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

March 1, 2012
October 21, 2014
March 2012
April 2015   (final data collection date for primary outcome measure)
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.
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.
Complete list of historical versions of study NCT01549444 on ClinicalTrials.gov Archive Site
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.
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.
Not Provided
Not Provided
 
Renin and Aldosterone Levels in the Preterm Neonate At Risk for Hypertension
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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Serum samples for Renin and Alsosterone, to be discarded when study is complete.

Non-Probability Sample

Babies born between 26 and 34 weeks gestation

  • Hypertension
  • Diabetes
  • Infants Small for Gestational Age
Other: presence of maternal risk factor for hypertension
  • Group 1
    Babies of mothers that have diabetes and/or hypertension and babies that are small for dates
    Intervention: 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
76
October 2015
April 2015   (final data collection date for primary outcome measure)

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).
Both
26 Weeks to 34 Weeks
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01549444
Renin HIT study-01
No
Ottawa Hospital Research Institute
Ottawa Hospital Research Institute
  • PSI Foundation inc
  • Australian National University
Principal Investigator: Erika Bariciak, MD The Ottawa Hospital
Ottawa Hospital Research Institute
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP