HypertensionNCT01549444
Renin and Aldosterone Levels in the Preterm Neonate At Risk for Hypertension
An observational study of Hypertension and Diabetes, run by Ottawa Hospital Research Institute at 2 sites in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 26 to 34 weeks
- Conditions the study is for
- Hypertension, Diabetes, Infants Small for Gestational Age
- What is being tested?
- presence of maternal risk factor for hypertension
- How many people
- 76 participants
- Where
- 2 sitesCanada
- Study dates
- Mar 2012to Oct 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 26 to 34 weeks
- All sexes
- No healthy volunteers
- Child
Study population: Babies born between 26 and 34 weeks gestation
Who may be able to join
- Infants < 6 hours of age who require NICU admission
- Infants 26+0 to 34+0 weeks gestation.
Who cannot join
- 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).
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Children's Hospital of Eastern Ontario
Ottawa, Ontario, K1H 8L1
The Ottawa Hospital
Ottawa, Ontario, K1H 8L6
About this study
Official title: 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.
Read the 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.
- Conditions
- Hypertension, Diabetes, Infants Small for Gestational Age
- Being tested
- presence of maternal risk factor for hypertension
- Keywords
- renin, aldosterone, neonate
- Medical subject headings
- Hypertension, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
presence of maternal risk factor for hypertensionOther
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Babies of mothers that have diabetes and/or hypertension and babies that are small for dates Receives: Other: presence of maternal risk factor for hypertension | |
| Group 2 | Babies born to mothers without diabetes and/or hypertension and babies that are correct size for gestational age |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renin and Aldosterone levels corelated to BP measurements
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.
Measured: at birth and at 2-3 weeks of age
Secondary outcomes (1)
Blood pressure measurements
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.
Measured: in the first month of life, then at 4 and10 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionApr 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation, Australian National University
- Responsible party
- Sponsor
- Investigators
- Erika Bariciak, MD, Principal investigator, The Ottawa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01549444
- Sponsor's protocol ID
- Renin HIT study-01
- Status last verified
- Oct 2015
- First submitted
- 1 Mar 2012
- Last updated
- 22 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renin and Aldosterone Levels in the Preterm Neonate At Risk for Hypertension (RENAL HIT Study)
- ClinicalTrials.gov ID
- NCT01549444
- Acronym / sponsor ID
- Renin HIT study-01
- Conditions
- Hypertension, Diabetes, Infants Small for Gestational Age
- Keywords
- renin, aldosterone, neonate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation, Australian National University
- Study start
- Mar 2012
- Primary completion
- Apr 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 9 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: presence of maternal risk factor for hypertensionBabies 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 |
Who may qualify
- Ages
- 26 to 34 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Babies born between 26 and 34 weeks gestation
Key inclusion criteria (2 listed)
- Infants < 6 hours of age who require NICU admission
- Infants 26+0 to 34+0 weeks gestation.
Key exclusion criteria (7 listed)
- Immediate Exclusion from Enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| presence of maternal risk factor for hypertension | Other | Group 1 |
Primary outcome
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.
1 secondary outcome
Blood pressure measurements
Time frame: in the first month of life, then at 4 and10 months of age
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erika Bariciak, MD principal investigator
The Ottawa Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension and Diabetes, run by Ottawa Hospital Research Institute at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Renin and Aldosterone levels corelated to BP measurements (time frame: at birth and at 2-3 weeks of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2015.