP) is quite low (some articles reporting as low as 50% (unsuccessful LPs including dry taps and traumatic taps)).
Firstly, the investigators would like to set a normal range of CSF:spine ratio (representing the amount of CSF at the expected level of LP) based on the measurements in neonates of different gestational age and postnatal age with assessing ventricular index (VI) on cranial US.
In the next phase of the study the investigators plan to assess the subarachnoidal space/amount of CSF of those neonates whom need LP performed. The investigators hypothise to be able to create an ultrasound measurement index/number that would be able to predict unsuccessful LPs.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 2000 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Diagnostic |
| Official Title: | Ultrasound Imaging of the Subarachnoidal Space at the Lumbar Region in Preterm and Term Newborn Infants |
| Actual Study Start Date : | May 1, 2019 |
| Estimated Primary Completion Date : | September 30, 2020 |
| Estimated Study Completion Date : | January 1, 2021 |
- Normal lumbal CSF index in neonates [ Time Frame: From Day 1 to Day 7 ]Normal range (amount/ratio) of CSF in neonates, influencing the following factors: gestational age, postnatal age, fluid intake, type of delivery.
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 27, 2019 | ||||
| First Posted Date ICMJE | July 1, 2019 | ||||
| Last Update Posted Date | July 1, 2019 | ||||
| Actual Study Start Date ICMJE | May 1, 2019 | ||||
| Estimated Primary Completion Date | September 30, 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Normal lumbal CSF index in neonates [ Time Frame: From Day 1 to Day 7 ] Normal range (amount/ratio) of CSF in neonates, influencing the following factors: gestational age, postnatal age, fluid intake, type of delivery.
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Ultrasound Imaging of Subarachnoidal Space in Newborn Infants | ||||
| Official Title ICMJE | Ultrasound Imaging of the Subarachnoidal Space at the Lumbar Region in Preterm and Term Newborn Infants | ||||
| Brief Summary | Based on the ultrasound measurement of CSF/spinal cord ratio in neonates the investigators plan to define a normal range of CSF volume for 0-7 day old newborns. The investigators hypothise to be able to create an ultrasound measurement index/number to predict unsuccessful neonatalal LPs. | ||||
| Detailed Description |
Based on the available literature the success rate of neonatal lumbar puncture (LP) is quite low (some articles reporting as low as 50% (unsuccessful LPs including dry taps and traumatic taps)). Firstly, the investigators would like to set a normal range of CSF:spine ratio (representing the amount of CSF at the expected level of LP) based on the measurements in neonates of different gestational age and postnatal age with assessing ventricular index (VI) on cranial US. In the next phase of the study the investigators plan to assess the subarachnoidal space/amount of CSF of those neonates whom need LP performed. The investigators hypothise to be able to create an ultrasound measurement index/number that would be able to predict unsuccessful LPs. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Diagnostic |
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| Condition ICMJE |
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| Intervention ICMJE | Other: Ultrasound imaging
Ultrasound imaging of the lumbar spine/subarachnoidal space
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| Study Arms ICMJE | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Unknown status | ||||
| Estimated Enrollment ICMJE |
2000 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | January 1, 2021 | ||||
| Estimated Primary Completion Date | September 30, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria: All neonates born at the Obstretrics and Gynecology Department, University of Szeged and all treated neonates at the Neonatal Unit, Pediatric Department, University of Szeged Exclusion Criteria: Hemidynamical instability, Strict minimal handling (eg Pulmonary Hypertension, MAS etc), Total Body Coooling for HIE (Hypoxic Ischemic Encephalopathy) |
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| Sex/Gender ICMJE |
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| Ages ICMJE | up to 7 Days (Child) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | Hungary | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT04004130 | ||||
| Other Study ID Numbers ICMJE | 207/2018 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||
| Responsible Party | Judit Mari, Szeged University | ||||
| Study Sponsor ICMJE | Szeged University | ||||
| Collaborators ICMJE | Affidea Magyarország | ||||
| Investigators ICMJE | Not Provided | ||||
| PRS Account | Szeged University | ||||
| Verification Date | June 2019 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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