Methamphetamine AbuseNCT04616625
Cardiovascular Effects of Prenatal Methamphetamine Exposure
An observational study of Methamphetamine Abuse and Newborn Complication | Patient | Neonatalology, run by University of California, Davis at 2 sites in United States.
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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Methamphetamine Abuse, Newborn Complication | Patient | Neonatalology
- How many people
- 26 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Oct 2020to 30 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Infants born at UCDCH and at AHRO at gestational age >34 weeks. (<34 weeks excluded to avoid the effects of prematurity)
Who may be able to join
- 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.
Who cannot join
- Presence of congenital anomalies and known fatal conditions.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Adventist Health and Rideout
Marysville, California, 95901
UC Davis Children's Hospital
Sacramento, California, 95817
About this study
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, Methamphetamine in pregnancy, Cardiovascular effects of methamphetamine on newborn, Effect of prenatal methamphetamine exposure on neurodevelopment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimation of prevalence of MA use among births
Measured: 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.
Measured: Through study completion, an average of 2 years.
Secondary outcomes (1)
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
Measured: Through study completion, an average of 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2020
- Study start5 Oct 2020
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Methamphetamine AbuseStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- Adventist Health and Rideout
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04616625
- Sponsor's protocol ID
- 1632548
- Status last verified
- Oct 2024
- First submitted
- 8 Oct 2020
- Last updated
- 1 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Effects of Prenatal Methamphetamine Exposure
- ClinicalTrials.gov ID
- NCT04616625
- Acronym / sponsor ID
- 1632548
- Keywords
- Methamphetamine, Methamphetamine in pregnancy, Cardiovascular effects of methamphetamine on newborn, Effect of prenatal methamphetamine exposure on neurodevelopment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- Adventist Health and Rideout
- Study start
- 5 Oct 2020 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 5 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Infants born at UCDCH and at AHRO at gestational age >34 weeks. (<34 weeks excluded to avoid the effects of prematurity)
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Presence of congenital anomalies and known fatal conditions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Estimation of prevalence of MA use among births
Time frame: Through study completion, an average of 2 years.
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.
1 secondary outcome
Infant's neurodevelopmental outcome and general assessment at 12 months of age.
Time frame: Through study completion, an average of 2 years.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2024.
- Learn more or sign up for the study here!Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Methamphetamine Abuse and Newborn Complication | Patient | Neonatalology, run by University of California, Davis at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimation of prevalence of MA use among births (time frame: Through study completion, an average of 2 years.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2024.