Cardiovascular Effects of Prenatal Methamphetamine Exposure

University of California, Davis26 enrolled

Overview

Methamphetamine (MA) is one of the commonly used drugs during pregnancy. Cardiovascular effects of MA include elevated blood pressure, acute vasospasm, atherosclerotic disease, structural and electrical remodeling of cardiac tissue leading to arrhythmias and heart failure, and pulmonary hypertension.1 In addition, MA can cause neurotoxicity with harmful effects on neurodevelopment in the children who had prenatal exposure.5-8 Currently neonatal providers do not perform detailed cardiovascular evaluation in newborn period or long term neurodevelopmental assessments as outpatient for the newly born infants with prenatal exposure to MA, and they do not qualify for early intervention. The goal of the investigators is to perform detailed cardiovascular evaluation in neonatal period and estimate baseline prevalences and follow up with developmental and cardiovascular assessment using a questionnaire at 12 months in a cohort of neonates enriched with those who had prenatal exposure to MA.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Methamphetamine Abuse Newborn Complication &#X7C; Patient &#X7C; Neonatalology

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Infants born at UCDCH and at AHRO at gestational age \>34 weeks. (\<34 weeks excluded to avoid the effects of prematurity) 2. For the MA exposed subgroup (n=30): Infants born to mothers with prenatal history of MA use during current pregnancy and/or positive meconium toxicology positive for MA in infant. 3. For the MA unexposed subgroup (n=12): Infants born to mothers without prenatal history of MA use during this pregnancy and negative meconium toxicology for MA in infant. Exclusion Criteria: a) Presence of congenital anomalies and known fatal conditions.

Outcomes

Primary Outcomes

Estimation of prevalence of MA use among births

Time frame: Through study completion, an average of 2 years.

Evaluation of effects of prenatal MA exposure on neonatal cardiovascular status.

Perfusion index by pulse-oximeter, heart function by echocardiogram, EKG and detailed cardiac exam in the newborn period between 24-48 hours after birth.

Time frame: Through study completion, an average of 2 years.

Secondary Outcomes

Infant's neurodevelopmental outcome and general assessment at 12 months of age.

Phone call with parent to assess the infant's neurodevelopment at 12 months of age using "Ages and Stages" questionnaire with parent and/or pediatrician, assessment of general health, nutrition and cardiovascular status (BP measurement) by phone call with pediatrician

Time frame: Through study completion, an average of 2 years.

Cardiovascular Effects of Prenatal Methamphetamine Exposure

Overview

Conditions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes