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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT03104296 |
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Date of registration:
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03/04/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Correlation Between Cerebral Oxygenation and Neurodevelopment in VLBW Preterm Infants.
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Scientific title:
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Correlation Between Neonatal Cerebral Oxygenation and Later Psychomotor Outcome in Very-low-birth-weight Preterm Infants. |
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Date of first enrolment:
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November 1, 2013 |
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Target sample size:
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63 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03104296 |
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Study type:
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Observational |
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Study design:
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Phase:
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N/A
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Countries of recruitment
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Italy
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- gestational age <32 weeks
- birth weight <1500 g.
Exclusion Criteria:
- congenital abnormalities
- hypoxic-ischemic encephalopathy
- intraventricular haemorrhage grade 3-4
- post-haemorrhagic ventricular dilatation
- periventricular leukomalacia and/or porencephalic cysts
- general anaesthesia
Age minimum:
N/A
Age maximum:
2 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Psychomotor Impairment
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Intervention(s)
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Diagnostic Test: Griffiths Mental Development Scales
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Primary Outcome(s)
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Psychomotor outcome
[Time Frame: 24 months]
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Secondary ID(s)
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NIRS-SO
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PRET_01_13
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SO-2016-GQ
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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