Effect of Support for Low-Income Mothers of Preterm Infants

January 6, 2026 updated by: Margaret Parker, University of Massachusetts, Worcester

Effect of Support for Low-Income Mothers of Preterm Infants on Parental Caregiving in the Neonatal Intensive Care Unit (NICU)

Preterm birth is a leading cause of childhood mortality and developmental disabilities. Socioeconomic disparities in the incidence of preterm birth and morbidities, mortality, and quality of care for preterm infants persist. An important predictor of the long-term consequences of preterm birth is maternal presence during the prolonged infant hospitalization (weeks to months) in the neonatal intensive care unit (NICU). Mothers who visit the NICU can pump breast milk, directly breastfeed and engage in skin-to-skin care, which facilitates breast milk production and promotes infant physiologic stability and neurodevelopment. Low-income mothers face significant barriers to frequent NICU visits, including financial burdens and the psychological impact of financial stress, which hinder their participation in caregiving activities. The investigators will conduct an randomized controlled trial (RCT) to test the effectiveness of financial transfers among 420 Medicaid - eligible mothers with infants 24 - 34 weeks' gestation in four level 3 NICUs: Boston Medical Center (BMC) in Boston, Massachusetts, UMass Memorial Medical Center (UMass) in Worcester, Massachusetts, Baystate Medical Center in Springfield, Massachusetts, and Grady Memorial Hospital in Atlanta, Georgia. Mothers in the intervention arm will receive usual care enhanced with weekly financial transfers and will be informed that these transfers are meant to help them spend more time with their infant in the NICU vs. a control arm (usual care). We received supplemental funding to extend analyses to include extended postpartum maternal health outcomes. The original sample size of 420 remains the basis for the parent trial's primary and secondary NICU caregiving outcomes, while the supplemental funding (effective January 2026) enables analysis of secondary maternal health outcomes up to 12 months postpartum using an expanded analytic cohort. The primary hypothesis is that financial transfers can enable economically disadvantaged mothers to visit the NICU, reduce the negative psychological impacts of financial distress, and increase maternal caregiving behaviors associated with positive preterm infant health and development.

Study Overview

Status

Status

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

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.

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 (Estimated)

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.
420

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Mother is eligible for Medicaid insurance.
  • Has an infant or infants born 24 0/7-34 1/7 weeks gestation.
  • Mother's baby is cared for at one of the four enrolling study sites located in Massachusetts or Georgia.
  • Mother is eligible to breastfeed (per hospital criteria).

Exclusion Criteria:

  • Mother is not English- or Spanish-speaking.

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

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.
No Intervention: Usual Care
Experimental: Financial Transfers
Mothers assigned to the intervention group will be informed that they are eligible to receive financial transfers $160/week on a "CuddleCard" debit-card with a one- time "label" or scripted message that states: "This money is intended to help you to spend more time visiting and caring for your infant(s) in the NICU." Financial transfers will begin 1 week after birth or when the mother is discharged (whichever comes later) until the infant is discharged, except in cases where the hospitalization lasts beyond 42 weeks corrected age.
Other: Financial Transfers
Mothers assigned to the intervention group will be informed that they are eligible to receive financial transfers $160/week on a debit-card with a one-time "label" or scripted message that states: "This money is intended to help you to spend more time visiting and caring for your infant(s) in the NICU." Financial transfers will begin 1 week after birth or when the mother is discharged (whichever comes later) until the infant is discharged, except in cases where the hospitalization lasts beyond 42 weeks corrected age.

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
Provision of breast milk (proportion)
Time Frame: From NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks)
Proportion of nursing shift-total enteral intake that is maternal breast milk fed via gavage tube or bottle.
From NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks)
Provision of skin-to-skin care
Time Frame: From NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks)
Proportion of nursing shifts where mother performs skin-to-skin care for at least one hour.
From NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks)

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
Gestational weight-for-age
Time Frame: Extracted from medical records 1-2 weeks after discharge from the NICU
Change in sex-specific gestational weight-for-age z-score while admitted to the NICU.
Extracted from medical records 1-2 weeks after discharge from the NICU
Gestational length-for-age z-score
Time Frame: Extracted from medical records 1-2 weeks after discharge from the NICU
Change in sex-specific gestational length-for-age z-score while admitted to the NICU.
Extracted from medical records 1-2 weeks after discharge from the NICU
Gestational head circumference
Time Frame: Extracted from medical records 1-2 weeks after discharge from the NICU
Change in sex-specific gestational head circumference z-score while admitted to the NICU.
Extracted from medical records 1-2 weeks after discharge from the NICU
Necrotizing enterocolitis (NEC)
Time Frame: Extracted from medical records 1-2 weeks after discharge from the NICU
Experienced NEC during NICU stay according to Vermont Oxford Network (VON) definition; criteria: yes/no.
Extracted from medical records 1-2 weeks after discharge from the NICU
Late-onset bacterial or fungal sepsis (LOS)
Time Frame: Extracted from medical records 1-2 weeks after discharge from the NICU
Experienced with LOS during NICU stay according to Vermont Oxford Network (VON) definition; criteria: yes/no.
Extracted from medical records 1-2 weeks after discharge from the NICU
NICU Visitation
Time Frame: From NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks)
Proportion of nursing shifts where mother is present in the NICU.
From NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks)
Postpartum Bonding
Time Frame: Measured in the post-discharge survey within 4-8 week of infant discharge
Score of mother-infant bonding assessed inspired by the Postpartum Bonding Questionnaire, where participants rate their agreement of statements on Likert scales ranging from 0 (always) to 5 (never); scores range from 0 to 50, with higher scores indicating more bonding challenges.
Measured in the post-discharge survey within 4-8 week of infant discharge
Provision of breast milk (volume)
Time Frame: From NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks)
Milliliters of nursing shift-total enteral intake that is maternal breast milk fed via gavage tube or bottle.
From NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks)
Breastfeeding episode
Time Frame: From NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks)
Occurrence of direct breastfeeding episode during each nursing shift.
From NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks)
Length of stay
Time Frame: Measured within one week of discharge form the NICU
The total number of days from infant admission to discharge from the hospital.
Measured within one week of discharge form the NICU
Mother readmission between 4-8 weeks post-discharge
Time Frame: Measured between 4-8 weeks after discharge of infant from NICU
Any mother readmission to the hospital after her initial discharge.
Measured between 4-8 weeks after discharge of infant from NICU
Baby readmission between 4-8 weeks post-discharge
Time Frame: Measured between 4-8 weeks after discharge of infant from NICU
Any infant readmission to the hospital after initial discharge.
Measured between 4-8 weeks after discharge of infant from NICU
Sleep position
Time Frame: Measured between 4-8 weeks after discharge of infant from NICU
Mothers report of exclusive infant supine position to sleep in the last two weeks.
Measured between 4-8 weeks after discharge of infant from NICU
Sleep location
Time Frame: Measured between 4-8 weeks after discharge of infant from NICU
Mothers report exclusively using the room-sharing sleep method, where the infant sleeps in the same room as an adult but on a separate crib or sleep surface, without bed-sharing, in the last two weeks.
Measured between 4-8 weeks after discharge of infant from NICU
Breastfeeding expression continuation
Time Frame: Measured between 4-8 weeks after discharge of infant from NICU
Mothers report of breastfeeding continuation.
Measured between 4-8 weeks after discharge of infant from NICU
Skin-to-skin care knowledge
Time Frame: Measured within one week of discharge form the NICU
Mothers report of knowledge about Skin-to-skin (STS) care based on 4 questions. Scored as a count variable that ranges between 0 and 4.
Measured within one week of discharge form the NICU
Breastfeeding knowledge
Time Frame: Measured within one week of discharge form the NICU
Mothers report of knowledge about breastfeeding based on 7 questions. Scored as a count variable that ranges between 0 and 7.
Measured within one week of discharge form the NICU
Perception of hospital experience
Time Frame: Measured between 4-8 weeks after discharge of infant from NICU
Assesses mothers' overall perception of hospital experience and hospital services during their stay, using a scale from 0 (worst hospital possible) to 10 (best hospital possible).
Measured between 4-8 weeks after discharge of infant from NICU
Reaction Time Attention Network Test-Revised (ANT-R).
Time Frame: Measured biweekly from NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks)
Average response time across all trials to assess overall speed of responses. Lower scores indicate faster reaction times and better attentional performance.
Measured biweekly from NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks)
Accuracy Performance Attention Network Test-Revised (ANT-R).
Time Frame: Measured biweekly from NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks)
Proportion of accurate responses on the ANT-R. Higher scores indicate higher accurate responses.
Measured biweekly from NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks)
Reaction Time Psychomotor Vigilance Task
Time Frame: Measured biweekly from NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks)
Average reaction time across trials, assessing overall speed and vigilance. Lower scores indicate quicker reaction times and heightened vigilance.
Measured biweekly from NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks)
Accuracy Psychomotor Vigilance Task
Time Frame: Measured biweekly from NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks)
Percentage of correct responses out of the total number of trials on the Psychomotor Vigilance Task (PVT). Higher scores indicate higher accurate responses.
Measured biweekly from NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks)
Duration of mother's milk expression
Time Frame: From NICU admission through to 12 months postpartum
Months of milk expression via direct breastfeeding or pumping.
From NICU admission through to 12 months postpartum
Maternal physical health
Time Frame: Measured biweekly from NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks); post-discharge (4-8 weeks); 6 months postpartum; 12 months postpartum
Score of self-reported Short Form Health Survey -1 Physical Health Item; assesses participants' perception of their current physical health. Lower score indicates worse perceived physical health.
Measured biweekly from NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks); post-discharge (4-8 weeks); 6 months postpartum; 12 months postpartum
Maternal mental health (anxiety)
Time Frame: Measured biweekly from NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks); post-discharge (4-8 weeks); 6 months postpartum; 12 months postpartum
Score of self-reported 10-item Perceived Stress Scale (PSS-10); assesses the perceived stress levels experienced in terms of overstrain, unmanageability, and unpredictability in the past month. Higher score indicates worse outcome.
Measured biweekly from NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks); post-discharge (4-8 weeks); 6 months postpartum; 12 months postpartum
Maternal mental health (depression)
Time Frame: Measured biweekly from NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks); post-discharge (4-8 weeks); 6 months postpartum; 12 months postpartum
Score of the Edinburgh Postnatal Depression Scale (EPDS), a 10-item self-report measure of postpartum depression (ranges from 0-30) with a higher score indicating worse depressive symptoms. The EPDS was developed to assist health professionals in detecting mothers suffering from postpartum depression (PPD).
Measured biweekly from NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks); post-discharge (4-8 weeks); 6 months postpartum; 12 months postpartum
Happiness
Time Frame: Measured biweekly from NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks); post-discharge (4-8 weeks); 6 months postpartum; 12 months postpartum
Score on Happiness Indicator from Integrated Values Surveys; assesses the overall and current perceived level of happiness experienced; with a 4-point scale from 0 (Not at all happy) to 3 (Very Happy). Higher score indicates better perceived level of happiness.
Measured biweekly from NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks); post-discharge (4-8 weeks); 6 months postpartum; 12 months postpartum
Life satisfaction
Time Frame: Measured biweekly from NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks); post-discharge (4-8 weeks); 6 months postpartum; 12 months postpartum
Score of the Life Satisfaction Scale Item; assesses participants' perception of their current overall life satisfaction; with a 4-point scale from 0 (Very Satisfied) to 3 (Not At All Satisfied), and was reverse-coded such that higher scores indicate better perceived life satisfaction.
Measured biweekly from NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks); post-discharge (4-8 weeks); 6 months postpartum; 12 months postpartum
Sleep
Time Frame: Measured biweekly from NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks); post-discharge (4-8 weeks); 6 months postpartum; 12 months postpartum
Score of Sleep Quality Score (SQS) with 7-Day Recall; evaluates the overall quality of sleep. Core components include sleep duration, ease of falling asleep, frequency of waking during the night (excluding bathroom visits), early waking, and sleep refreshment. The respondent marks an integer score from 0 to 10, according to the following five categories: 0 = terrible, 1-3 = poor, 4-6 = fair, 7-9 = good, and 10 = excellent. Higher score indicates better perceived sleep quality.
Measured biweekly from NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks); post-discharge (4-8 weeks); 6 months postpartum; 12 months postpartum
Routine postpartum care
Time Frame: Measured at post-discharge (4-8 weeks after infant discharge from NICU); 6 months postpartum; 12 months postpartum
Number of routine postpartum follow-up visits attended by mom.
Measured at post-discharge (4-8 weeks after infant discharge from NICU); 6 months postpartum; 12 months postpartum
Financial distress
Time Frame: Measured biweekly from NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks); post-discharge (4-8 weeks); 6 months postpartum; 12 months postpartum
Score of financial stress during the NICU stay based on two metrics: difficulty in paying bills and remaining money at the end of the week. Scoring for each question is summed to create an overall financial distress score, ranging from 0 to 8. Higher score indicates higher financial distress.
Measured biweekly from NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks); post-discharge (4-8 weeks); 6 months postpartum; 12 months postpartum
Financial hardship
Time Frame: Measured within one week of discharge form the NICU; post-discharge (4-8 weeks); 6 months postpartum; 12 months postpartum
Score of financial hardships experienced during the NICU stay, including using up all savings, taking out loans, borrowing from friends, incurring debt, being threatened by eviction, or having a shut-off of an energy utility. Scoring for each question is yes/no and is summed to create an overall score that ranges between 0 and 6.
Measured within one week of discharge form the NICU; post-discharge (4-8 weeks); 6 months postpartum; 12 months postpartum
Food insecurity
Time Frame: Measured biweekly from NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks); post-discharge (4-8 weeks); 6 months postpartum; 12 months postpartum
Score of Food Insecurity Screening Tool; assesses the risk of food insecurity (availability and affordability) in households based on questions derived from the U.S. Household Food Security Survey Module. Response options include: "Often True," "Sometimes True," "Never True". An affirmative response on either item will be considered to be positive for food insecurity.
Measured biweekly from NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks); post-discharge (4-8 weeks); 6 months postpartum; 12 months postpartum
Housing instability
Time Frame: Measured within one week of discharge form the NICU; post-discharge (4-8 weeks); 6 months postpartum; 12 months postpartum
Number of moves family has made since their child's birth.
Measured within one week of discharge form the NICU; post-discharge (4-8 weeks); 6 months postpartum; 12 months postpartum
Housing insecurity
Time Frame: Measured within one week of discharge form the NICU; post-discharge (4-8 weeks); 6 months postpartum; 12 months postpartum
Score on housing insecurity scale; assesses participants' worry that they may not have stable housing in the next 2 months. Likert scales ranging from 0 (not at all worried) to 3 (very worried). Higher scores indicate greater levels of housing insecurity.
Measured within one week of discharge form the NICU; post-discharge (4-8 weeks); 6 months postpartum; 12 months postpartum
Transportation insecurity
Time Frame: Measured biweekly from NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks); post-discharge (4-8 weeks); 6 months postpartum; 12 months postpartum
Score on transportation insecurity item; assesses participants' experience of transportation-related issues affecting their ability to visit the NICU. Likert scales ranging from 0 (never) to 3 (always). Higher scores indicate greater levels of transportation insecurity.
Measured biweekly from NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks); post-discharge (4-8 weeks); 6 months postpartum; 12 months postpartum
Mother emergency department visit post-discharge
Time Frame: Measured at post-discharge survey (4-8 weeks after infant discharge from NICU); 6 months postpartum; 12 months postpartum
The number of emergency department visits by the mother in the postpartum period.
Measured at post-discharge survey (4-8 weeks after infant discharge from NICU); 6 months postpartum; 12 months postpartum
Baby emergency department visit weeks post-discharge
Time Frame: Measured at post-discharge survey (4-8 weeks after infant discharge from NICU); 6 months postpartum; 12 months postpartum
The number of emergency department visits by the infant after discharge.
Measured at post-discharge survey (4-8 weeks after infant discharge from NICU); 6 months postpartum; 12 months postpartum
Life's Essential 8 (LE8) behavioral cardiovascular health score
Time Frame: Measured at pre-discharge; post-discharge (4-8 weeks, where all components are available); 6 months postpartum; 12 months postpartum
Composite score (0-100) based on four behavioral components: diet quality, physical activity, sleep health, and nicotine exposure, scored according to American Heart Association Life's Essential 8 criteria.
Measured at pre-discharge; post-discharge (4-8 weeks, where all components are available); 6 months postpartum; 12 months postpartum
Primary care utilization in the postpartum period
Time Frame: Measured at post-discharge (4-8 weeks); 6 months postpartum; 12 months postpartum
Number of visits with a primary care provider for routine or sick care.
Measured at post-discharge (4-8 weeks); 6 months postpartum; 12 months postpartum
Adherence to recommended care for chronic conditions
Time Frame: Measured at post-discharge (4-8 weeks); 6 months postpartum; 12 months postpartum
Self-reported adherence to recommended postpartum care for chronic conditions (hypertension, diabetes, and mental health), including medication adherence and engagement with healthcare providers for condition management.
Measured at post-discharge (4-8 weeks); 6 months postpartum; 12 months postpartum

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.
University of Massachusetts, Worcester

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.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

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: Margaret McConnell, PhD, Harvard School of Public Health (HSPH)
  • Principal Investigator: Margaret Parker, MD, UMass Memorial Health

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.
October 24, 2024

Primary Completion (Estimated)

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 1, 2028

Study Completion (Estimated)

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.
August 31, 2028

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).
March 22, 2024

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.
April 10, 2024

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.
April 12, 2024

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.
January 8, 2026

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.
January 6, 2026

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.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

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.
  • Study00001150
  • 1R01HD109293-01 (U.S. NIH Grant/Contract)
  • 6-23FY-0012 (Other Grant/Funding Number: March of Dimes)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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