Renin and Aldosterone Levels in the Preterm Neonate At Risk for Hypertension

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
PSI Foundation inc
Australian National University
Information provided by (Responsible Party):
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT01549444
First received: March 1, 2012
Last updated: October 21, 2014
Last verified: October 2014
  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 Intervention
Hypertension
Diabetes
Infants Small for Gestational Age
Other: presence of maternal risk factor for hypertension

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)

Resource links provided by NLM:


Further study details as provided by Ottawa Hospital Research Institute:

Primary Outcome Measures:
  • Renin and Aldosterone levels corelated to BP measurements [ Time Frame: at birth and at 2-3 weeks of age ] [ 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.


Secondary Outcome Measures:
  • Blood pressure measurements [ Time Frame: in the first month of life, then at 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.


Enrollment: 76
Study Start Date: March 2012
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1
Babies of mothers that have diabetes and/or hypertension and babies that are small for dates
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

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
Study Population

Babies born between 26 and 34 weeks gestation

Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01549444

Locations
Canada, Ontario
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada, K1H 8L1
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L6
Sponsors and Collaborators
Ottawa Hospital Research Institute
PSI Foundation inc
Australian National University
Investigators
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: October 21, 2014
Health Authority: Canada: Institutional Review Board

Keywords provided by Ottawa Hospital Research Institute:
renin
aldosterone
neonate

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014