Promoting Healthy Brain Development: Wellness for 2 Study

February 17, 2025 updated by: Lauren Wakschlag, PhD, Northwestern University

Promoting Healthy Brain Development Via Prenatal Stress Reduction: an Innovative Precision Medicine Approach

The "Promoting Healthy Brain Project" (PHBP) is part of the Lurie Children's Hospital Strategic Research Initiative on Perinatal Origins of Childhood Disease: Research & Prevention at the Maternal-Fetal Interface. The overall purpose of the PHBP is to test whether reducing maternal stress during pregnancy is associated with improved neurodevelopment in the first year of life. This will be tested via a randomized controlled trial (n = 100) of a technology and mindfulness enhanced prenatal stress-reduction intervention (Mothers and Babies; MB).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The "Promoting Healthy Brain Project" (PHBP) aims to improve infant neurodevelopmental trajectories by intervening on the fetal environment. The PHBP will experimentally test whether reducing prenatal maternal stress is associated with improved neurodevelopment in the first year of life. A randomized controlled trial (RCT) of a technology and mindfulness-enhanced prenatal maternal stress-reduction intervention (The Mothers and Babies Course; MB), compared to usual prenatal care. Prospective evaluation of infant neurodevelopmental outcomes will take place through infant age 24 months. Participants assigned to the intervention group will be offered the 12-session MB intervention, a well-studied intervention that will include new mindfulness practice enhancements designed to promote practice of awareness and attention to the present moment. MB visits will be delivered 1-on-1 by a trained facilitator in an open and nonjudgmental way, and will be offered in-person, over the phone, and/or by video chat. Throughout the intervention, all participants (intervention group and control group) will also wear a wireless, "smart" health sensing device (BioStamp Sensor - nPoint Device) that will measure heart rate and motion. Mothers' heart rate variability and self-reported stress and emotion will be monitored using the BioStamp Sensor and brief smartphone surveys. For mothers in the intervention group, patterns of prolonged stress will trigger a "just-in-time adapted intervention" (JITAI) that will be delivered to mothers' smartphones. The booster intervention will include activities that will enhance skills learned in the MB course. All participants will complete self-report measures of prenatal maternal stress, emotion, depression, and skills related to the intervention (e.g., mindfulness). Infant neurodevelopmental health will be measured via brain and behavioral indicators of self-regulation, including performance-based indicators of executive function and corollary prefrontal cortex maturation and dimensional phenotypes of disruptive behavior, particularly irritability.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Ann & Robert H. Lurie Children's Hospital of Chicago
      • Chicago, Illinois, United States, 60611
        • Northwestern University (Feinberg School of Medicine)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • ≥ 18 years old;
  • enrolled under 22 weeks gestation;
  • receiving prenatal care from a Northwestern University prenatal care clinic & planning to deliver at Northwestern Hospitals;
  • English-speaking
  • Participants must own a smartphone and be must be willing to receive text messages and respond to short online surveys using their smartphone.
  • Eligible participants must also agree to wear a wireless adhesive sensor, the BioStamp, daily, throughout the 12-week MB course.
  • Eligible participants will also have WiFi internet access for the duration of their participation in the study, in order to complete online questionnaires and upload sensor data.
  • Eligible participants must also agree to have their child participate in the neurodevelopmental assessments from birth-12 months.

Exclusion Criteria:

  • Women will be ineligible to participate in this study if they have known pregnancy or chronic medical complications that may place their infant at risk for neurological disorders (e.g., HIV; acute cytomegalovirus infection (CMV); toxoplasmosis; zika virus; Phenylketonuria (PKU); chromosomal anomalies; metabolic disorder; substance use disorders) or significant mental health disorders (e.g., schizophrenia, bipolar disorder, psychosis) which could interfere with study adherence.
  • Participants unable to wear the BioStamp Sensor due to known skin sensitivity (e.g., allergy to adhesives or silicone), current skin irritation, or broken skin at the placement site will not be eligible to participate.
  • Participants with a pacemaker or other sensitive medical device will be excluded.
  • Women will not be eligible to participate if unable to provide informed consent, complete MB sessions, or complete study assessments in English.
  • Women who are currently participating in an MB course at the time of recruitment will not be eligible to participate.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention group
The first MB course session and technology training will take place in-person, prior to 23 weeks gestation. The Mothers and Babies course (MB) is a 12-session manualized stress-reduction intervention that will be delivered to participants, prenatally, with an integrated technology suite designed for timely detection and response to maternal stress. Sessions are delivered 1-on-1 with a trained facilitator and are based on principles of cognitive-behavioral therapy (CBT) and attachment theory. The MB course is divided into 3 sections: 1) Pleasant Activities; 2) Thoughts; 3) Contact with Others. Throughout each module, mindfulness skills training will be integrated as a strategy to help "center" participants. All participants will receive a Participant Manual for Families, containing worksheets that correspond to the 12 sessions.
Behavioral: Mothers and Babies (MB) Course
The Mothers and Babies course (MB) is a 12-session manualized stress-reduction intervention that will be delivered to participants, prenatally, with an integrated technology suite designed for timely detection and response to maternal stress.
Behavioral: Just in Time Intervention (JITI) Content
Participants will also receive additional MB intervention content in the form of "just-in-time" text messages, which will be sent to participants' smartphones every other day for up to 12 weeks. During the current trial, participants will receive text message prompts with links to additional stress reduction content based on a combination of their objective (sensor) and subjective (EMA) stress responses from the previous day.
Device: Biostamp nPoint Device
During the intervention period, participants will be asked to wear the BioStamp nPoint sensor, daily, while engaging in their usual activities (e.g., sleep, showering, exercise). The BioStamp Sensor is a thin, wearable patch, equipped with wireless high-range 6-axis gyroscope + accelerometer, and sEMG and ECG sensors, that adheres to the skin using a disposable medical-grade adhesive sticker (with adhesive similar to Band-Aid).
Active Comparator: Stress monitoring (control) group
This group will not receive any additional intervention but will engage in stress monitoring via biosensors and EMA text messages through the 14 week period
Device: Biostamp nPoint Device
During the intervention period, participants will be asked to wear the BioStamp nPoint sensor, daily, while engaging in their usual activities (e.g., sleep, showering, exercise). The BioStamp Sensor is a thin, wearable patch, equipped with wireless high-range 6-axis gyroscope + accelerometer, and sEMG and ECG sensors, that adheres to the skin using a disposable medical-grade adhesive sticker (with adhesive similar to Band-Aid).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
PROMIS Depression
Time Frame: Prenatal, 1 month, 3 months, 7 months, 12 months, 24 months
Mothers complete a 28-item scale that assesses depressive symptoms experienced in the past 7 days.
Prenatal, 1 month, 3 months, 7 months, 12 months, 24 months
Disruptive Behavior Diagnostic Observation Schedule (DB DOS)
Time Frame: 12 months, 24 months
The DB DOS is a standardized observation of infant arousal, soothability, reactivity, and temper loss. During early infancy, the
12 months, 24 months
State Trait Anxiety Inventory (STAI)
Time Frame: Prenatal, 1 month, 3 months, 7 months, 12 months, 24 months
The STAI is a 40 item self report questionnaire that assesses both state anxiety and trait anxiety.
Prenatal, 1 month, 3 months, 7 months, 12 months, 24 months
Perceived Stress Scale (PSS)
Time Frame: Prenatal, 1 month, 3 months, 7 months, 12 months, 24 months
The PSS is a self-report measure of the degree to which an individual perceives their life situations to be stressful. The instrument includes 10 items that assess how unpredictable, uncontrollable, and overloaded respondents find their lives, and assess current levels of experienced stress.
Prenatal, 1 month, 3 months, 7 months, 12 months, 24 months
MAP-DB
Time Frame: 1 month, 7 months, 12 months, 24 months
Parent report measure of infant irritability.
1 month, 7 months, 12 months, 24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Five Facet Mindfulness Questionnaire (FFMQ)
Time Frame: Prenatal, 1 month, 3 months, 7 months, 12 months, 24 months
The FFMQ is a 39-item self report survey that taps into five areas of mindfulness, including observation, description, aware actions, non-judgmental inner experience, and non-reactivity.
Prenatal, 1 month, 3 months, 7 months, 12 months, 24 months
NICU Neonatal Behavioral Scale (NNNS)
Time Frame: 1 month
The NNNS is an assessment of neurobehavioral organization, neurological reflexes, motor development - active and passive tone, and signs of stress and withdrawal in neonates, developed for use with at-risk or drug-exposed infants but has been normed with typically developing infants.
1 month
Test of Infant Motor Performance (TIMP)
Time Frame: 1 month
The TIMP is a norm-referenced measure designed to evaluate motor control and organization of posture and movement for functional activities in infants 32 weeks gestational age to four months post-term age and measures both spontaneous behaviors and elicited items.
1 month
General Movements Assessment (GMA)
Time Frame: 1 month
General movements are a developmentally regulated pattern of spontaneous motor activity. By 10-15 weeks of age, the predominant general movements seen are called Fidgety Movements - a pattern of continuous, small amplitude movements of the neck, trunk and limbs during wakefulness that disappear with agitation. These patterns are identifiable and are classified as normal if present (intermittent or continual), and abnormal if exaggerated (with respect to speed and amplitude), sporadic (interspersed with long pauses) or absent. Babies are observed for up to 30 minutes in a supine position to assess for spontaneous movements.
1 month
Alberta Infant Motor Scale (AIMS)
Time Frame: 1 month
The Alberta Infant Motor Scale (AIMS) is a 10-20 minute norm referenced, standardized, gross motor assessment. Infants are observed in four positions: prone, sitting, supine, and standing. For each subscale, items are scored as "observed" or "not observed". A total raw score and percentile are calculated.
1 month
Maternal Heart Rate Variability
Time Frame: Pregnancy (duration 14 weeks)
variability/physiological stress as indicated by a machine learned model applied to electrocardiogram (ECG) signals.
Pregnancy (duration 14 weeks)
Prefrontal cortex thickness
Time Frame: 1 month, 12 months, 24 months
Cortical thickness and surface area of pre-frontal cortex regions, which have been linked to child irritability and Infant dysregulation, is measured through natural sleep MRI.
1 month, 12 months, 24 months
Inflammatory and neuroimmune biomarkers
Time Frame: At birth
Placenta and cord blood will be collected at birth. Tests to be performed on these samples include measurement of inflammatory markers related to stress, such as a multiplex immunoassay panel of the following cytokines and chemokines: (IL-6, IL-8, IL-10, C-reactive protein, TNF-alpha, TGF-beta, IL-1beta, procalcitonin, cortisol).
At birth
EEG power
Time Frame: 1 month, 12 months, 24 months
The baby will complete a baseline or resting EEG for 2-5 minutes and then hear an auditory oddball paradigm with speech syllables while resting for ~10 min. EEG (electroencephalogram) power will be measured as a marker infant neurodevelopment.
1 month, 12 months, 24 months
ERP mean amplitude
Time Frame: 1 month, 12 months, 24 months
The baby will complete a baseline or resting EEG for 2-5 minutes and then hear an auditory oddball paradigm with speech syllables while resting for ~10 min. ERP (event related potential) mean amplitude will be measured as a marker of infant neurodevelopment.
1 month, 12 months, 24 months
Birthweight
Time Frame: Birth
Infant birthweight will be obtained from EHR data collected at the hospital at birth
Birth
Maternal Infant Responsiveness Instrument (MIRI)
Time Frame: 1 month, 7 months, 12 months
The MIRI is a 22 item questionnaire designed to assess a mother's feelings about her infant, her recognition of her responsiveness to the infant, and her infants responses.
1 month, 7 months, 12 months
Infant Behavior Questionnaire-Revised (IBQ-R) short form
Time Frame: 1 month, 7 months, 12 months
The IBQ-R is a parent-report survey designed to measure multiple dimensions of temperament in infants up to age 12 months.
1 month, 7 months, 12 months
Bayley Scales of Infant Development
Time Frame: 7 months, 12 months, 24 months
The Bayley Scales of Infant and Toddler Development Fourth Edition (Bayley-4) is a five-domain assessment tool used to determine developmental delays in children. The developmental domains are cognitive, language, motor, social-emotional, and adaptive behavior, and include direct assessment of the child and parent report.
7 months, 12 months, 24 months
Preschool Age Psychiatric Assessment (PAPA)
Time Frame: 24 months
Parent structured interview for diagnosing psychiatric disorders in children ages 2-5.
24 months
Brief Infant Toddler Social Emotional Assessment (BITSEA)
Time Frame: 12 months, 24 months
Parent report measure of behavior problems and social competencies in children ages 1-3 that identifies delays or deficits in areas of social-emotional development.
12 months, 24 months
Early Childhood Irritability Related Impairment Interview (E-CRI)
Time Frame: 24 months
The E-CRI is a semi-structured interview designed to measure early childhood impairment resulting from young children's tantrums and irritability across various contexts.
24 months
Perceived Stress Scale (PSS)
Time Frame: 1 month, 3 months, 7 months, 12 months, 24 months
Self-report measure of the degree to which an individual perceives their life situations to be stressful. The instrument includes 10 items that assess how unpredictable, uncontrollable, and overloaded respondents find their lives, and assess current levels of experienced stress.
1 month, 3 months, 7 months, 12 months, 24 months
Behavioral Activation Depression Scale (BADS) - short form
Time Frame: prenatal, 3 months, 7 months, 12 months, 24 months
Self-report 9-item measure of behaviors that indicate depression and can be targeted for change by cognitive behavioral therapy and behavior activation. Mothers complete this measure regarding behaviors experienced over the past week.
prenatal, 3 months, 7 months, 12 months, 24 months
Negative Mood Regulation Scale (NMRS)
Time Frame: prenatal, 3 months, 7 months, 12 months, 24 months
This self-report, 30-item scale measures expectancies and beliefs that the mothers have regarding their abilities to alleviate their negative mood, anger, anxiety and depression.
prenatal, 3 months, 7 months, 12 months, 24 months
Parenting Stress Index (PSI) - Role Restriction Subscale
Time Frame: 3 months, 7 months, 12 months, 24 months
The PSI Role Restriction subscale includes 7 mother-report items regarding her feelings of limited freedom and restriction of her identity to the parenting role.
3 months, 7 months, 12 months, 24 months
Parental Cognitions and Conduct Toward the Infant Scale (PACOTIS)
Time Frame: 1 month, 3 months, 7 months, and 12 months
The PACOTIS is a mother report measure of their actions, thoughts, and feelings during interactions with their baby.
1 month, 3 months, 7 months, and 12 months
MacArthur-Bates Communicative Development Inventories (MCDI)
Time Frame: 12 months, 24 months
The MCDI is a parent-report questionnaire about their child's communication and language development. The Words & Gestures form is used at 12 months and the Words & Sentences form is used at 24 months.
12 months, 24 months
Medical Outcomes Study (MOS) Social Support Survey
Time Frame: Prenatal, 3 months, 7 months, 12 months, 24 months
The MOS Social Support Survey is a 19-item self-report measure of the mother's availability of social support in a variety of domains including emotional support, tangible support, affectionate support, and positive social interaction.
Prenatal, 3 months, 7 months, 12 months, 24 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Family Life Impairment Scale (FLIS)
Time Frame: 12 months, 24 months
The FLIS is a parent report survey that assesses the degree to which a child's behavior impacts the family's ability to participate in typical activities.
12 months, 24 months
PROMIS Anxiety
Time Frame: Prenatal, 1 month, 3 months, 7 months, 12 months, 24 months
Mothers complete the PROMIS Anxiety scale, which includes items that assess fear, anxious misery, hyperarousal, and somatic symptoms related to anxiety.
Prenatal, 1 month, 3 months, 7 months, 12 months, 24 months
Family Relationship Index (FRI)
Time Frame: prenatal, 3 months, 7 months, 12 months, 24 months
The FRI is a 12-item survey designed to assess family cohesion, communication and conflict-resolution.
prenatal, 3 months, 7 months, 12 months, 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Northwestern University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ann & Robert H Lurie Children's Hospital of Chicago

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lauren Wakschlag, PhD, Northwestern University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 15, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 28, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 30, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 11, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 22, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB 2019-2515

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified data will be shared with other investigators. Investigators from outside the study will be asked to sign an agreement of confidentiality in order to receive the data requested. Data will be stored for at least 7 years. We plan to archive the de-identified data in a data repository for future use by other researchers, after the study is completed. Additionally, data from this study will be used in the Mental Health Earlier Synthetic Cohort (MHESC) Study in order to generate a pragmatic clinical risk calculator to predict preschool psychopathology. MHESC pools three extramural cohorts at Northwestern University and Washington University in St. Louis, one of which is the Wellness for 2 Study to form a clinically enriched "synthetic" cohort. Therefore, data will be shared with authorized individuals at Washington University.

IPD Sharing Time Frame

Data will be stored for at least 7 years.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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