Clinical trialNCT00059540CompletedObservational

The Maternal Lifestyle Study (MLS)

SponsorNICHD Neonatal Research NetworkEnrollment11,811CocaineInfant, NewbornPregnancyPregnant WomenPrenatal CareSubstance Abuse

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Abhik Das, PhD
RTI International
Principal Investigator
clinicaltrials.gov ↗
Barry M. Lester, PhD
Brown University, Women & Infants Hospital of Rhode Island
Principal Investigator
clinicaltrials.gov ↗
Charles R. Bauer, MD
University of Miami
Principal Investigator
clinicaltrials.gov ↗
Henrietta S. Bada, MD
University of Tennessee
Principal Investigator
clinicaltrials.gov ↗
Seetha Shankaran, MD
Wayne State University
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

5 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

University of Miami
Miami, Florida, United States
Wayne State University
Detroit, Michigan, United States
Rti International
Durham, North Carolina, United States
Brown University, Women & Infants Hospital of Rhode Island
Providence, Rhode Island, United States
University of Tennessee
Memphis, Tennessee, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 31 May 1993
Primary completion: 31 Mar 1995
Completion: 31 Mar 2011
Last update posted: 21 Sept 2016
Registered enrollment: 11,811
Registry id: NCT00059540

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 4 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.