Renin and Aldosterone Levels in the Preterm Neonate At Risk for Hypertension
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|ClinicalTrials.gov Identifier: NCT01549444|
Recruitment Status : Completed
First Posted : March 9, 2012
Last Update Posted : October 22, 2015
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.
|Condition or disease||Intervention/treatment|
|Hypertension Diabetes Infants Small for Gestational Age||Other: presence of maternal risk factor for hypertension|
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 :||Observational|
|Actual Enrollment :||76 participants|
|Official Title:||Renin and Aldosterone Levels in the Preterm Neonate At Risk for Hypertension (RENAL HIT Study)|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||April 2015|
|Actual Study Completion Date :||October 2015|
Babies of mothers that have diabetes and/or hypertension and babies that are small for dates
|Other: presence of maternal risk factor for hypertension|
Babies born to mothers without diabetes and/or hypertension and babies that are correct size for gestational age
- Renin and Aldosterone levels corelated to BP measurements [ Time Frame: at birth and at 2-3 weeks of age ]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.
- Blood pressure measurements [ Time Frame: in the first month of life, then at 4 and10 months of age ]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.
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01549444
|Children's Hospital of Eastern Ontario|
|Ottawa, Ontario, Canada, K1H 8L1|
|The Ottawa Hospital|
|Ottawa, Ontario, Canada, K1H 8L6|
|Principal Investigator:||Erika Bariciak, MD||The Ottawa Hospital|