Grantee Research Project Results
2004 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, 2003 through October 31, 2004
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.
Progress Summary:
Recruitment, Enrollment, and Study Progress
As of June 7, 2004:
- 3,139 pregnant women were prescreened (age, gestational age, housing year built, county).
- 1,887 were sent letters of invitation.
- 1,740 completed the screening process (confirm year built, gestational age, plans to move out of study area, confounding medical conditions, interest in study).
- 466 were eligible for the study.
- 161 agreed to participate and completed the study consent.
- 140 completed the baseline home visit.
- 87 delivered their babies.
Phone questionnaires to assess injuries to the index child and any siblings, maternal supervision, and infant feeding and sleep patterns began in January 2004. The phone questionnaires are administered quarterly, starting when the child is 3 months of age.
Increasing Enrollment
Shortly after enrollment began in February 2003, two major factors were found to contribute to a delayed rate of enrollment. The first was the decision to include only women living in homes built prior to 1979. The second was the moving eligibility criteria (i.e., because the study seeks to understand exposures in the home during early pregnancy, and because we will modify the home during pregnancy, women were eligible only if they had not moved in the prior 3 months and had no plans to move before delivery). We reevaluated these two eligibility criteria and decided to drop the latter to enhance enrollment. As expected, removing the moving eligibility criterion resulted in a considerable increase in eligibility, from 21 percent to 29 percent of all women screened.
We also expanded our recruitment efforts by approaching four new prenatal practices and one hospital obstetrics (OB) clinic. Given our delayed rate of enrollment and difficulties in enrolling nonwhite participants, we approached large prenatal practices/clinics and practices/clinics that served African American women. Three of the five practices began recruiting participants last summer. One of the practices is a community-based health network that has three OB clinic sites in the greater Cincinnati area. These three clinics began recruiting women for the Health Outcomes and Measures of the Environment (HOME) Study in the fall of 2003. Subsequently, the percent of participants who are African American has increased, from 13 percent of the total participants to 24 percent of total participants. Our ultimate goal is to have approximately 160 (40%) African American families participating in the study.
To begin recruitment from the Good Samaritan Hospital OB Clinic (GS OB Clinic), we had to approach a new Institutional Review Board (IRB), TriHealth IRB, and wait for its approval of study protocol and procedures. We recently received final IRB (June 15, 2004) approval from TriHealth. We will begin recruitment from the GS OB Clinic in July. We expect that the addition of the GS OB Clinic will allow us to enroll three to five more participants per month. At this rate (approximately 18 participants/month), we would expect to complete enrollment by the summer of 2005. If we are not able to enroll at this rate with the GS OB Clinic, we may approach other prenatal practices that deliver at Good Samaritan Hospital.
Infrastructure
IRB/HIPAA. IRB and Health Insurance and Portability Accountability Act (HIPAA) approvals have been obtained recently from TriHealth and maintained for Cincinnati Children’s Hospital Medical Center (CCHMC), University of Cincinnati, Christ Hospital, and the Centers for Disease Control and Prevention (CDC). IRB and HIPAA approvals were not renewed for Mercy Anderson Hospital (see “Collaborations” section below).
Selection of psychometricians was completed in March 2004. Extensive training of psychometricians for the administration of the Bayley Scales of Infant Development and the Wechsler Abbreviated Scale of Intelligence is ongoing.
Collaborations
In the past year, this study has maintained its collaborations with all of the prenatal practices originally approached for recruiting, with the exception of Mercy Anderson Hospital. Mercy Anderson Hospital’s Internal IRB dissolved in July 2003. For ongoing studies, Mercy Anderson Hospital asked the lead institution to accept a deferral of IRB approval. Given the complexities of this arrangement, the substantial time it would take to finalize a legal agreement between CCHMC and Mercy Anderson Hospital, and the small pool of patients that the Mercy Anderson OB Clinic had for potential recruitment, we decided to discontinue our recruitment through Mercy Anderson Hospital.
We have maintained our collaboration with the National Institute of Child Health and Human Development-funded Neonatal Research Network nurses. They currently work on recruitment and enrollment through the University Hospital OB Clinic; attend to births at all participating hospitals; and will assist with recruitment, enrollment, and births at Good Samaritan Hospital starting in July 2004.
We also have built relationships with the Alliance Lab Services, part of The Health Alliance organization, to be able to use their laboratories throughout the greater Cincinnati area. We have conducted training on study sample collection methods at six Alliance Lab sites and will be conducting training at two additional laboratories in July 2004.
Lead and Injury Intervention
See the section below entitled: “Project 1: Intervention Component (Supplement).”
Study Visits and Outcome Assessments
The first 12-month home and clinic visits began in late July 2004. Study staff members are collecting blood, urine, and hair from the 12-month-old participants at the clinic visit. Outcome assessments taking place at the clinic visit include growth measures (length, weight, and head circumference) and developmental assessment (Bayley Scales of Infant Development). Maternal intelligence also is being measured as a covariate at the 12-month clinic visit (Weschler Abbreviated Scales of Intelligence).
The 12-month home visit includes the maternal questionnaire to assess the child’s exposure to toxins, the HOME Inventory, observational assessments of lead and injury hazards, and the collection of environmental samples.
Recruitment of participants through TriHealth’s Good Samaritan Hospital began in July 2004.
Sample Analyses
Samples collected to date from the first 50 participants who delivered their babies were sent to the CDC in June 2004 to begin analyses. Samples sent included maternal blood, serum, hair, saliva, cord blood, and meconium. We will use these samples to conduct preliminary tests for the correlations of various biomarkers.
Project 1: Intervention Component (Supplement)
Intervention Status. As of June 7, 2004:
- 126 participants have been randomized.
- 63 are in the lead hazard control arm (intervention takes place during pregnancy).
- 57 lead intervention planning visits have been completed.
- 39 lead hazard control interventions have been completed.
- The average cost of lead hazard control interventions is $5,284.93.
- 63 are in the injury hazard control arm (intervention takes place when child is ~ 4 months).
- 13 injury intervention planning visits have been completed.
- 12 injury hazard control interventions have been completed.
- The average cost of injury hazard control interventions is $249.32.
Lead Intervention. Lead intervention planning visits and interventions have been ongoing since June 2003.
Injury Intervention. All forms and protocols for the injury hazard control intervention were finalized. Extensive training for Intervention Technicians on injury hazard assessment and installation of safety products was conducted in conjunction with a child safety expert (Mark Movish, Baby-B-Safe, Inc.).
Injury intervention planning visits and interventions began in March 2004.
Collaborations. Existing regulations surrounding lead hazard control renovations require us to work closely with the departments of health (regulating agency). The Ohio Department of Health was able to accommodate the HOME Study’s objectives within its established regulations.
We also have continued our collaboration with the National Center for Healthy Housing (NCHH). The NCHH has conducted two site visits, one in September 2003 and one in January 2004. During the site visits, NCHH reviews intervention records, observes ongoing interventions in participants’ homes, and provides feedback to the intervention team regarding protocol adherence, research documentation, and lead-safe work methods.
For the Injury Hazard Control arm, we have continued our collaboration with a local child safety expert, Mark Movish. We consulted with Mr. Movish during the protocol and field form development phase of the project. He has been involved in the field training of Intervention Technicians and continues to serve as a resource for updates on safety products, ordering of safety products, and monitoring injury interventions for quality assurance purposes.
Future Activities:
We will continue to recruit participants through TriHealth’s Good Samaritan Hospital.
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,, 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