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The Maternal Lifestyle Study (MLS)

NCT00059540 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 11811

Last updated 2016-09-21

No results posted yet for this study

Summary

This is a longitudinal, multi-site observational study of the long-term effects of a mother's use of cocaine and/or opiates during pregnancy on her infant. This observational study evaluates the medical, developmental, social, environmental, and neurobehavioral outcomes for 1,400 of the original cohort of children. A series of follow-up examinations of these children were conducted in 5 phases: 1-36 months, 3.5-7 years, and 8-11 years. Children are currently being examined at 13 years of age.

Conditions

  • Cocaine
  • Substance Abuse
  • Infant, Newborn
  • Pregnancy
  • Pregnant Women
  • Prenatal Care

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Children's Bureau - Administration for Children and Families

    collaborator OTHER

  • Substance Abuse and Mental Health Services Administration (SAMHSA)

    collaborator FED

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

    collaborator NIH

  • NICHD Neonatal Research Network

    lead NETWORK

Principal Investigators

  • Barry M. Lester, PhD · Brown University, Women & Infants Hospital of Rhode Island

  • Abhik Das, PhD · RTI International

  • Charles R. Bauer, MD · University of Miami

  • Henrietta S. Bada, MD · University of Tennessee

  • Seetha Shankaran, MD · Wayne State University

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
1993-05-31
Primary Completion
1995-03-31
Completion
2011-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00059540 on ClinicalTrials.gov