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Main
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Note: This record shows only the 20 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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17 October 2012 |
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Main ID: |
NCT01549444 |
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Date of registration:
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01/03/2012 |
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Primary sponsor: |
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Public title:
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Renin and Aldosterone Levels in the Preterm Neonate At Risk for Hypertension
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Scientific title:
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Renin and Aldosterone Levels in the Preterm Neonate At Risk for Hypertension (RENAL HIT Study) |
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Date of first enrolment:
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March 2012 |
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Target sample size:
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80 |
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Recruitment status: |
Not yet recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01549444 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Countries of recruitment
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Canada
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Contacts
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Name:
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Erika Bariciak, MD |
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Address:
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Telephone:
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613-737-7600 |
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Email:
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bariciak@cheo.on.ca |
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Affiliation:
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Name:
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Erika Bariciak, MD |
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Address:
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Telephone:
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613-737-7600 |
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Email:
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bariciak@cheo.on.ca |
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Affiliation:
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Name:
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Erika Bariciak, 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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The Ottawa Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Infants < 6 hours of age who require NICU admission
2. Infants 26+0 to 34+0 weeks gestation.
Exclusion Criteria:
- Immediate Exclusion from Enrollment
1. Maternal treatment with drugs known to be teratogenic and cause nephrotoxicity
in the fetus (i.e. ACE-Inhibitor).
2. Infants with known congenital anomalies and/or renal anomalies.
3. Infants with known chromosomal anomalies.
4. Infants with severe asphyxia defined as cord pH < 7.0, 5 min Apgar < 3, and
urine positive for blood.
5. Infants with a known or suspected blood loss at birth (ie: uterine rupture,
placental abruption, bleeding placenta previa, or post-natal blood loss in the
delivery room).
6. Infants who will not receive follow-up care in Ottawa upon discharge from the
NICU (ie: live out of town).
Age minimum:
26 Weeks
Age maximum:
34 Weeks
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Diabetes
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Hypertension
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Infants Small for Gestational Age
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Primary Outcome(s)
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Renin and Aldosterone levels corelated to BP measurements
[Time Frame: by 2-3 weeks of age for bloodwork]
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Secondary Outcome(s)
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Blood pressure measurements
[Time Frame: 4 and10 months of age]
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Secondary ID(s)
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Renin HIT study-01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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