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Completed

NCT Number: NCT04616625

Cardiovascular Effects of Prenatal Methamphetamine Exposure

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.

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Key information

Conditions

Methamphetamine Abuse Newborn Complication | Patient | Neonatalology

Sex eligibility

All sexes

Study type

Observational

Primary location

Adventist Health and Rideout, Marysville, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

a) Presence of congenital anomalies and known fatal conditions.

Treatment and study plan

Primary outcomes

  1. Estimation of prevalence of MA use among births

    Time frame: Through study completion, an average of 2 years.

  2. Evaluation of effects of prenatal MA exposure on neonatal cardiovascular status.

    Time frame: 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 outcomes

  1. Infant's neurodevelopmental outcome and general assessment at 12 months of age.

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Collaborators

  • Adventist Health and Rideout

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Nov 5, 2020
Registry last updated
Nov 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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