Not Signed In -
Drug Abuse |
Hallucinogens; Methadone; Narcotics; PCP (Phencyclidine) |
Clinical Trial: The Maternal Lifestyle Study (MLS)
This study is no longer recruiting patients.
|
Purpose
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.
| Condition | Phase |
|---|---|
| Cocaine Abuse Cocaine Dependence Opiate Dependence | Phase IV |
MedlinePlus related topics: Cocaine Abuse; Drug Abuse
Study Type: Observational
Study Design: Psychosocial, Longitudinal, Case Control, Prospective Study
Official Title: The Maternal Lifestyle Study
Expected Total Enrollment: 16000
Study start: May 1993
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, neuroendocrine function, and health disorders. Seventy-one percent of the original sample is still enrolled.
Eligibility
Ages Eligible for Study: 16 Years and above, Genders Eligible for Study: Female
Accepts Healthy Volunteers
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
Location Information
Florida
University of Miami, Miami, Florida, 33101, United States
Michigan
Wayne State University, Detroit, Michigan, 48201, United States
Rhode Island
Women and Infants Hospital, Providence, Rhode Island, 02903, United States
Tennessee
University of Tennessee, Memphis, Tennessee, 38163, United States
Barry Lester, MD, Principal Investigator, Brown University
More Information
Click here for more information on the NICHD Neonatal Research Network.
Click here for more information on NICHD clinical trials.
Click here for more information on the Infant Development Center at Women and Infants Hospital.
Publications
Lester BM, ElSohly M, Wright LL, Smeriglio VL, Verter J, Bauer CR, Shankaran S, Bada HS, Walls HH, Huestis MA, Finnegan LP, Maza PL. The Maternal Lifestyle Study: drug use by meconium toxicology and maternal self-report. Pediatrics. 2001 Feb;107(2):309-17.
Andreozzi L, Flanagan P, Seifer R, Brunner S, Lester B. Attachment classifications among 18-month-old children of adolescent mothers. Arch Pediatr Adolesc Med. 2002 Jan;156(1):20-6.
Bada HS, Bauer CR, Shankaran S, Lester B, Wright LL, Das A, Poole K, Smeriglio VL, Finnegan LP, Maza PL. Central and autonomic system signs with in utero drug exposure. Arch Dis Child Fetal Neonatal Ed. 2002 Sep;87(2):F106-12.
Bada HS, Das A, Bauer CR, Shankaran S, Lester B, Wright LL, Verter J, Smeriglio VL, Finnegan LP, Maza PL. Gestational cocaine exposure and intrauterine growth: maternal lifestyle study. Obstet Gynecol. 2002 Nov;100(5 Pt 1):916-24.
Bauer CR, Shankaran S, Bada HS, Lester B, Wright LL, Krause-Steinrauf H, Smeriglio VL, Finnegan LP, Maza PL, Verter J. The Maternal Lifestyle Study: drug exposure during pregnancy and short-term maternal outcomes. Am J Obstet Gynecol. 2002 Mar;186(3):487-95.
LaGasse LL, Messinger D, Lester BM, Seifer R, Tronick EZ, Bauer CR, Shankaran S, Bada HS, Wright LL, Smeriglio VL, Finnegan LP, Maza PL, Liu J. Prenatal drug exposure and maternal and infant feeding behaviour. Arch Dis Child Fetal Neonatal Ed. 2003 Sep;88(5):F391-9.
Tronick EZ, Olson K, Rosenberg R, Bohne L, Lu J, Lester BM. Normative neurobehavioral performance of healthy infants on the Neonatal Intensive Care Unit Network Neurobehavioral Scale. Pediatrics. 2004 Mar;113(3 Pt 2):676-8.
Lester BM, Tronick EZ, LaGasse L, Seifer R, Bauer CR, Shankaran S, Bada HS, Wright LL, Smeriglio VL, Lu J. Summary statistics of neonatal intensive care unit network neurobehavioral scale scores from the maternal lifestyle study: a quasinormative sample. Pediatrics. 2004 Mar;113(3 Pt 2):668-75.
Lester BM, Tronick EZ, Brazelton TB. The Neonatal Intensive Care Unit Network Neurobehavioral Scale procedures. Pediatrics. 2004 Mar;113(3 Pt 2):641-67.
Lester BM, Tronick EZ. History and description of the Neonatal Intensive Care Unit Network Neurobehavioral Scale. Pediatrics. 2004 Mar;113(3 Pt 2):634-40.
Lester BM, Tronick EZ, LaGasse L, Seifer R, Bauer CR, Shankaran S, Bada HS, Wright LL, Smeriglio VL, Lu J, Finnegan LP, Maza PL. The maternal lifestyle study: effects of substance exposure during pregnancy on neurodevelopmental outcome in 1-month-old infants. Pediatrics. 2002 Dec;110(6):1182-92.
Lester BM, Lagasse L, Seifer R, Tronick EZ, Bauer CR, Shankaran S, Bada HS, Wright LL, Smeriglio VL, Liu J, Finnegan LP, Maza PL. The Maternal Lifestyle Study (MLS): effects of prenatal cocaine and/or opiate exposure on auditory brain response at one month. J Pediatr. 2003 Mar;142(3):279-85.
Messinger DS, Bauer CR, Das A, Seifer R, Lester BM, Lagasse LL, Wright LL, Shankaran S, Bada HS, Smeriglio VL, Langer JC, Beeghly M, Poole WK. The maternal lifestyle study: cognitive, motor, and behavioral outcomes of cocaine-exposed and opiate-exposed infants through three years of age. Pediatrics. 2004 Jun;113(6):1677-85.
Seifer R, LaGasse LL, Lester B, Bauer CR, Shankaran S, Bada HS, Wright LL, Smeriglio VL, Liu J. Attachment status in children prenatally exposed to cocaine and other substances. Child Dev. 2004 May-Jun;75(3):850-68.
Shankaran S, Das A, Bauer CR, Bada HS, Lester B, Wright LL, Smeriglio V. Association between patterns of maternal substance use and infant birth weight, length, and head circumference. Pediatrics. 2004 Aug;114(2):e226-34.
Shankaran S, Bauer CR, Bada HS, Lester B, Wright LL, Das A. Health-care utilization among mothers and infants following cocaine exposure. J Perinatol. 2003 Jul-Aug;23(5):361-7.
Das A, Poole WK, Bada HS. A repeated measures approach for simultaneous modeling of multiple neurobehavioral outcomes in newborns exposed to cocaine in utero. Am J Epidemiol. 2004 May 1;159(9):891-9.
Boukydis CF, Bigsby R, Lester BM. Clinical use of the Neonatal Intensive Care Unit Network Neurobehavioral Scale. Pediatrics. 2004 Mar;113(3 Pt 2):679-89.
Record last reviewed: December 2004
Last Updated: December 8, 2004
Record first received: April 28, 2003
ClinicalTrials.gov Identifier: NCT00059540
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- Addictions: An Overview (Cleveland Clinic)
- Adolescent Treatment Programs Reduce Drug Abuse, Produce Other Improvements (National Institute on Drug Abuse)
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