Clinical trial NCT04616625: Cardiovascular Effects of Prenatal Methamphetamine Exposure
Official title: Cardiovascular Effects of Prenatal Methamphetamine Exposure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Methamphetamine Abuse
Newborn Complication &#X7C; Patient &#X7C; Neonatalology
Keywords: Methamphetamine
Methamphetamine in pregnancy
Cardiovascular effects of methamphetamine on newborn
Effect of prenatal methamphetamine exposure on neurodevelopment
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: Adventist Health and Rideout
First posted: 2020-11-05
Enrollment: 26
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants born at UCDCH and at AHRO at gestational age \>34 weeks. (\<34 weeks excluded to avoid the effects of prematurity)

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Estimation of prevalence of MA use among births
timeFrame: Through study completion, an average of 2 years.
measure: Evaluation of effects of prenatal MA exposure on neonatal cardiovascular status.
timeFrame: Through study completion, an average of 2 years.
Secondary outcomes:
measure: Infant's neurodevelopmental outcome and general assessment at 12 months of age.
timeFrame: Through study completion, an average of 2 years.
Other outcomes:
Locations:
city: Marysville
country: United States
facility: Adventist Health and Rideout
state: California
city: Sacramento
country: United States
facility: UC Davis Children's Hospital
state: California
Study officials:
References: