Cardiovascular Effects of Prenatal Methamphetamine Exposure
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Methamphetamine exposed 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 Infants born to mothers without prenatal history of MA use during this pregnancy and negative meconium toxicology for MA in infant. |
Outcome Measures
Primary Outcome Measures
- 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. [Through study completion, an average of 2 years.]
Perfusion index by pulse-oximeter, heart function by echocardiogram, EKG and detailed cardiac exam in the newborn period between 24-48 hours after birth.
Secondary Outcome Measures
- Infant's neurodevelopmental outcome and general assessment at 12 months of age. [Through study completion, an average of 2 years.]
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
Eligibility Criteria
Criteria
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:
- Presence of congenital anomalies and known fatal conditions.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Adventist Health and Rideout | Marysville | California | United States | 95901 |
| 2 | UC Davis Children's Hospital | Sacramento | California | United States | 95817 |
Sponsors and Collaborators
- University of California, Davis
- Adventist Health and Rideout
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 1632548