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

Completed

• Conditions: Infants Small for Gestational Age; Hypertension; Diabetes
• Interventions: Other: presence of maternal risk factor for hypertension

• Registration Number: NCT01549444
• Lead Sponsor: Ottawa Hospital Research Institute

Brief 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. 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 Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-03-01
• Study First Submitted QC: 2012-03-08
• Study First Posted: 2012-03-09
• Primary Completion: 2015-04
• Status Verified: 2015-10
• Study Completion: 2015-10
• Last Update Submitted: 2015-10-21
• Last Update Posted: 2015-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	presence of maternal risk factor for hypertension	Babies of mothers that have diabetes and/or hypertension and babies that are small for dates

Primary Outcome Measures

Name	Time	Method
Renin and Aldosterone levels corelated to BP measurements	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.

Secondary Outcome Measures

Name	Time	Method
Blood pressure measurements	in the first month of life, then at 4 and10 months of age	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.

Trial Locations

Locations (2)

Children's Hospital of Eastern Ontario; 🇨🇦 Ottawa, Ontario, Canada

The Ottawa Hospital; 🇨🇦 Ottawa, Ontario, Canada