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Home > "T" Clinical Trials Conditions > The Maternal Lifestyle Study (MLS)  The Maternal Lifestyle Study (MLS)
The Maternal Lifestyle Study (MLS)
For Condition: Cocaine Abuse,Opiate Dependence,Cocaine Dependence
Status: No longer recruiting
Sponsor(s): National Institute of Child Health and Human Development (NICHD) , National Institute on Drug Abuse (NIDA)
Synopsis: This study will evaluate the effects of a mother’s use of cocaine and opiates during pregnancy on her infant. The study will assess both the short-term complications and the long-term outcomes.
Details: 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 Network of Neonatal Intensive Care Units, this study will evaluate the relationship between the mother’s use of cocaine and/or opiates during pregnancy and the effects on her infant. 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, nonlife 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, neurodendocrine function, and health disorders. Seventy-one percent of the original sample is still enrolled.
Eligibility:
Study Type: Observational, Psychosocial, Longitudinal, Case Control, Prospective Study
Minimum Age/Maximum Age: 16 Years/
Genders: Female
Protocol Entry Criteria: Inclusion Criteria for Mothers: - 18 years or older - Live near a study site Inclusion Criteria for Infants: - Birthweight greater than 500 grams (1.1 lbs) - Gestational age less than 43 weeks - Single or twin gestation
Total Enrollment: 16000
Location and Contact Information:
Overall Study Official:
BarryLester, Principal Investigator, Brown University
Women and Infants Hospital
Providence, Rhode Island, 02903
United States
University of Miami
Miami, Florida, 33101
United States
University of Tennessee
Memphis, Tennessee, 38163
United States
Wayne State University
Detroit, Michigan, 48201
United States
Additional Information:
Study ID Numbers: NICHD-1009; U10 HD21415,U10 HD21385,U10 HD27904,U10 HD21397
Study Start Date: May 1993
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00059540
Other Cocaine Abuse Studies:
1. The Maternal Lifestyle Study (MLS)
2. Determine the safety of a sublingual tablet formulation of buprenorphine and naloxone by extending the combination tablet availability to physicians in office-based practice
Related Studies:
Other Cocaine Abuse Clinical Trials
Other Florida Clinical Trials
Other Miami Clinical Trials
The Maternal Lifestyle Study (MLS)
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