Cardiovascular Effects of Prenatal Methamphetamine Exposure

Study Overview
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Brief Summary
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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.

Official Title
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Cardiovascular Effects of Prenatal Methamphetamine Exposure

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

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infants born at UCDCH and at AHRO at gestational age >34 weeks. (<34 weeks excluded to avoid the effects of prematurity) 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. 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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Methamphetamine exposed<br>Infants born to mothers with prenatal history of MA use during current pregnancy and/or positive meconium toxicology positive for MA in infant. | |
| Methamphetamine non-exposed<br>Infants born to mothers without prenatal history of MA use during this pregnancy and negative meconium toxicology for MA in infant. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimation of prevalence of MA use among births |  | 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. | Through study completion, an average of 2 years. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Through study completion, an average of 2 years. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Methamphetamine, Methamphetamine in pregnancy, Cardiovascular effects of methamphetamine on newborn, Effect of prenatal methamphetamine exposure on neurodevelopment