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Enrolling by Invitation

NCT Number: NCT07702318

Early Childhood (2-year) Outcomes Among Former VLBW From the ReDiMOM Trial

The goal of this study is to determine the long-term outcomes associated with an economic intervention that was provided to encourage mother's of very premature infants to provide mother's own milk. This study will follow children after they are discharged from the Neonatal Intensive Care Unit, where their mothers received the economic intervention, out to age 2 years. This study will examine childhood outcomes at 2 years of age based on which group the mothers had been randomized into. This study will also determine the relationship between the total duration mother's own milk was received during the first year of life and early childhood outcomes at age 2 years in infants that were born very premature.

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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

Up to 3 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

  • Completion of the ReDiMOM RCT
  • survival of infant to NICU discharge

Exclusion criteria

  • Mother has participated in this study with a previous pregnancy
  • infant is enrolled in another study that impacts neurodevelopment or adiposity
  • in the neonatologist's opinion the infant is unlikely to survive
  • the mother is unable or unwilling to provide consent

Treatment and study plan

Primary outcomes

  1. Cognition

    Time frame: 2 years

    Cognitive index scores on Bayley Scales of Infant and Toddler Development-4th Edition at 20 months CA.

  2. Adiposity

    Time frame: 2 years

    Adiposity measured by BIA

  3. MOM duration

    Time frame: 1 year

    Duration of partial and/or exclusive MOM feedings through the first year of life using questionnaire.

  4. Total costs

    Time frame: 2 years

    Total costs at 20 months CA will be determined from the societal perspective and defined as the sum of ReDiMOM intervention, healthcare, EI and associated family costs from birth to 20 months CA. Detailed intervention costs for each infant are already collected for the original ReDiMOM RCT. Healthcare costs will be obtained from 5 sources: 1) ReDiMOM RCT prospective database, 2) self-report questionnaire to assess family healthcare costs, 3) Medicaid claims, 4) Illinois State Early Intervention Database, and 5) RUMC system-wide cost-account and billing systems

  5. Language

    Time frame: 2 years

    Language index scores on Bayley Scales of Infant and Toddler Development-4th Edition at 20 months CA.

  6. Motor

    Time frame: 2 years

    Motor index scores on Bayley Scales of Infant and Toddler Development-4th Edition at 20 months CA.

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

Early Childhood Neurodevelopmental, Economic and Nutritional Outcomes Among Former Very Low Birth Weight Infants From the Reducing Disparity in Mother's Own Milk (ReDiMOM) Trial

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
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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