CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 11,811 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00059540
NCT00059540N/ACompleted
CompareCT.gov

The Maternal Lifestyle Study

NICHD Neonatal Research Network·observational·Posted Apr 29, 2003·Updated Sep 21, 2016

In Brief

An observational study for Cocaine and 5 related conditions. Completed, enrolled 11,811 participants across 5 sites.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsCocaine, Substance Abuse, Infant, Newborn, Pregnancy, Pregnant Women, Prenatal Care
CountriesUnited States
CollaboratorsNational Institute on Drug Abuse (NIDA), Children's Bureau - Administration for Children and Families, Substance Abuse and Mental Health Services Administration (SAMHSA), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Timeline

N/ACompletedFinished
19931994199519961997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 29, 2003
Enrollment StartMay 1, 1993
Primary CompletionMar 1, 1995
Study CompletionMar 1, 2011
TodayJul 1, 2026
Enrollment to primary: 1.8 yearsPosted 23.2 years ago