NCT04616625

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2020

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 5, 2020

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

October 8, 2020

Completed
28 days until next milestone

First Posted

Study publicly available on registry

November 5, 2020

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

November 1, 2024

Status Verified

October 1, 2024

Enrollment Period

2.7 years

First QC Date

October 8, 2020

Last Update Submit

October 30, 2024

Conditions

Methamphetamine AbuseNewborn Complication | Patient | Neonatalology

Keywords

MethamphetamineMethamphetamine in pregnancyCardiovascular effects of methamphetamine on newbornEffect of prenatal methamphetamine exposure on neurodevelopment

Outcome Measures

Primary Outcomes (2)

  • Estimation of prevalence of MA use among births

    Through study completion, an average of 2 years.

  • 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 Outcomes (1)

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

    Through study completion, an average of 2 years.

Study Arms (2)

Methamphetamine exposed

Infants born to mothers with prenatal history of MA use during current pregnancy and/or positive meconium toxicology positive for MA in infant.

Methamphetamine non-exposed

Infants born to mothers without prenatal history of MA use during this pregnancy and negative meconium toxicology for MA in infant.

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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)

You may qualify if:

  • 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.

You may not qualify if:

  • a) Presence of congenital anomalies and known fatal conditions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Adventist Health and Rideout

Marysville, California, 95901, United States

Location

UC Davis Children's Hospital

Sacramento, California, 95817, United States

Location

Related Links

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2020

First Posted

November 5, 2020

Study Start

October 5, 2020

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

November 1, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

US(2)