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CompletedNo phase

Child Healthcare at MATER - Pediatric Study

Key facts

Who runs it
Thomas Jefferson University
Where
Philadelphia, United StatesSee the site
Trial code
Status
Completed
People taking part
49 people enrolled
Started
31 Dec 2021
Ended
29 Jan 2026
Type of study
Interventional, 2 groupsOne group gets no study treatment, for comparison.
Treatments tested
  • Group well child care
Record updated
23 April 2026

Who can take part

Age
18 years and older
Sex
Women only
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 10 criteriaShow less

Who can take part

  • at least 28 weeks pregnant or less than 2 weeks postpartum
  • receiving treatment for opioid use disorder
  • ability to read and speak English
  • plans to parent infant after delivery
  • intent to seek pediatric care within Nemours/Thomas Jefferson University system
  • intent to remain in the Philadelphia area for the next 2 years

Who cannot take part

  • plans to seek pediatric care outside of the Nemours/Thomas Jefferson University System; Following a live birth, participants will remain eligible to continue in the study unless the mother or infant experiences the following: gestational age at time of delivery less than or equal to 32 weeks or illness or clinical complication warranting prolonged hospitalization after delivery
  • inability to speak English
  • plans to move outside of the Philadelphia area in the next 2 years
  • plans to not parent infant after delivery

Where in United States

  • Thomas Jefferson UniversityPhiladelphia, United States

About the trial

What the trial wants to find out

The objective of this project is to implement and evaluate a group model of well child care for mothers in treatment for opioid use disorder and their children that addresses the specific health needs and concerns of opioid-exposed infants, is trauma informed, and is embedded within a maternal opioid use disorder treatment program. 108 mother-infant dyads will be randomized 1:1 to group well child care or individual well child care, and followed over an 18 month period. Qualitative and quantitative data will be collected at multiple time points. The efficacy of group well child care to improve health and healthcare-related outcomes will be evaluated.

The 2 groups in the trial

  • Individual well child careNo study treatment, for comparison

    Individuals randomized to the control arm will receive routine individualized well child care after birth hospital discharge.

  • Group well child careTreatment being tested

    Individuals randomized to the intervention arm will participate in group well child care after birth hospital discharge.

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Well Child Care Intervention for Infants of Mothers in Treatment for Opioid Use Disorder
Publications
Record updated
23 April 2026