Cardiovascular Effects of Prenatal Methamphetamine Exposure

Methamphetamine Abuse Clinical Trial

Official title:

Cardiovascular Effects of Prenatal Methamphetamine Exposure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04616625
• Other study ID #: 1632548
• Status: Recruiting
• Start date: October 5, 2020
• Est. completion date: June 30, 2023

Study information

• Verified date: November 2022
• Source: University of California, Davis
• Contact: Deepika Sankaran, MD
• Phone: 3477410372
• Email: dsankaran[@]ucdavis.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United States	Adventist Health and Rideout	Marysville	California
United States	UC Davis Children's Hospital	Sacramento	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Davis	Adventist Health and Rideout

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimation of prevalence of MA use among births		Through study completion, an average of 2 years.
Primary	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	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.

External Links

•   Learn more or sign up for the study here!