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

April 28, 2003
January 9, 2011
May 1993
March 1995   (final data collection date for primary outcome measure)
Neurodevelopmental impairment [ Time Frame: 1 month of age ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00059540 on ClinicalTrials.gov Archive Site
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The Maternal Lifestyle Study (MLS)
The Maternal Lifestyle Study

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Mother and baby dyads delivered at the 4 participating centers.

  • Cocaine
  • Substance Abuse
  • Infant, Newborn
  • Pregnancy
  • Pregnant Women
  • Prenatal Care
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
11811
March 2011
March 1995   (final data collection date for primary outcome measure)

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
Both
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Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00059540
NICHD-NRN-0008, U10HD021397, U10HD021415, U10HD027904, U10HD021385, U10DA024117, U10DA024118, U10DA024119, U10DA024128
Yes
Barry M. Lester/ Lead Principal Investigator, Brown University, Women & Infants Hospital of Rhode Island
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Institute on Drug Abuse (NIDA)
  • Administration for Children & Families (ACF)
  • Substance Abuse and Mental Health Services Administration (SAMHSA)
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
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP