Viewing Study NCT00059540



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Last Modification Date: 2024-10-26 @ 9:08 AM
Study NCT ID: NCT00059540
Status: COMPLETED
Last Update Posted: 2016-09-21
First Post: 2003-04-28

Brief Title: The Maternal Lifestyle Study MLS
Sponsor: NICHD Neonatal Research Network
Organization: NICHD Neonatal Research Network

Study Overview

Official Title: The Maternal Lifestyle Study
Status: COMPLETED
Status Verified Date: 2016-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: MLS
Brief Summary: This is a longitudinal multi-site observational study of the long-term effects of a mothers use of cocaine andor opiates during pregnancy on her infant This observational study evaluates the medical developmental social environmental and neurobehavioral outcomes for 1400 of the original cohort of children A series of follow-up examinations of these children were conducted in 5 phases 1-36 months 35-7 years and 8-11 years Children are currently being examined at 13 years of age
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 andor 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 20000 infants were screened with a goal of enrolling 16000 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 1400 exposed and nonexposed infants with respect to long-term neurodevelopmental outcomes These infants were among the 16000 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 2000 exposed infants enrolled into Phase II and 1000 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
U10DA024128 NIH None httpsreporternihgovquickSearchU10DA024128
U10HD021397 NIH None None
U10HD021415 NIH None None
U10HD027904 NIH None None
U10HD021385 NIH None None
U10DA024117 NIH None None
U10DA024118 NIH None None
U10DA024119 NIH None None