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OpenTrials
Enrolling by Invitation

NCT Number: NCT07702357

Preschool Outcomes of a Previous RCT - ReDiMOM (NCT04540575)

This study will evaluate neurodevelopmental, health, and economic outcomes in preschool children born very preterm that participated in a randomized trial of an economic intervention designed to increase breastmilk feedings while they were in the neonatal intensive care unit.

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Key information

Conditions

Preterm Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

2 year–6 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Rush University

Chicago, Illinois, 60612, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Child was enrolled in ReDiMOM Child is alive

Exclusion criteria

Child is not alive

Treatment and study plan

This is a an observational prospective cohort study of a previous interventional trial (NCT04540575)

Other

This is a an observational prospective cohort study

Primary outcomes

  1. Cognition

    Time frame: At 5-6 years of age

    Cognitive outcome tested by the Wechsler Preschool and Primary Scale of Intelligence

  2. Societal costs

    Time frame: Through 6 years of age

    Societal costs will be defined as the sum of healthcare, education, family, and ReDiMOM intervention costs from birth to ages 6 years of age. Data will be obtained from ReDiMOM RCT intervention costs (ReDiMOM study database), healthcare costs (Rush data warehouse), early intervention therapies, Medicaid claims, and family costs (questionnaires).

Secondary outcomes

  1. Behavior

    Time frame: Through 6 years of age

    Behavior will be evaluated with the Behavioral Assessment System for Children-Third Edition (BASC-3)

  2. Executive functioning

    Time frame: Through 6 years of age

    Executive functioning will be evaluated with the Behavioral Assessment System for Children-Third Edition (BASC-3)

  3. Growth

    Time frame: Through 6 years of age

    Anthropometric measurements taken annually

  4. Health-related quality of life

    Time frame: Through 6 years of age

    Health-related quality of life will be measured via the EQ-5D-Y

  5. Adiposity

    Time frame: Through 6 years of age

    Adiposity will be measured annually using Bioelectrical Impedance Analysis (BIA)

  6. Blood pressure

    Time frame: Through 6 years of age

    Measured annually

  7. Respiratory Health

    Time frame: Through 6 years of age

    History of recurrent wheeze or asthma will be collected via questionnaires

  8. Motor function

    Time frame: Through 6 years of age

    Motor function will be assessed with the Movement Assessment Battery for Children, Third Edition (MABC-3)

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Collaborators

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

Registry information

Official study title

Neurodevelopmental, Health, and Economic Outcomes at Preschool Age in Former Very Preterm Infants Randomized to An Economic Intervention to Support Mother's Own Milk

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Jul 14, 2026
Registry last updated
Jul 14, 2026

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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