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.

Study Overview

• Status: Completed
• Conditions: Hypertension; Diabetes; Infants Small for Gestational Age
• Intervention / Treatment: Other: presence of maternal risk factor for hypertension

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 Type: Observational
• Enrollment (Actual): 76

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1H 8L1
      • Children's Hospital of Eastern Ontario
    • Ottawa, Ontario, Canada, K1H 8L6
      • The Ottawa Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 months to 7 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Babies born between 26 and 34 weeks gestation

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	at birth and at 2-3 weeks of age

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	in the first month of life, then at 4 and10 months of age

Collaborators and Investigators

• Sponsor: Ottawa Hospital Research Institute
• Collaborators: The Physicians' Services Incorporated Foundation; Australian National University
• Investigators: Principal Investigator: Erika Bariciak, MD, The Ottawa Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: March 1, 2012
• First Submitted That Met QC Criteria: March 8, 2012
• First Posted (Estimate): March 9, 2012

Study Record Updates

• Last Update Posted (Estimate): October 22, 2015
• Last Update Submitted That Met QC Criteria: October 21, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: aldosterone; neonate; renin
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: Renin HIT study-01