Renin and Aldosterone Levels in the Preterm Neonate At Risk for Hypertension
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Purpose
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 |
|---|
|
Hypertension Diabetes Infants Small for Gestational Age |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Renin and Aldosterone Levels in the Preterm Neonate At Risk for Hypertension (RENAL HIT Study) |
- 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.
- 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.
Biospecimen Retention: Samples Without DNA
Serum samples for Renin and Alsosterone, to be discarded when study is complete.
| Estimated Enrollment: | 80 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | September 2013 |
| Groups/Cohorts |
|---|
|
Group 1
Babies of mothers that have diabetes and/or hypertension and babies that are small for dates
|
|
Group 2
Babies born to mothers without diabetes and/or hypertension and babies that are correct size for gestational age
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 26 Weeks to 34 Weeks |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Babies between 26 and 34 weeks gestation
Inclusion Criteria:
- Infants < 6 hours of age who require NICU admission
- Infants 26+0 to 34+0 weeks gestation.
Exclusion Criteria:
Immediate Exclusion from Enrollment
- Maternal treatment with drugs known to be teratogenic and cause nephrotoxicity in the fetus (i.e. ACE-Inhibitor).
- Infants with known congenital anomalies and/or renal anomalies.
- Infants with known chromosomal anomalies.
- Infants with severe asphyxia defined as cord pH < 7.0, 5 min Apgar < 3, and urine positive for blood.
- 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).
- Infants who will not receive follow-up care in Ottawa upon discharge from the NICU (ie: live out of town).
Contacts and Locations| Contact: Erika Bariciak, MD | 613-737-7600 ext 2954 | bariciak@cheo.on.ca |
| Contact: Brigitte Lemyre, MD | 613-737-8899 ext 71882 | blemyre@ottawahospital.on.ca |
| Canada, Ontario | |
| The Ottawa Hospital | Not yet recruiting |
| Ottawa, Ontario, Canada, K1H 8L6 | |
| Contact: Erika Bariciak, MD 613-737-7600 ext 2954 bariciak@cheo.on.ca | |
| Principal Investigator: Erika Bariciak, MD | |
| Principal Investigator: | Erika Bariciak, MD | The Ottawa Hospital |
More Information
No publications provided
| Responsible Party: | Ottawa Hospital Research Institute |
| ClinicalTrials.gov Identifier: | NCT01549444 History of Changes |
| Obsolete Identifiers: | NCT01545895 |
| Other Study ID Numbers: | Renin HIT study-01 |
| Study First Received: | March 1, 2012 |
| Last Updated: | March 8, 2012 |
| Health Authority: | Canada: Ethics Review Committee |
Additional relevant MeSH terms:
|
Hypertension Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 23, 2013