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

NCT01549444 | Completed

• 1 other identifier: Renin HIT study-01
• Study Type: observational
• Target: 76
• Locations: 1 country
• Sites: 2

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.

Conditions

Hypertension; Diabetes; Infants Small for Gestational Age

Keywords

renin; aldosterone; neonate

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Blood pressure measurements

  in the first month of life, then at 4 and10 months of age

Study Arms (2)

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

Interventions

presence of maternal risk factor for hypertension OTHER

Group 1

Eligibility Criteria

• Age: 26 Weeks - 34 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Babies born between 26 and 34 weeks gestation

You may qualify if:

• Infants \< 6 hours of age who require NICU admission
• Infants 26+0 to 34+0 weeks gestation.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• The Physicians' Services Incorporated Foundation: collaborator
• Australian National University: collaborator

Study Sites (2)

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

Location

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

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

MeSH Terms

Conditions

Hypertension; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Erika Bariciak, MD

  The Ottawa Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2012
• First Posted: March 9, 2012
• Study Start: March 1, 2012
• Primary Completion: April 1, 2015
• Study Completion: October 1, 2015
• Last Updated: October 22, 2015

Record last verified: 2015-10

Locations

CA (2)