Cardiovascular Effects of Prenatal Methamphetamine Exposure

Completed

• Conditions: Newborn Complication | Patient | Neonatalology; Methamphetamine Abuse

• Registration Number: NCT04616625
• Lead Sponsor: University of California, Davis

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-05
• Study First Submitted: 2020-10-08
• Study First Submitted QC: 2020-10-29
• Study First Posted: 2020-11-05
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-30
• Last Update Posted: 2024-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.
Estimation of prevalence of MA use among births	Through study completion, an average of 2 years.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Adventist Health and Rideout; 🇺🇸 Marysville, California, United States

UC Davis Children's Hospital; 🇺🇸 Sacramento, California, United States