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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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21 December 2021 |
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Main ID: |
NCT03145142 |
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Date of registration:
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04/05/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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PREMOD2 NIRS Substudy - A Randomized Trial of Cerebral Oxygen Saturation in Infants Randomized to Umbilical Cord Milking or Delayed Cord Clamping
PREMOD2 |
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Scientific title:
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PREMOD2 NIRS Substudy - A Randomized Trial of Cerebral Oxygen Saturation in Infants Randomized to Umbilical Cord Milking or Delayed Cord Clamping |
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Date of first enrolment:
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June 6, 2017 |
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Target sample size:
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121 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03145142 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Canada
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Germany
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Ireland
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United States
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Contacts
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Name:
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Anup C Katheria, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sharp Mary Birch Hospital for Women & Newborns |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 23 weeks 0 days to 27 weeks 6 days.
- Enrolled in PREMOD2 trial.
Exclusion Criteria:
- NIRS Device not available
- Research Personnel not available
Age minimum:
23 Weeks
Age maximum:
28 Weeks
Gender:
All
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Health Condition(s) or Problem(s) studied
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Premature Birth
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Hypoxia, Brain
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Intervention(s)
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Procedure: Delayed Cord Clamping
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Procedure: Umbilical cord milking
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Primary Outcome(s)
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StO2 - 10M
[Time Frame: 1st 10 minutes of life]
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Secondary Outcome(s)
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Blood Pressure NICU
[Time Frame: 2st 24 hours of life]
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StO2 - 24H
[Time Frame: 1st 24 hours of life]
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HR - 10M
[Time Frame: 1st 10 minutes of life]
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HR 24H
[Time Frame: 1st 24 hours of life]
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Secondary ID(s)
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1R01HD088646-01A1
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PREMOD2 - NIRS Sub-study
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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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