Environmental ExposuresNCT00129324
HOME Study (Health Outcomes and Measures of the Environment Study)
A study of Environmental Exposures and Child Development, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in United States.
Trial summary
The goal of the HOME Study is to quantify the impact of low-level fetal and early childhood exposures to environmental toxicants including lead, mercury, and other metals, pesticides, polychlorinated biphenyls (PCBs), persistent organic pollutants (PBDEs/PFCs), phthalates, phenols, environmental tobacco smoke, and… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Environmental Exposures, Child Development, Lead and Injury Reduction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 468 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2003to Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pregnancy
- Participating prenatal practice/clinic
- Participating hospital
Who cannot join
- Residence outside study area
- Plans to move outside study area within 1 year
- Home built after 1978
- Less than 18 years of age
- Beyond 19 weeks of gestation
- Diagnosis of diabetes
Show all 12Show fewer
- Diagnosis of seizure disorder (taking anti-seizure medication)
- Diagnosis of thyroid disorder
- Diagnosis of AIDS or positive HIV test
- Diagnosis of bipolar disorder
- Diagnosis of schizophrenia
- Diagnosis of cancer resulting in radiation treatment or chemotherapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Environmental Health Center
Cincinnati, Ohio, 45229
About this study
Official title: Neurobehavioral Effects of Prevalent Neurotoxicants in Children: A Cohort Study of the Cincinnati Center for Children's Environmental Health
The goal of the HOME Study is to quantify the impact of low-level fetal and early childhood exposures to environmental toxicants including lead, mercury, and other metals, pesticides, polychlorinated biphenyls (PCBs), persistent organic pollutants (PBDEs/PFCs), phthalates, phenols, environmental tobacco smoke, and alcohol on child development, neurobehavior, health, and growth. The HOME Study will also evaluate meconium as a biomarker for fetal exposure and test the effectiveness of home repairs to control lead hazards and injuries in early childhood.
Read the detailed description
This study aims to examine the effects of low-level exposures to prevalent neurotoxicants on health, growth, and neurobehavior among a representative sample of children. Pregnant women were enrolled in the project around 16 weeks of gestation. In the first phase of the study, we followed children resulting from the pregnancy through the age of 36 months. The second phase extended follow-up through 72 months. Phase 3 extended follow-up to 8 years (range 7.5-10) with comprehensive neurobehavioral assessments. Phase 4 will allow follow-up at 12 years (range 11-13), and includes measures of health, growth and body composition, behavior and mental health, and neuroimaging. To address the potential adverse health risks of environmental chemicals, including persistent pollutants such as PBDEs and PFCs and other non-persistent chemicals, on fetal, infant, and child neurobehavior, the investigators are systematically examining their associations with endocrine function, cognition, learning and memory, motor skills, attention and executive function, and behavior from age 1 to 7.5-10 years. The investigators are also examining exposures at different developmental stages (in utero at 16 weeks of gestation, early childhood, school age, preadolescence) using stored biological samples and measure child neurobehavior at 1, 2, 3, 4, 5, 8, and 12 years. This longitudinal study will allow the investigators to determine the dose response, windows of susceptibility, and persistence of the association. The investigators are also examining the contribution of PBDE exposures from house dust in a subset of children who have complete sets of samples of maternal serum and child serum collected from annual visits along with extensive measures of mouthing behaviors.
Hypotheses from the four phases of the study are as follows:
- In utero exposures measured by survey (alcohol and ETS), maternal and cord blood (lead and mercury) maternal and cord serum (ETS), and urine (pesticides) are less predictive of in utero effects of prevalent toxicants, including cognition, behavior problems, and growth compared with the same toxicants in meconium.
- Prenatal and postnatal exposures to prevalent pesticides and ETS are associated with adverse neurobehavioral effects, and growth delay in children.
- Higher lead exposure, measured during pregnancy and early childhood using maternal blood, cord blood, meconium and children's blood, will be associated with lower IQ scores and more behavioral problems for children with a maximal blood lead level < 5 mg/dL.
- Children in the lead treatment arm will have: blood lead that is 2.7 mg/dL lower, higher IQ scores, greater growth velocity, and fewer behavioral problems than children in the control group.
- Levels of lead in dust, soil and water will be significantly lower for housing units in the lead treatment arm compared with the injury control arm at 36 and 48 month home visits.
- A multifactorial, housing intervention will reduce residential injury by 30 percent among children in the injury treatment arm compared with those in the lead treatment arm.
- Prenatal and Postnatal exposures to PBDEs and PFCs are associated with altered thyroid hormone levels and deficits in infant and child neurobehavior
- With increasing child age, PBDE exposure from household dust becomes a stronger predictor of child serum PBDE concentration than exposure from placenta or breast milk.
- Developmental PBDE and PFC exposures are associated with internalizing symptoms.
- Developmental PBDE and PFC exposures are associated with adverse changes in anatomical structure, neurochemistry, organization of white matter tracts, and connectivity of neural networks.
- PFAS affect the gene expression and function of several biological pathways that program the fetus/infant towards a 'thrifty phenotype'. This leads to accelerated early childhood growth, increased fat mass, and features of metabolic syndrome.
- Being tested
- Lead Hazard Control Intervention, Injury Hazard Control Intervention
- Keywords
- HOME, Environmental Exposure, Neurobehavior, Child Development, Lead Exposure, Child Injury, Adolescence, Adiposity, Neuroimaging
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lead Hazard Control InterventionProcedure or surgery
Prior to their child's birth, participants randomized to Lead Reduction Group received lead hazard reduction controls to reduce residential exposure to lead.
Injury Hazard Control InterventionProcedure or surgery
Between 3 and 6 months of age, participants randomized to Injury Reduction Arm received injury hazard controls to reduce the number of residential injuries.
| Study group | Role | What they receive |
|---|---|---|
| Lead Reduction Arm | Other | random assignment to receive lead hazard control intervention. Assessing lead hazards in the home. Reducing lead hazards by cleaning, painting, covering, and/or replacing/repairing interior and exterior components of the home. Receives: Procedure: Lead Hazard Control Intervention |
| Injury Reduction Arm | Other | random assignment to receive injury hazard control intervention. Assessing home for potential injury hazards. Controlling hazards by 1) installing safety equipment such as stairway gates, cabinet locks, smoke \& CO detectors, etc. 2) removing the hazards from the reach of a child and/or 3) restricting access to the hazards. Receives: Procedure: Injury Hazard Control Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lead reduction intervention, blood lead concentrations & neurobehavioral outcomes
Testing the efficacy of lead reduction controls in the homes of participants. Examining the effects of low level blood lead concentration on child development and neurobehavior. Measures of blood lead concentration were taken from mothers prenatally at approximately 16 and 26 weeks gestation, from cord blood at birth, and annually from participating children from 1 - 10 years of age.
Measured: 16wk & 26wk gestation, birth, annually at 1y-12y
Exposure to environmental chemicals and their effects on child health, neurobehavior and development
Addressing potential adverse health risks of environmental chemicals (persistent organic pollutants, metals, cotinine, pesticides, flame retardants, BPA, and phthalates) on fetal, infant, and child neurobehavior. Examining their associations with endocrine function, body composition (DXA), neuroimaging (MRI/fMRI), cognition, learning and memory, motor skills, attention and executive function, behavior, and mental health. Also examining exposures at different developmental stages and measuring child neurobehavior.
Measured: 16wk & 26wk gestation, birth, 4wk postnatal, annually years 1-12.
Injury prevention measures and household injuries
Test the efficacy of injury reduction controls in the homes of study participants. Assessed homes for potential injury hazards and installed child safety equipment. Collected parent report of injury events and validated the events against injuries tracked in the Hamilton County Injury Surveillance System
Measured: Postnatally up to age 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2005 (estimated)
- Study startMar 2003
- Primary completionAug 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (83)Papers the sponsor has linked to this study.
- Other trials for Environmental ExposuresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 468 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Kimberly Yolton, PhD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00129324
- Sponsor's protocol ID
- 11261-CP-001
- Other IDs
- R01ES014575, P01ES011261, R01ES020349, R01ES015517, R01ES025214, R01ES027224, R01ES028277, R01ES024381
- Status last verified
- Mar 2020
- First submitted
- 10 Aug 2005
- Last updated
- 6 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Lanphear BP, Hornung R, Khoury J, Yolton K, Baghurst P, Bellinger DC, Canfield RL, Dietrich KN, Bornschein R, Greene T, Rothenberg SJ, Needleman HL, Schnaas L, Wasserman G, Graziano J, Roberts R. Low-level environmental lead exposure and children's intellectual function: an international pooled analysis. Environ Health Perspect. 2005 Jul;113(7):894-9. doi: 10.1289/ehp.7688.
PubMed 16002379Phelan KJ, Khoury J, Xu Y, Lanphear B. Validation of a HOME Injury Survey. Inj Prev. 2009 Oct;15(5):300-6. doi: 10.1136/ip.2008.020958.
PubMed 19805597Spanier AJ, Wilson S, Ho M, Hornung R, Lanphear BP. The contribution of housing renovation to children's blood lead levels: a cohort study. Environ Health. 2013 Aug 27;12:72. doi: 10.1186/1476-069X-12-72.
PubMed 23981571Braun JM, Kalloo G, Chen A, Dietrich KN, Liddy-Hicks S, Morgan S, Xu Y, Yolton K, Lanphear BP. Cohort Profile: The Health Outcomes and Measures of the Environment (HOME) study. Int J Epidemiol. 2017 Feb 1;46(1):24. doi: 10.1093/ije/dyw006. No abstract available.
PubMed 27006352Li N, Yolton K, Lanphear BP, Chen A, Kalkwarf HJ, Braun JM. Impact of Early-Life Weight Status on Cognitive Abilities in Children. Obesity (Silver Spring). 2018 Jun;26(6):1088-1095. doi: 10.1002/oby.22192.
PubMed 29797555Bowers K, Khoury J, Sucharew H, Xu Y, Chen A, Lanphear B, Yolton K. Early Infant Attention as a Predictor of Social and Communicative Behavior in Childhood. Int J Behav Dev. 2019 May;43(3):204-211. doi: 10.1177/0165025418797001. Epub 2018 Sep 18.
PubMed 37736344Goetz AR, Beebe DW, Peugh JL, Mara CA, Lanphear BP, Braun JM, Yolton K, Stark LJ. Longer sleep duration during infancy and toddlerhood predicts weight normalization among high birth weight infants. Sleep. 2019 Feb 1;42(2):zsy214. doi: 10.1093/sleep/zsy214.
PubMed 30412240Sears CG, Braun JM, Ryan PH, Xu Y, Werner EF, Lanphear BP, Wellenius GA. The association of traffic-related air and noise pollution with maternal blood pressure and hypertensive disorders of pregnancy in the HOME study cohort. Environ Int. 2018 Dec;121(Pt 1):574-581. doi: 10.1016/j.envint.2018.09.049. Epub 2018 Oct 6.
PubMed 30300815Geraghty SR, Khoury JC, Morrow AL, Lanphear BP. Reporting individual test results of environmental chemicals in breastmilk: potential for premature weaning. Breastfeed Med. 2008 Dec;3(4):207-13. doi: 10.1089/bfm.2008.0120.
PubMed 19086823Braun JM, Yolton K, Dietrich KN, Hornung R, Ye X, Calafat AM, Lanphear BP. Prenatal bisphenol A exposure and early childhood behavior. Environ Health Perspect. 2009 Dec;117(12):1945-52. doi: 10.1289/ehp.0900979. Epub 2009 Oct 6.
PubMed 20049216Braun JM, Daniels JL, Poole C, Olshan AF, Hornung R, Bernert JT, Khoury J, Needham LL, Barr DB, Lanphear BP. Prenatal environmental tobacco smoke exposure and early childhood body mass index. Paediatr Perinat Epidemiol. 2010 Nov;24(6):524-34. doi: 10.1111/j.1365-3016.2010.01146.x. Epub 2010 Aug 16.
PubMed 20955230Braun JM, Daniels JL, Poole C, Olshan AF, Hornung R, Bernert JT, Xia Y, Bearer C, Barr DB, Lanphear BP. A prospective cohort study of biomarkers of prenatal tobacco smoke exposure: the correlation between serum and meconium and their association with infant birth weight. Environ Health. 2010 Aug 27;9:53. doi: 10.1186/1476-069X-9-53.
PubMed 20799929Braun JM, Kalkbrenner AE, Calafat AM, Bernert JT, Ye X, Silva MJ, Barr DB, Sathyanarayana S, Lanphear BP. Variability and predictors of urinary bisphenol A concentrations during pregnancy. Environ Health Perspect. 2011 Jan;119(1):131-7. doi: 10.1289/ehp.1002366.
PubMed 21205581Wilson SE, Baker ER, Leonard AC, Eckman MH, Lanphear BP. Understanding preferences for disclosure of individual biomarker results among participants in a longitudinal birth cohort. J Med Ethics. 2010 Dec;36(12):736-40. doi: 10.1136/jme.2010.036517. Epub 2010 Oct 8.
PubMed 20935315Xu Y, Yolton K, Khoury J. Earliest appropriate time for administering neurobehavioral assessment in newborn infants. Pediatrics. 2011 Jan;127(1):e69-75. doi: 10.1542/peds.2010-1121. Epub 2010 Dec 20.
PubMed 21172999
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurobehavioral Effects of Prevalent Neurotoxicants in Children: A Cohort Study of the Cincinnati Center for Children's Environmental Health
- ClinicalTrials.gov ID
- NCT00129324
- Acronym / sponsor ID
- 11261-CP-001
- Keywords
- HOME, Environmental Exposure, Neurobehavior, Child Development, Lead Exposure, Child Injury, Adolescence, Adiposity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 468 participants (actual)
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)US National Institutes of Health
- Study start
- Mar 2003 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 11 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of the HOME Study is to quantify the impact of low-level fetal and early childhood exposures to environmental toxicants including lead, mercury, and other metals, pesticides, polychlorinated biphenyls (PCBs), persistent organic pollutants (PBDEs/PFCs), phthalates, phenols, environmental tobacco smoke, and alcohol on child development, neurobehavior, health, and growth. The HOME Study will also evaluate meconium as a biomarker for fetal exposure and test the effectiveness of home repairs to control lead hazards and injuries in early childhood.
Detailed description
This study aims to examine the effects of low-level exposures to prevalent neurotoxicants on health, growth, and neurobehavior among a representative sample of children. Pregnant women were enrolled in the project around 16 weeks of gestation. In the first phase of the study, we followed children resulting from the pregnancy through the age of 36 months. The second phase extended follow-up through 72 months. Phase 3 extended follow-up to 8 years (range 7.5-10) with comprehensive neurobehavioral assessments. Phase 4 will allow follow-up at 12 years (range 11-13), and includes measures of health, growth and body composition, behavior and mental health, and neuroimaging. To address the potential adverse health risks of environmental chemicals, including persistent pollutants such as PBDEs and PFCs and other non-persistent chemicals, on fetal, infant, and child neurobehavior, the investigators are systematically examining their associations with endocrine function, cognition, learning and memory, motor skills, attention and executive function, and behavior from age 1 to 7.5-10 years. The investigators are also examining exposures at different developmental stages (in utero at 16 weeks of gestation, early childhood, school age, preadolescence) using stored biological samples and measure child neurobehavior at 1, 2, 3, 4, 5, 8, and 12 years. This longitudinal study will allow the investigators to determine the dose response, windows of susceptibility, and persistence of the association. The investigators are also examining the contribution of PBDE exposures from house dust in a subset of children who have complete sets of samples of maternal serum and child serum collected from annual visits along with extensive measures of mouthing behaviors.
Hypotheses from the four phases of the study are as follows:
- In utero exposures measured by survey (alcohol and ETS), maternal and cord blood (lead and mercury) maternal and cord serum (ETS), and urine (pesticides) are less predictive of in utero effects of prevalent toxicants, including cognition, behavior problems, and growth compared with the same toxicants in meconium.
- Prenatal and postnatal exposures to prevalent pesticides and ETS are associated with adverse neurobehavioral effects, and growth delay in children.
- Higher lead exposure, measured during pregnancy and early childhood using maternal blood, cord blood, meconium and children's blood, will be associated with lower IQ scores and more behavioral problems for children with a maximal blood lead level < 5 mg/dL.
- Children in the lead treatment arm will have: blood lead that is 2.7 mg/dL lower, higher IQ scores, greater growth velocity, and fewer behavioral problems than children in the control group.
- Levels of lead in dust, soil and water will be significantly lower for housing units in the lead treatment arm compared with the injury control arm at 36 and 48 month home visits.
- A multifactorial, housing intervention will reduce residential injury by 30 percent among children in the injury treatment arm compared with those in the lead treatment arm.
- Prenatal and Postnatal exposures to PBDEs and PFCs are associated with altered thyroid hormone levels and deficits in infant and child neurobehavior
- With increasing child age, PBDE exposure from household dust becomes a stronger predictor of child serum PBDE concentration than exposure from placenta or breast milk.
- Developmental PBDE and PFC exposures are associated with internalizing symptoms.
- Developmental PBDE and PFC exposures are associated with adverse changes in anatomical structure, neurochemistry, organization of white matter tracts, and connectivity of neural networks.
- PFAS affect the gene expression and function of several biological pathways that program the fetus/infant towards a 'thrifty phenotype'. This leads to accelerated early childhood growth, increased fat mass, and features of metabolic syndrome.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lead Reduction Arm | Other | Procedure: Lead Hazard Control Interventionrandom assignment to receive lead hazard control intervention. Assessing lead hazards in the home. Reducing lead hazards by cleaning, painting, covering, and/or replacing/repairing interior and exterior components of the home. |
| Injury Reduction Arm | Other | Procedure: Injury Hazard Control Interventionrandom assignment to receive injury hazard control intervention. Assessing home for potential injury hazards. Controlling hazards by 1) installing safety equipment such as stairway gates, cabinet locks, smoke \& CO detectors, etc. 2) removing the hazards from the reach of a child and/or 3) restricting access to the hazards. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Pregnancy
- Participating prenatal practice/clinic
- Participating hospital
Key exclusion criteria (12 listed)
- Residence outside study area
- Plans to move outside study area within 1 year
- Home built after 1978
- Less than 18 years of age
- Beyond 19 weeks of gestation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lead Hazard Control InterventionPrior to their child's birth, participants randomized to Lead Reduction Group received lead hazard reduction controls to reduce residential exposure to lead. | Procedure or surgery | Lead Reduction Arm |
| Injury Hazard Control InterventionBetween 3 and 6 months of age, participants randomized to Injury Reduction Arm received injury hazard controls to reduce the number of residential injuries. | Procedure or surgery | Injury Reduction Arm |
Primary outcome
Lead reduction intervention, blood lead concentrations & neurobehavioral outcomes
Time frame: 16wk & 26wk gestation, birth, annually at 1y-12y
Testing the efficacy of lead reduction controls in the homes of participants. Examining the effects of low level blood lead concentration on child development and neurobehavior. Measures of blood lead concentration were taken from mothers prenatally at approximately 16 and 26 weeks gestation, from cord blood at birth, and annually from participating children from 1 - 10 years of age.
Exposure to environmental chemicals and their effects on child health, neurobehavior and development
Time frame: 16wk & 26wk gestation, birth, 4wk postnatal, annually years 1-12.
Addressing potential adverse health risks of environmental chemicals (persistent organic pollutants, metals, cotinine, pesticides, flame retardants, BPA, and phthalates) on fetal, infant, and child neurobehavior. Examining their associations with endocrine function, body composition (DXA), neuroimaging (MRI/fMRI), cognition, learning and memory, motor skills, attention and executive function, behavior, and mental health. Also examining exposures at different developmental stages and measuring child neurobehavior.
Injury prevention measures and household injuries
Time frame: Postnatally up to age 5 years
Test the efficacy of injury reduction controls in the homes of study participants. Assessed homes for potential injury hazards and installed child safety equipment. Collected parent report of injury events and validated the events against injuries tracked in the Hamilton County Injury Surveillance System
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2020.
- Background: PubMed 16002379Lanphear BP, Hornung R, Khoury J, Yolton K, Baghurst P, Bellinger DC, Canfield RL, Dietrich KN, Bornschein R, Greene T, Rothenberg SJ, Needleman HL, Schnaas L, Wasserman G, Graziano J, Roberts R. Low-level environmental lead exposure and children's intellectual function: an international pooled analysis. Environ Health Perspect. 2005 Jul;113(7):894-9. doi: 10.1289/ehp.7688.
- Background: PubMed 19805597Phelan KJ, Khoury J, Xu Y, Lanphear B. Validation of a HOME Injury Survey. Inj Prev. 2009 Oct;15(5):300-6. doi: 10.1136/ip.2008.020958.
- Background: PubMed 23981571Spanier AJ, Wilson S, Ho M, Hornung R, Lanphear BP. The contribution of housing renovation to children's blood lead levels: a cohort study. Environ Health. 2013 Aug 27;12:72. doi: 10.1186/1476-069X-12-72.
- Background: PubMed 27006352Braun JM, Kalloo G, Chen A, Dietrich KN, Liddy-Hicks S, Morgan S, Xu Y, Yolton K, Lanphear BP. Cohort Profile: The Health Outcomes and Measures of the Environment (HOME) study. Int J Epidemiol. 2017 Feb 1;46(1):24. doi: 10.1093/ije/dyw006. No abstract available.
- Background: PubMed 29797555Li N, Yolton K, Lanphear BP, Chen A, Kalkwarf HJ, Braun JM. Impact of Early-Life Weight Status on Cognitive Abilities in Children. Obesity (Silver Spring). 2018 Jun;26(6):1088-1095. doi: 10.1002/oby.22192.
- Background: PubMed 37736344Bowers K, Khoury J, Sucharew H, Xu Y, Chen A, Lanphear B, Yolton K. Early Infant Attention as a Predictor of Social and Communicative Behavior in Childhood. Int J Behav Dev. 2019 May;43(3):204-211. doi: 10.1177/0165025418797001. Epub 2018 Sep 18.
- Background: PubMed 30412240Goetz AR, Beebe DW, Peugh JL, Mara CA, Lanphear BP, Braun JM, Yolton K, Stark LJ. Longer sleep duration during infancy and toddlerhood predicts weight normalization among high birth weight infants. Sleep. 2019 Feb 1;42(2):zsy214. doi: 10.1093/sleep/zsy214.
- Background: PubMed 30300815Sears CG, Braun JM, Ryan PH, Xu Y, Werner EF, Lanphear BP, Wellenius GA. The association of traffic-related air and noise pollution with maternal blood pressure and hypertensive disorders of pregnancy in the HOME study cohort. Environ Int. 2018 Dec;121(Pt 1):574-581. doi: 10.1016/j.envint.2018.09.049. Epub 2018 Oct 6.
- Results publication: PubMed 19086823Geraghty SR, Khoury JC, Morrow AL, Lanphear BP. Reporting individual test results of environmental chemicals in breastmilk: potential for premature weaning. Breastfeed Med. 2008 Dec;3(4):207-13. doi: 10.1089/bfm.2008.0120.
- Results publication: PubMed 20049216Braun JM, Yolton K, Dietrich KN, Hornung R, Ye X, Calafat AM, Lanphear BP. Prenatal bisphenol A exposure and early childhood behavior. Environ Health Perspect. 2009 Dec;117(12):1945-52. doi: 10.1289/ehp.0900979. Epub 2009 Oct 6.
- Results publication: PubMed 20955230Braun JM, Daniels JL, Poole C, Olshan AF, Hornung R, Bernert JT, Khoury J, Needham LL, Barr DB, Lanphear BP. Prenatal environmental tobacco smoke exposure and early childhood body mass index. Paediatr Perinat Epidemiol. 2010 Nov;24(6):524-34. doi: 10.1111/j.1365-3016.2010.01146.x. Epub 2010 Aug 16.
- Results publication: PubMed 20799929Braun JM, Daniels JL, Poole C, Olshan AF, Hornung R, Bernert JT, Xia Y, Bearer C, Barr DB, Lanphear BP. A prospective cohort study of biomarkers of prenatal tobacco smoke exposure: the correlation between serum and meconium and their association with infant birth weight. Environ Health. 2010 Aug 27;9:53. doi: 10.1186/1476-069X-9-53.
- Related InfoLink provided by the sponsor.
Related trials for Environmental Exposures
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Enrolling by invitationObservational study
Mayo Clinic Tapestry 2.0: Applying Multi-Omics for Scientific Discovery
Genetic Predisposition, Exposure, Environmental
Not yet recruiting
Sperm, Exposure and Endocrine Disruptors
Fertility, Male Fertility
RecruitingObservational study
Cadmium Exposure During Pregnancy and Fetal Growth
Cadmium, Placenta
RecruitingObservational study
Environmental Exposure Assessment in High-Risk and Early-Onset Breast Cancer Care
Breast Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kimberly Yolton, PhD principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Environmental Exposures and Child Development, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lead reduction intervention, blood lead concentrations & neurobehavioral outcomes (time frame: 16wk & 26wk gestation, birth, annually at 1y-12y). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00129324, which also lists 83 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2020.