Grantee Research Project Results
2003 Progress Report: Neurobehavioral Effects of Prevalent Toxicants in Children
EPA Grant Number: R829389C001Subproject: this is subproject number 001 , established and managed by the Center Director under grant R829389
(EPA does not fund or establish subprojects; EPA awards and manages the overall grant for this center).
Center: CECEHDPR - University of Cincinnati Center for the Study of Prevalent Neurotoxicants in Children
Center Director: Lanphear, Bruce
Title: Neurobehavioral Effects of Prevalent Toxicants in Children
Investigators: Lanphear, Bruce , Bearer, Cynthia , Ris, Douglas , Khoury, Jane , Dietrich, Kim , Yolton, Kimberly , Hornung, Richard
Current Investigators: Lanphear, Bruce , Dietrich, Kim
Institution: Children Hospital of Cincinnati , Case Western Reserve University , University of Cincinnati
Current Institution: Children Hospital of Cincinnati , University of Cincinnati
EPA Project Officer: Hahn, Intaek
Project Period: November 1, 2001 through October 31, 2006
Project Period Covered by this Report: November 1, 2002 through October 31, 2003
RFA: Centers for Children's Environmental Health and Disease Prevention Research (2001) RFA Text | Recipients Lists
Research Category: Children's Health , Human Health
Objective:
The objective of this research project is to test the efficacy of an intervention for the primary prevention of lead toxicity, as measured by lead concentration and neurobehavioral functioning at 36 months of age. The control arm for the lead hazard reduction intervention has grown in scope to allow the evaluation of broader and more costly lead hazard controls and the addition of another physical housing-based intervention designed to reduce unintentional injury. We hypothesize that the installation of multiple passive measures in the households of index children, randomized to the intervention group, will reduce unintentional injury across residential mechanisms by 30 percent in the injury arm compared to the lead arm. We also have added a 4-week home visit to the protocol to collect breast milk from breastfeeding mothers and conduct a newborn behavioral evaluation.
Progress Summary:
Infrastructure
IRB/HIPAA. Institutional Review Board (IRB) and Health Insurance and Portability Accountability Act (HIPAA) approvals have been obtained and/or maintained for multiple institutions.
Specimens. A custom Internet-based system has been established for bar-coding and tracking all biologic and environmental samples. Samples are processed and stored at the Laboratory Core, headed by Sandy Roda. We already are reporting results of maternal blood lead tests to the state, participant women, and their obstetricians.
Study Tracking. This same Internet-based system was designed for our study to track all participant appointments and data collection points and is used for administration of electronic questionnaires (direct data entry).
Staffing. Several staff have been hired and trained to perform data collection, including four Interviewers, two Environmental Technicians, one Intervention Coordinator, and two Intervention Technicians.
Collaborations
In the past year, this study has built relationships needed for study success, including collaborations with four prenatal practices for recruitment, three hospitals for the collection of birth specimens, and the local Neonatal Research Network nurses, who participate actively in study recruitment and work with area hospitals.
The lead hazard reduction intervention has required working closely with Departments of Health from both Ohio and Kentucky. The intervention also has relied on consulting from the National Center for Healthy Housing for protocol development and has trained four groups of local lead hazard reduction contracting groups.
Recruitment
As of July 14, 2003, 741 pregnant women were prescreened for woman’s age and housing age, 445 were sent letters of invitation, 36 agreed to participate and completed the study consent, and 22 completed the baseline home visit.
Lead and Injury Intervention
All forms and protocols have been finalized for the lead hazard control intervention. Eighteen participants have entered the randomized controlled trial. Intensive inspection and lead evaluations have been completed for the first three families in the lead arm.
Increasing Enrollment
Two factors contributed to a slow rate of enrollment: (1) a late change in the protocol to include only women living in homes built prior to 1979 resulted in 19 percent of our potential sample being disqualified; and (2) because the study seeks to understand exposures in the home during early pregnancy and will modify the home during pregnancy, women are eligible only if they have not moved in the prior 3 months and have no plans to move before delivering. More women than anticipated were disqualified because of these reasons. We are reevaluating the latter eligibility criterion to enhance enrollment. Excluding this criterion will increase the number of eligible women by about 30 percent and, we estimate, double the number of women enrolled per month.
We also are working with additional prenatal practices to expand recruitment for the study. We have had a delay in obtaining a HIPAA Waiver of Individual Authorization from one of our participating hospitals (Mercy Hospital Anderson) and a consequent delay in partnering with other prenatal practices affiliated with this hospital. We have approached a fourth hospital that performs a large number of Cincinnati deliveries: the Good Samaritan Hospital. We hope to obtain IRB approval in the coming few months and then to invite at least two large prenatal practices delivering at this hospital, including clinic and private-practice groups.
Intervention Component (Supplement)
The intervention study was expanded to include a control arm for the evaluation of another housing-based intervention designed to reduce unintentional injury via passive environment modifications. The scope of the lead hazard controls also was increased substantially. The average cost of a lead hazard control is estimated now to be more than $4,000, with many costing as much as $10,000. We hypothesize that the installation of multiple, passive measures in the households of index children randomized to the intervention group will reduce unintentional injury across residential mechanisms by 30 percent in the injury arm compared to the lead arm.
Participant Status. As of July 14, 2003, 18 participants have been randomized, 10 are in the injury hazard control arm, 8 are in the lead hazard control arm, and 3 have completed lead intervention planning visits.
Lead Intervention. All forms and protocols for the lead hazard control intervention have been finalized. Extensive training has been completed with the Intervention Technician(s) and will continue throughout the year until all intervention staff are trained on lead hazard assessment and lead hazard control. To date, eight participants have been randomized to the lead hazard control arm. Three participants have completed intervention planning visits, and lead hazard control measures will be implemented in these participants’ homes in the upcoming weeks. William Menrath, who has extensive experience in risk assessment and lead hazard control, has agreed to assist us in designing the protocols, training our staff in risk assessment, and performing reliability assessments of our staff. Mr. Menrath’s efforts will replace some of the efforts we initially planned for the National Center for Healthy Housing, but the National Center still is involved actively in the protocol and training.
Injury Intervention. Forms and protocols for the injury hazard control intervention (i.e., the control arm) currently are under development and review. In-office staff training for the injury intervention arm has begun and will continue throughout the year. To date, 10 participants have been randomized into the injury hazard control arm.
Collaborations. The lead hazard control intervention has required working closely with the Departments of Health from both Ohio and Kentucky. The lead intervention also has relied on consulting from the National Center for Healthy Housing for protocol development, and has trained five groups of local lead hazard reduction contracting groups. The injury hazard control intervention has consulted with a local baby-proofing business for consulting, training, and purchasing of safety devices.
Future Activities:
The first study birth is expected in mid-August. Study and hospital staff are preparing for the collection of umbilical cord blood and meconium specimens. Identification of study moms who deliver and round-the-clock staffing will be critical aspects of these collections. Chart abstraction will be performed to assess key aspects of medical confounders around the time of birth, and outcomes of infant length, weight, and head circumference.
To evaluate exposure during the latter half of pregnancy and to assess outcomes earlier than 1 year of life, the study has added an additional home visit when the infant is 4 weeks of age. This visit will include: (1) research-quality measures of infant length, weight, and head circumference; (2) a maternal questionnaire to assess exposure to toxins; (3) breast milk collection; and (4) maternal hair collection.
Lead and Injury Intervention
Lead interventions will be complete for our first families in mid-July, prior to delivery. Injury intervention measures will be installed after the child has reached 3 months of age because children are not mobile before this time, and the installation of safety devices can increase trip hazards inadvertently for pregnant women. In the coming months, all injury forms and protocols will be finalized. The first injury intervention will take place this fall.
Outcomes Assessment
Infant length, weight, and head circumference will be obtained at birth and at 4 weeks of age later this summer. A subsample of babies will be administered an early test of infant reflexes, state response, and reactivity (the Neonatal Network Neurobehavioral Scale), both in the hospital after birth and at 4 weeks of age.
Injuries to the index child and any siblings will be assessed by telephone survey when the child is 3 months of age, beginning in late October.
Selection and extensive training of psychometricians will begin this winter to prepare us for the first administration of the Bayley Scales of Infant Development in the summer of 2004.
Lead interventions will be complete for our first families in mid-July, prior to delivery. Injury intervention planning visits are scheduled to begin after birth. Injury intervention measures will be installed after the child has reached 3 months of age because children are not mobile before this time, and the installation of safety devices, such as stair gates, inadvertently increases the risk of a fall for the pregnant woman. In the coming months, all injury forms and protocols will be finalized. Field training for Intervention Technicians will occur in the early fall (October – December 2003). The first injury intervention will occur in late fall/early winter.
Journal Articles:
No journal articles submitted with this report: View all 19 publications for this subprojectSupplemental Keywords:
toxicology, ADHD, behavioral assessment, behavioral deficit, genetic susceptibility, pesticides, biomarkers, environmental agents, exposure, exposure assessment, hearing loss, lead, meconium, neurotoxicity, pesticide exposure, risk assessment, toxicants, lead-based paint, lead hazard control,, RFA, Scientific Discipline, Health, ENVIRONMENTAL MANAGEMENT, Toxics, Toxicology, Health Risk Assessment, Chemistry, pesticides, Risk Assessments, Children's Health, Biology, Risk Assessment, pesticide exposure, behavioral assessment, lead, neurotoxicity, children, toxicity, behavioral deficits, biological markers, exposure assessmentRelevant Websites:
http://www.healthyhomestoday.com Exit
http://www.cincinnatichildrens.org/research/project/enviro Exit
Progress and Final Reports:
Original AbstractMain Center Abstract and Reports:
R829389 CECEHDPR - University of Cincinnati Center for the Study of Prevalent Neurotoxicants in Children Subprojects under this Center: (EPA does not fund or establish subprojects; EPA awards and manages the overall grant for this center).
R829389C001 Neurobehavioral Effects of Prevalent Toxicants in Children
R829389C002 Validation of Meconium Markers of Fetal Neurotoxicant Exposures
R829389C003 Community-Based Research Project Identifying Residential Hazards Using Home Test Kits
R829389C004 Early Exposure to Lead and Adult Antisocial Outcome
R829389C005 Magnetic Resonance Assessment of Brain Function Altered by Lead Exposure
The perspectives, information and conclusions conveyed in research project abstracts, progress reports, final reports, journal abstracts and journal publications convey the viewpoints of the principal investigator and may not represent the views and policies of ORD and EPA. Conclusions drawn by the principal investigators have not been reviewed by the Agency.
Project Research Results
Main Center: R829389
151 publications for this center
111 journal articles for this center