Summary

Healthy Volunteers
healthy people welcome
Location
at Sacramento, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Deepika Sankaran, MD

Description

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.

Keywords

Methamphetamine Abuse Newborn Complication | Patient | Neonatalology Methamphetamine Methamphetamine in pregnancy Cardiovascular effects of methamphetamine on newborn Effect of prenatal methamphetamine exposure on neurodevelopment Methamphetamine exposed Methamphetamine non-exposed

Eligibility

You can join if…

  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.

You CAN'T join if...

a) Presence of congenital anomalies and known fatal conditions.

Locations

  • UC Davis Children's Hospital not yet accepting patients
    Sacramento California 95817 United States
  • Adventist Health and Rideout accepting new patients
    Marysville California 95901 United States

Lead Scientist at UC Davis

  • Deepika Sankaran, MD
    Assistant Professor, Pediatrics. Authored (or co-authored) 13 research publications.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Davis
Links
Sign up for this study
ID
NCT04616625
Study Type
Observational
Last Updated