The Maternal Lifestyle Study (MLS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Administration for Children & Families (ACF)
Substance Abuse and Mental Health Services Administration (SAMHSA)
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00059540
First received: April 28, 2003
Last updated: January 9, 2011
Last verified: September 2010
  Purpose

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.


Condition Phase
Cocaine
Substance Abuse
Infant, Newborn
Pregnancy
Pregnant Women
Prenatal Care
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Maternal Lifestyle Study

Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • Neurodevelopmental impairment [ Time Frame: 1 month of age ] [ Designated as safety issue: No ]

Enrollment: 11811
Study Start Date: May 1993
Estimated Study Completion Date: March 2011
Primary Completion Date: March 1995 (Final data collection date for primary outcome measure)
Detailed Description:

Interest in and availability of cocaine, marijuana, and opiates have complicated long-term investigations into the effects of the widespread recreational use of easily accessible substances like alcohol and tobacco. It remains impossible to determine in single site, small number studies what effects may be related to the use of a specific drug. By accessing the large multi-site population of newborn infants and their mothers available in the NICHD Neonatal Research Network, this study is evaluating the short- and long-term effects of mothers' cocaine and/or opiate use during pregnancy on their term or preterm infants.

Maternal practices assessed in this study include the use and abuse of opiates, cocaine, alcohol, marijuana, and nicotine. This study will address acute perinatal events and long-term medical, developmental, social, environmental, and neurobehavioral outcomes of infants whose mothers engaged in these maternal practices. The study will determine whether specific acute and long-term effects can be attributed to the use and abuse of specific substances.

Over 2 years, approximately 20,000 infants were screened with a goal of enrolling 16,000 infants. It was estimated that approximately 20% of infants would have been exposed to cocaine or opiates. The determination of exposure was based on self-report by the mother or positive meconium assay.

The first phase of the study evaluated the acute effects of maternal practices on infants. This phase involved all mothers who agreed to respond to the initial questionnaire and who allowed the meconium drug screen to be performed on their infants. Acute outcomes are being compared between infants who were exposed to cocaine and opiates through their mothers' use (the exposed group) and infants who were not exposed (the nonexposed group). Acute outcomes include abruptio placenta, fetal growth retardation, non-life threatening congenital malformations, respiratory distress syndrome, chronic lung disease, periventricular-intraventricular hemorrhage, necrotizing enterocolitis, retinopathy of prematurity, and periventricular leukomalacia.

The second phase of the study compared 1,400 exposed and nonexposed infants with respect to long-term neurodevelopmental outcomes. These infants were among the 16,000 infants enrolled in Phase I. It was estimated that 70% of the screened population would consent to participate in Phase II of the study, and 50% of these participants would complete all visits over the initial 3-year study period (2,000 exposed infants enrolled into Phase II and 1,000 exposed infants would complete all follow-up visits). For each exposed infant, an infant of similar age, race, sex, and either alcohol history or maternal age was selected from the nonexposed, screened population. All infants had physical, neurological, gestational age, and growth assessments at birth. The exposed and nonexposed infants were examined at 1, 4, 7, 9, 12, 18, 24, and 36 months corrected age. Follow-up assessments include medical history, and developmental, behavioral, social, and environmental outcomes.

The third phase of the study compared children at ages 4 to 7. The fourth phase is now comparing outcomes in children ages 8 to 11 years old. Assessments include measures of cognition, school performance, antisocial behavior, onset of substance use, psychopathology, neuroendocrine function, and health disorders. Seventy-one percent of the original sample is still enrolled.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Mother and baby dyads delivered at the 4 participating centers.

Criteria

Inclusion Criteria for Mothers:

  • 18 years or older
  • Live near a study site

Exclusion Criteria for Mothers:

  • Identified psychosis or history of institutionalization for retardation or emotional problems
  • Language barriers that prevented her from giving informed consent or understanding the study

Inclusion Criteria for Infants:

  • Inborn infants
  • Birthweight >501 grams (1.1 lbs)

Exclusion Criteria for Infants:

  • One of a multiple gestation
  • Gestational age >42 weeks
  • Viability of the infant
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00059540

Locations
United States, Florida
University of Miami
Miami, Florida, United States, 33136
United States, Michigan
Wayne State University
Detroit, Michigan, United States, 48201
United States, North Carolina
RTI International
Durham, North Carolina, United States, 27705
United States, Rhode Island
Brown University, Women & Infants Hospital of Rhode Island
Providence, Rhode Island, United States, 02905
United States, Tennessee
University of Tennessee
Memphis, Tennessee, United States, 38163
Sponsors and Collaborators
Administration for Children & Families (ACF)
Substance Abuse and Mental Health Services Administration (SAMHSA)
Investigators
Principal Investigator: Barry M. Lester, PhD Brown University, Women & Infants Hospital of Rhode Island
Principal Investigator: Abhik Das, PhD RTI International
Principal Investigator: Charles R. Bauer, MD University of Miami
Principal Investigator: Henrietta S. Bada, MD University of Tennessee
Principal Investigator: Seetha Shankaran, MD Wayne State University
  More Information

Additional Information:
Publications:

Responsible Party: Barry M. Lester/ Lead Principal Investigator, Brown University, Women & Infants Hospital of Rhode Island
ClinicalTrials.gov Identifier: NCT00059540     History of Changes
Other Study ID Numbers: NICHD-NRN-0008, U10HD021397, U10HD021415, U10HD027904, U10HD021385, U10DA024117, U10DA024118, U10DA024119, U10DA024128
Study First Received: April 28, 2003
Last Updated: January 9, 2011
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
NICHD Neonatal Research Network
Maternal Lifestyle Study
Cocaine abuse
Cocaine dependence
Opiate abuse
Opiate dependence
Follow-up
Neurodevelopmental outcome
Substance-related disorders

Additional relevant MeSH terms:
Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 29, 2014