The Maternal Lifestyle Study (MLS)

Pregnancy Clinical Trial

— MLS  

Official title:

The Maternal Lifestyle Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00059540
• Other study ID #: NICHD-NRN-0008
• Secondary ID: U10HD021397U10HD
• Status: Completed
• Phase: Phase 4
• First received: April 28, 2003
• Last updated: September 20, 2016
• Start date: May 1993
• Est. completion date: March 2011

Study information

• Verified date: September 2016
• Source: NICHD Neonatal Research Network
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11811
• Est. completion date: March 2011
• Est. primary completion date: March 1995
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cocaine
• Infant, Newborn
• Pregnancy
• Pregnant Women
• Prenatal Care
• Substance Abuse
• Substance-Related Disorders

Locations

Country	Name	City	State
United States	Wayne State University	Detroit	Michigan
United States	RTI International	Durham	North Carolina
United States	University of Tennessee	Memphis	Tennessee
United States	University of Miami	Miami	Florida
United States	Brown University, Women & Infants Hospital of Rhode Island	Providence	Rhode Island

Sponsors (5)

Lead Sponsor	Collaborator
NICHD Neonatal Research Network	Administration for Children & Families (ACF), Eunice Kennedy Shriver Institute of Child Health and Human Development, National Institute on Drug Abuse (NIDA), Substance Abuse and Mental Health Services Administration (SAMHSA)

Country where clinical trial is conducted

United States, 

References & Publications (46)

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. — View Citation

Bada HS, Bann CM, Bauer CR, Shankaran S, Lester B, LaGasse L, Hammond J, Whitaker T, Das A, Tan S, Higgins R. Preadolescent behavior problems after prenatal cocaine exposure: Relationship between teacher and caretaker ratings (Maternal Lifestyle Study). N — View Citation

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. — View Citation

Bada HS, Bauer CR, Shankaran S, Lester B, Wright LL, Verter J, Smeriglio VL, Finnegan LP, Maza PL. Central and autonomic nervous systems' signs associated with in utero exposure to cocaine/opiates. Ann N Y Acad Sci. 1998 Jun 21;846:431-4. — View Citation

Bada HS, Das A, Bauer CR, Shankaran S, Lester B, LaGasse L, Hammond J, Wright LL, Higgins R. Impact of prenatal cocaine exposure on child behavior problems through school age. Pediatrics. 2007 Feb;119(2):e348-59. — View Citation

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. — View Citation

Bada HS, Das A, Bauer CR, Shankaran S, Lester BM, Gard CC, Wright LL, Lagasse L, Higgins R. Low birth weight and preterm births: etiologic fraction attributable to prenatal drug exposure. J Perinatol. 2005 Oct;25(10):631-7. — View Citation

Bada HS, Langer J, Twomey J, Bursi C, Lagasse L, Bauer CR, Shankaran S, Lester BM, Higgins R, Maza PL. Importance of stability of early living arrangements on behavior outcomes of children with and without prenatal drug exposure. J Dev Behav Pediatr. 2008 — View Citation

Bagner DM, Sheinkopf SJ, Miller-Loncar C, LaGasse LL, Lester BM, Liu J, Bauer CR, Shankaran S, Bada H, Das A. The effect of parenting stress on child behavior problems in high-risk children with prenatal drug exposure. Child Psychiatry Hum Dev. 2009 Mar;4 — View Citation

Bauer CR, Langer JC, Shankaran S, Bada HS, Lester B, Wright LL, Krause-Steinrauf H, Smeriglio VL, Finnegan LP, Maza PL, Verter J. Acute neonatal effects of cocaine exposure during pregnancy. Arch Pediatr Adolesc Med. 2005 Sep;159(9):824-34. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

ElSohly MA, Stanford DF, Murphy TP, Lester BM, Wright LL, Smeriglio VL, Verter J, Bauer CR, Shankaran S, Bada HS, Walls HC. Immunoassay and GC-MS procedures for the analysis of drugs of abuse in meconium. J Anal Toxicol. 1999 Oct;23(6):436-45. — View Citation

Gaskins RB, LaGasse LL, Liu J, Shankaran S, Lester BM, Bada HS, Bauer CR, Das A, Higgins RD, Roberts M. Small for gestational age and higher birth weight predict childhood obesity in preterm infants. Am J Perinatol. 2010 Oct;27(9):721-30. doi: 10.1055/s-0 — View Citation

Gauthier SM, Bauer CR, Messinger DS, Closius JM. The Bayley Scales of Infant Development. II: Where to start? J Dev Behav Pediatr. 1999 Apr;20(2):75-9. Erratum in: J Dev Behav Pediatr 1999 Jun;20(3):197. — View Citation

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. — View Citation

LaGasse LL, Van Vorst RF, Brunner SM, Lester BM. Effects of in utero exposure to cocaine and/or opiates on infants' reaching behavior. Ann N Y Acad Sci. 1998 Jun 21;846:405-7. — View Citation

Lester BM, Bagner DM, Liu J, LaGasse LL, Seifer R, Bauer CR, Shankaran S, Bada H, Higgins RD, Das A. Infant neurobehavioral dysregulation: behavior problems in children with prenatal substance exposure. Pediatrics. 2009 Nov;124(5):1355-62. doi: 10.1542/pe — View Citation

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. — View Citation

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. — View Citation

Lester BM, Lagasse LL, Shankaran S, Bada HS, Bauer CR, Lin R, Das A, Higgins R. Prenatal cocaine exposure related to cortisol stress reactivity in 11-year-old children. J Pediatr. 2010 Aug;157(2):288-295.e1. doi: 10.1016/j.jpeds.2010.02.039. Epub 2010 Apr — View Citation

Lester BM, Tronick EZ, Brazelton TB. The Neonatal Intensive Care Unit Network Neurobehavioral Scale procedures. Pediatrics. 2004 Mar;113(3 Pt 2):641-67. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Lester BM. The Maternal Lifestyles Study. Ann N Y Acad Sci. 1998 Jun 21;846:296-305. — View Citation

Levine TP, Liu J, Das A, Lester B, Lagasse L, Shankaran S, Bada HS, Bauer CR, Higgins R. Effects of prenatal cocaine exposure on special education in school-aged children. Pediatrics. 2008 Jul;122(1):e83-91. doi: 10.1542/peds.2007-2826. Epub 2008 Jun 9. — View Citation

Liu J, Bann C, Lester B, Tronick E, Das A, Lagasse L, Bauer C, Shankaran S, Bada H. Neonatal neurobehavior predicts medical and behavioral outcome. Pediatrics. 2010 Jan;125(1):e90-8. doi: 10.1542/peds.2009-0204. Epub 2009 Dec 7. — View Citation

Maza PL, Wright LL, Bauer CR, Shankaran S, Bada HS, Lester B, Krause-Steinrauf H, Smeriglio VL, Bowler A, Katsikiotis V. Maternal Lifestyles Study (MLS). Caretaking environment and stability of substance-exposed infants at one month corrected age. Ann N Y — View Citation

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. — View Citation

Miller-Loncar C, Lester BM, Seifer R, Lagasse LL, Bauer CR, Shankaran S, Bada HS, Wright LL, Smeriglio VL, Bigsby R, Liu J. Predictors of motor development in children prenatally exposed to cocaine. Neurotoxicol Teratol. 2005 Mar-Apr;27(2):213-20. Epub 20 — View Citation

Salisbury AL, Lester BM, Seifer R, Lagasse L, Bauer CR, Shankaran S, Bada H, Wright L, Liu J, Poole K. Prenatal cocaine use and maternal depression: effects on infant neurobehavior. Neurotoxicol Teratol. 2007 May-Jun;29(3):331-40. Epub 2006 Dec 14. Erratu — View Citation

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. — View Citation

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. — View Citation

Shankaran S, Das A, Bauer CR, Bada H, Lester B, Wright L, Higgins R, Poole K. Fetal origin of childhood disease: intrauterine growth restriction in term infants and risk for hypertension at 6 years of age. Arch Pediatr Adolesc Med. 2006 Sep;160(9):977-81. — View Citation

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. — View Citation

Shankaran S, Lester BM, Das A, Bauer CR, Bada HS, Lagasse L, Higgins R. Impact of maternal substance use during pregnancy on childhood outcome. Semin Fetal Neonatal Med. 2007 Apr;12(2):143-50. Epub 2007 Feb 20. Review. — View Citation

Sheinkopf SJ, Lagasse LL, Lester BM, Liu J, Seifer R, Bauer CR, Shankaran S, Bada H, Das A. Vagal tone as a resilience factor in children with prenatal cocaine exposure. Dev Psychopathol. 2007 Summer;19(3):649-73. — View Citation

Sheinkopf SJ, Lagasse LL, Lester BM, Liu J, Seifer R, Bauer CR, Shankaran S, Bada H, Higgins R, DAS A. Prenatal cocaine exposure: cardiorespiratory function and resilience. Ann N Y Acad Sci. 2006 Dec;1094:354-8. — View Citation

Sheinkopf SJ, Lester BM, LaGasse LL, Seifer R, Bauer CR, Shankaran S, Bada HS, Poole WK, Wright LL. Interactions between maternal characteristics and neonatal behavior in the prediction of parenting stress and perception of infant temperament. J Pediatr P — View Citation

Sheinkopf SJ, Lester BM, Sanes JN, Eliassen JC, Hutchison ER, Seifer R, Lagasse LL, Durston S, Casey BJ. Functional MRI and response inhibition in children exposed to cocaine in utero. Preliminary findings. Dev Neurosci. 2009;31(1-2):159-66. doi: 10.1159/ — View Citation

Stephens BE, Liu J, Lester B, Lagasse L, Shankaran S, Bada H, Bauer C, Das A, Higgins R. Neurobehavioral assessment predicts motor outcome in preterm infants. J Pediatr. 2010 Mar;156(3):366-71. doi: 10.1016/j.jpeds.2009.09.042. Epub 2009 Nov 1. — View Citation

Stone KC, High PC, Miller-Loncar CL, Lagasse LL, Lester BM. Longitudinal study of maternal report of sleep problems in children with prenatal exposure to cocaine and other drugs. Behav Sleep Med. 2009;7(4):196-207. doi: 10.1080/15402000903190108. — View Citation

Stone KC, LaGasse LL, Lester BM, Shankaran S, Bada HS, Bauer CR, Hammond JA. Sleep problems in children with prenatal substance exposure: the Maternal Lifestyle study. Arch Pediatr Adolesc Med. 2010 May;164(5):452-6. doi: 10.1001/archpediatrics.2010.52. — View Citation

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. — View Citation

* Note: There are 46 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neurodevelopmental impairment		1 month of age	No

External Links

•   Maternal Lifestyle Study description