Renin and Aldosterone Levels in the Preterm Neonate At Risk for Hypertension
|First Received Date ICMJE||March 1, 2012|
|Last Updated Date||March 8, 2012|
|Start Date ICMJE||March 2012|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Renin and Aldosterone levels corelated to BP measurements [ Time Frame: by 2-3 weeks of age for bloodwork ] [ Designated as safety issue: No ]
We hypothesize that infants with higher levels of RE and ALDO at birth and in the early neonatal period will have a higher BP during the first year of life.
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT01549444 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||Blood pressure measurements [ Time Frame: 4 and10 months of age ] [ Designated as safety issue: No ]
We hypothesize that premature infants of mothers with hypertension (HT) and/or diabetes, or who are significantly growth restricted will have a higher blood pressure (BP) in the first year of life.
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Renin and Aldosterone Levels in the Preterm Neonate At Risk for Hypertension|
|Official Title ICMJE||Renin and Aldosterone Levels in the Preterm Neonate At Risk for Hypertension (RENAL HIT Study)|
The purpose of this study is to find out if mothers with high blood pressure (Hypertension) and/or diabetes have babies with high levels of different substances (that help to regulate blood pressure, called Renin and Aldosterone) in their blood. The investigators are also trying to determine if these babies have higher blood pressure than those babies born to mothers without high blood pressure or diabetes, during the first year of life.
The investigators will measure your baby's blood pressure once a day for the first 4 days, at 1 week of age, and then once per week until your baby is discharged. The investigators will also measure the blood pressure after discharge at 4 and 10 months of age, either on the day of your baby's follow-up appointment in the Neonatal Follow-up Clinic or at a visit to our Outpatient Nephrology Clinic, both at CHEO.
We will compare two groups of babies born between 26+0 and 34+0 weeks gestation.Group 1 is the babies born to mothers with diabetes and/or high blood pressure, and babies that are small for dates. Group 2 are babies that are 26 to 34 weeks of age, that are born to mothers without these problems.
In the study we will measure the baby's blood pressure once a day for the first 4 days, at 1 week of age, and then once per week until the baby is discharged. We will also measure the blood pressure after discharge at 4 and 10 months of age, either on the day of your baby's follow-up appointment in the Neonatal Follow-up Clinic or at a visit to our Outpatient Nephrology Clinic, both at CHEO.
As blood tests will be done. A small amount of extra blood, 0.75ml - 1.5 ml (about 1/6 -1/3 of a teaspoon, or approximately 1 ml) will be collected for measurement of the blood substances we are studying will be collected when the baby has their regular non-study blood work.
This will be done within six hours of birth and then again at 2-3 weeks of life.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Observational Model: Cohort
Time Perspective: Prospective
|Target Follow-Up Duration||Not Provided|
|Biospecimen||Retention: Samples Without DNA
Serum samples for Renin and Alsosterone, to be discarded when study is complete.
|Sampling Method||Non-Probability Sample|
Babies between 26 and 34 weeks gestation
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Not yet recruiting|
|Estimated Enrollment ICMJE||80|
|Estimated Completion Date||September 2013|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||26 Weeks to 34 Weeks|
|Accepts Healthy Volunteers||No|
|Location Countries ICMJE||Canada|
|NCT Number ICMJE||NCT01549444|
|Other Study ID Numbers ICMJE||Renin HIT study-01|
|Has Data Monitoring Committee||No|
|Responsible Party||Ottawa Hospital Research Institute|
|Study Sponsor ICMJE||Ottawa Hospital Research Institute|
|Collaborators ICMJE||The Physicians' Services Incorporated Foundation|
|Information Provided By||Ottawa Hospital Research Institute|
|Verification Date||March 2012|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP