InfantNCT00852904
National Children s Health Study
An observational study of Infant and Child Development, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 4 sites in United States.
Trial summary
Patterns of illness among children in the United States and other industrially developed nations have changed substantially during the past 100 years. Before and during the first half of the previous century, infectious diseases were the primary threat to children s health. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infant, Child Development, Biological Samples
- How many people
- 9,942 participants
- Where
- 4 sitesUnited States
- Study dates
- 25 Feb 2009to 29 May 2020
- Phase
- Observational
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Women of child bearing potential, their children, the children's biological and/or ocial fathers, and primary caregivers (if other than parent)
Who may be able to join
None listed.
Who cannot join
- Women self-reported to be infertile
- Adults who are unable to understand what is involved in NCS participation and grant informed consent
- Prisoners as defined in 45 CFR 46.303[c]
Trial locations and contacts
4 sites in 1 country.
United States4 sites
National Institute of Child Health and Human Development (NICHD), 9000 Rockville
Bethesda, Maryland, 20892
Northwestern University
Chicago, Illinois, 60611
NORC at the Univ. of Chicago
Chicago, Illinois
Westat, Inc.
Rockville, Maryland, 20850
About this study
Official title: Vanguard Phase of the National Children s Study
Patterns of illness among children in the United States and other industrially developed nations have changed substantially during the past 100 years. Before and during the first half of the previous century, infectious diseases were the primary threat to children s health. In contrast, the major illnesses and disorders that impair health, growth, and development today are chronic conditions stemming from the complex interaction of environmental exposures and inherent genetic factors. The Children s Health Act of 2000 directed the National Institute of Child Health and Development to conduct a national longitudinal study of environmental influences on children s health in the United States. The act specified that the study extend from the prenatal period to adulthood and investigate the short-term and long-term influences of physical, chemical, biological, and psychosocial environmental exposures on children s health and development, including behavioral, emotional, and educational outcomes in addition to physical health. The National Children s Study (NCS) is an observational longitudinal study that will enroll and follow a nationally representative sample of approximately 100,000 U.S.-born children from before birth through their 21st birthday. The study will screen all households within selected areas of 105 locations (primarily counties).
The major types of analysis of NCS data will include longitudinal exposure-outcome analysis, identification of causal pathways, analysis of neighborhood effects, evaluation of temporal effects within longitudinal data analysis of data from case-control data, and analysis of genomic data.
Read more
Women in their first trimester of pregnancy will be invited to participate in the pre-pregnancy portion of the NCS. Women who are not pregnant but have a high probability of becoming pregnant will be asked to participate in the early pregnancy portion of the NCS. All other eligible women will be asked if the study can contact them periodically to assess their pregnancy status. They also will be asked to contact the NCS should they become pregnant. Women identified as pregnant within 4 years after initial screening will be invited to enroll in the NCS.
The following information will be gathered:
Mother s data and information
- Questionnaire data interviewed and self-administered (e.g., demographics; current pregnancy history; reproductive history; medical conditions; health behaviors; doctor visits; medicines and supplements; housing characteristics; pesticides, product use; occupation, hobbies; depression, stress; social support; diet; time and activity)
- Physical measures and clinical data (e.g., blood pressure, sonograms, height, weight, body measurements)
- Biologic specimens (e.g., blood, urine, hair, saliva)
- Environmental samples during home visits (e.g., dust, air, water)
- Medical record abstraction
Infant s data and information at birth
- Cord blood and tissue samples of the placenta and umbilical cord
- Standardized neurobehavioral exam
- Physical measures and clinical data (e.g., length; weight; circumferences of head, arm, abdomen, thigh)
- Meconium samples
- Medical diagnoses and treatment by report
- Selected Medical record abstraction
Read the detailed description
The National Children s Study (NCS) is a planned, observational, and longitudinal study that will enroll and follow a national sample of approximately 100,000 children born in the United States (US) to participating women from before birth through the child s 21st birthday. The goal of the NCS is to provide information that will ultimately lead to improvements in the health, development, and well-being of children. The primary aim of the NCS is to investigate the separate and combined effects of environmental exposures (chemical, biological, physical, and psychosocial) as well as gene-environment interactions on pregnancy outcomes, child health and development, and precursors of adult disease. In-person contacts with the NCS participants include visits during pregnancy, after delivery, and throughout infancy and childhood at the participant s home and sometimes in a clinical setting. The collection of biospecimens, environmental samples, and physical measures is involved in addition to the examination of the infant and periodic contacts with the family. In addition, interim phone interviews regularly occur with in-person contacts. The NCS consists of the NCS Vanguard Study with any sub-studies and the NCS Main Study with any sub-studies. The Vanguard Study is the precursor to the Main Study.
The NCS Vanguard Study is designed and implemented to determine the feasibility, acceptability and cost of the elements that will form the Main Study. The Vanguard Study enrolls participants at forty Study locations and will have a planned duration of 21 years following completion of enrollment. The Vanguard Study will precede the Main Study on an ongoing basis to pilot all aspects of the Main Study. The specific objectives of the Vanguard Study are:
- Evaluation of recruitment, enrollment and retention strategies
- Evaluation of study logistics and operations including sites and mechanisms of data acquisition, collection, transport and storage of environmental and biological samples, and design and performance of information systems
- Evaluation of study visit assessments for feasibility, acceptability, reliability, reproducibility, cost, value, stability, and redundancy with other assessments
Families who participate in the NCS will come from forty Study locations across the US. Study visit assessments are the tests, environmental samples, biospecimens, questionnaires and other forms of data acquisition that are scheduled at the study visits. The evaluation of the Vanguard Study will be based on a series of targeted and specific statistical techniques and tests selected for each evaluation. Multiple performance measures will be used to inform the scope, design, visit structure and schedule, mechanisms and procedures, and analysis plan for the Main Study.
- Conditions
- Infant, Child Development, Biological Samples
- Keywords
- Childhood Growth and Development, Genetics, Children, Environment, Longitudinal Study, National Children's Study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| NCS Vanguard cohort | Women of child bearing potential, children born to women enrolled in the study, the children s biological and/or social fathers, and primary caregivers (if other than parent) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess feasibility, acceptability and cost of: Recruitment, accrual, enrollment and retention strategies; Study logistics and operations; Study visit assessments including newly developed assessmentsfor reliability, reproducibility and stabil...
Feasibility, acceptability and cost of the elements that will form the Main Study
Measured: During and after pregnancy, throughout infancy and childhood until age 21
Secondary outcomes (1)
Evaluation of recruitment, enrollment and retention strategies
Recruitment, enrollment and retention
Measured: Ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2009 (estimated)
- Study start25 Feb 2009
- Primary completion12 Dec 2014
- Study completion29 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for InfantStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 9,942 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Jack Moye, M.D., Principal investigator, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00852904
- Sponsor's protocol ID
- 999909083
- Other IDs
- 09-CH-N083
- Status last verified
- May 2020
- First submitted
- 26 Feb 2009
- Last updated
- 1 Jun 2020
- Results posted
- No
Publications
Hudak ML, Park CH, Annett RD, Hale DE, McGovern PM, McLaughlin TJ, Dole N, Kaar JL, Balsam MJ. The National Children's Study: An Introduction and Historical Overview. Pediatrics. 2016 Jun;137 Suppl 4(Suppl 4):S213-8. doi: 10.1542/peds.2015-4410B.
PubMed 27251867Li Q, Kappil MA, Li A, Dassanayake PS, Darrah TH, Friedman AE, Friedman M, Lambertini L, Landrigan P, Stodgell CJ, Xia Y, Nanes JA, Aagaard KM, Schadt EE, Murray JC, Clark EB, Dole N, Culhane J, Swanson J, Varner M, Moye J, Kasten C, Miller RK, Chen J. Exploring the associations between microRNA expression profiles and environmental pollutants in human placenta from the National Children's Study (NCS). Epigenetics. 2015;10(9):793-802. doi: 10.1080/15592294.2015.1066960. Epub 2015 Aug 7.
PubMed 26252056Park CH, Winglee M, Kwan J, Andrews L, Hudak ML. Comparison of Recruitment Strategy Outcomes in the National Children's Study. Pediatrics. 2017 Aug;140(2):e20162822. doi: 10.1542/peds.2016-2822.
PubMed 28724571Gilbertson PK, Forrester S, Andrews L, McCann K, Rogers L, Park C, Moye J. The National Children's Study Archive Model: A 3-Tier Framework for Dissemination of Data and Specimens for General Use and Secondary Analysis. Front Public Health. 2021 Mar 5;9:526286. doi: 10.3389/fpubh.2021.526286. eCollection 2021.
PubMed 33748052Kaar JL, Markovic N, Amsden LB, Gilliland J, Shorter CF, Peters B, Nachreiner NM, Garel M, Nicholas W, Skarpness B, Drews-Botsch C, Hogue CJ, Dabelea D. The Experience of Direct Outreach Recruitment in the National Children's Study. Pediatrics. 2016 Jun;137 Suppl 4(Suppl 4):S258-64. doi: 10.1542/peds.2015-4410G.
PubMed 27251872McLaughlin TJ, Aupont O, Kozinetz CA, Hubble D, Moore-Simas TA, Davis D, Park C, Brenner R, Sepavich D, Felice M, Caviness C, Downs T, Selwyn BJ, Forman MR. Multilevel Provider-Based Sampling for Recruitment of Pregnant Women and Mother-Newborn Dyads. Pediatrics. 2016 Jun;137 Suppl 4(Suppl 4):S248-57. doi: 10.1542/peds.2015-4410F.
PubMed 27251871Hale DE, Wyatt SB, Buka S, Cherry D, Cislo KK, Dudley DJ, McElfish PA, Norman GS, Reynolds SA, Siega-Riz AM, Wadlinger S, Walker CK, Robbins JM. The National Children's Study: Recruitment Outcomes Using the Provider-Based Recruitment Approach. Pediatrics. 2016 Jun;137 Suppl 4(Suppl 4):S239-47. doi: 10.1542/peds.2015-4410E.
PubMed 27251870McGovern PM, Nachreiner NM, Holl JL, Halfon N, Dabelea D, Caulfield L, Cauley JA, Innocenti MS, Amsden L, Markovic N, Riddles M, Adams S. The National Children's Study: Early Recruitment Outcomes Using the Direct Outreach Approach. Pediatrics. 2016 Jun;137 Suppl 4(Suppl 4):S231-8. doi: 10.1542/peds.2015-4410D.
PubMed 27251869Trasande L, Andrews HF, Goranson C, Li W, Barrow EC, Vanderbeek SB, McCrary B, Allen SB, Gallagher KD, Rundle A, Quinn J, Brenner B. Early experiences and predictors of recruitment success for the National Children's Study. Pediatrics. 2011 Feb;127(2):261-8. doi: 10.1542/peds.2010-2334. Epub 2011 Jan 24.
PubMed 21262893
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vanguard Phase of the National Children s Study
- ClinicalTrials.gov ID
- NCT00852904
- Acronym / sponsor ID
- 999909083
- Conditions
- Infant, Child Development, Biological Samples
- Keywords
- Childhood Growth and Development, Genetics, Children, Environment, Longitudinal Study, National Children's Study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9,942 participants (actual)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- 25 Feb 2009 (actual)
- Primary completion
- 12 Dec 2014 (actual)
- Study completion
- 29 May 2020 (actual)
- First posted
- 27 Feb 2009 (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.
Patterns of illness among children in the United States and other industrially developed nations have changed substantially during the past 100 years. Before and during the first half of the previous century, infectious diseases were the primary threat to children s health. In contrast, the major illnesses and disorders that impair health, growth, and development today are chronic conditions stemming from the complex interaction of environmental exposures and inherent genetic factors. The Children s Health Act of 2000 directed the National Institute of Child Health and Development to conduct a national longitudinal study of environmental influences on children s health in the United States. The act specified that the study extend from the prenatal period to adulthood and investigate the short-term and long-term influences of physical, chemical, biological, and psychosocial environmental exposures on children s health and development, including behavioral, emotional, and educational outcomes in addition to physical health. The National Children s Study (NCS) is an observational longitudinal study that will enroll and follow a nationally representative sample of approximately 100,000 U.S.-born children from before birth through their 21st birthday. The study will screen all households within selected areas of 105 locations (primarily counties).
The major types of analysis of NCS data will include longitudinal exposure-outcome analysis, identification of causal pathways, analysis of neighborhood effects, evaluation of temporal effects within longitudinal data analysis of data from case-control data, and analysis of genomic data.
Women in their first trimester of pregnancy will be invited to participate in the pre-pregnancy portion of the NCS. Women who are not pregnant but have a high probability of becoming pregnant will be asked to participate in the early pregnancy portion of the NCS. All other eligible women will be asked if the study can contact them periodically to assess their pregnancy status. They also will be asked to contact the NCS should they become pregnant. Women identified as pregnant within 4 years after initial screening will be invited to enroll in the NCS.
The following information will be gathered:
Mother s data and information
- Questionnaire data interviewed and self-administered (e.g., demographics; current pregnancy history; reproductive history; medical conditions; health behaviors; doctor visits; medicines and supplements; housing characteristics; pesticides, product use; occupation, hobbies; depression, stress; social support; diet; time and activity)
- Physical measures and clinical data (e.g., blood pressure, sonograms, height, weight, body measurements)
- Biologic specimens (e.g., blood, urine, hair, saliva)
- Environmental samples during home visits (e.g., dust, air, water)
- Medical record abstraction
Infant s data and information at birth
- Cord blood and tissue samples of the placenta and umbilical cord
- Standardized neurobehavioral exam
- Physical measures and clinical data (e.g., length; weight; circumferences of head, arm, abdomen, thigh)
- Meconium samples
- Medical diagnoses and treatment by report
- Selected Medical record abstraction
Detailed description
The National Children s Study (NCS) is a planned, observational, and longitudinal study that will enroll and follow a national sample of approximately 100,000 children born in the United States (US) to participating women from before birth through the child s 21st birthday. The goal of the NCS is to provide information that will ultimately lead to improvements in the health, development, and well-being of children. The primary aim of the NCS is to investigate the separate and combined effects of environmental exposures (chemical, biological, physical, and psychosocial) as well as gene-environment interactions on pregnancy outcomes, child health and development, and precursors of adult disease. In-person contacts with the NCS participants include visits during pregnancy, after delivery, and throughout infancy and childhood at the participant s home and sometimes in a clinical setting. The collection of biospecimens, environmental samples, and physical measures is involved in addition to the examination of the infant and periodic contacts with the family. In addition, interim phone interviews regularly occur with in-person contacts. The NCS consists of the NCS Vanguard Study with any sub-studies and the NCS Main Study with any sub-studies. The Vanguard Study is the precursor to the Main Study.
The NCS Vanguard Study is designed and implemented to determine the feasibility, acceptability and cost of the elements that will form the Main Study. The Vanguard Study enrolls participants at forty Study locations and will have a planned duration of 21 years following completion of enrollment. The Vanguard Study will precede the Main Study on an ongoing basis to pilot all aspects of the Main Study. The specific objectives of the Vanguard Study are:
- Evaluation of recruitment, enrollment and retention strategies
- Evaluation of study logistics and operations including sites and mechanisms of data acquisition, collection, transport and storage of environmental and biological samples, and design and performance of information systems
- Evaluation of study visit assessments for feasibility, acceptability, reliability, reproducibility, cost, value, stability, and redundancy with other assessments
Families who participate in the NCS will come from forty Study locations across the US. Study visit assessments are the tests, environmental samples, biospecimens, questionnaires and other forms of data acquisition that are scheduled at the study visits. The evaluation of the Vanguard Study will be based on a series of targeted and specific statistical techniques and tests selected for each evaluation. Multiple performance measures will be used to inform the scope, design, visit structure and schedule, mechanisms and procedures, and analysis plan for the Main Study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NCS Vanguard cohort | – | –Women of child bearing potential, children born to women enrolled in the study, the children s biological and/or social fathers, and primary caregivers (if other than parent) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women of child bearing potential, their children, the children's biological and/or ocial fathers, and primary caregivers (if other than parent)
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- Women self-reported to be infertile
- Adults who are unable to understand what is involved in NCS participation and grant informed consent
- Prisoners as defined in 45 CFR 46.303[c]
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assess feasibility, acceptability and cost of: Recruitment, accrual, enrollment and retention strategies; Study logistics and operations; Study visit assessments including newly developed assessmentsfor reliability, reproducibility and stabil...
Time frame: During and after pregnancy, throughout infancy and childhood until age 21
Feasibility, acceptability and cost of the elements that will form the Main Study
1 secondary outcome
Evaluation of recruitment, enrollment and retention strategies
Time frame: Ongoing
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 1 Jun 2020.
- Background: PubMed 27251867Hudak ML, Park CH, Annett RD, Hale DE, McGovern PM, McLaughlin TJ, Dole N, Kaar JL, Balsam MJ. The National Children's Study: An Introduction and Historical Overview. Pediatrics. 2016 Jun;137 Suppl 4(Suppl 4):S213-8. doi: 10.1542/peds.2015-4410B.
- Background: PubMed 26252056Li Q, Kappil MA, Li A, Dassanayake PS, Darrah TH, Friedman AE, Friedman M, Lambertini L, Landrigan P, Stodgell CJ, Xia Y, Nanes JA, Aagaard KM, Schadt EE, Murray JC, Clark EB, Dole N, Culhane J, Swanson J, Varner M, Moye J, Kasten C, Miller RK, Chen J. Exploring the associations between microRNA expression profiles and environmental pollutants in human placenta from the National Children's Study (NCS). Epigenetics. 2015;10(9):793-802. doi: 10.1080/15592294.2015.1066960. Epub 2015 Aug 7.
- Background: PubMed 28724571Park CH, Winglee M, Kwan J, Andrews L, Hudak ML. Comparison of Recruitment Strategy Outcomes in the National Children's Study. Pediatrics. 2017 Aug;140(2):e20162822. doi: 10.1542/peds.2016-2822.
- Derived from this study: PubMed 33748052Gilbertson PK, Forrester S, Andrews L, McCann K, Rogers L, Park C, Moye J. The National Children's Study Archive Model: A 3-Tier Framework for Dissemination of Data and Specimens for General Use and Secondary Analysis. Front Public Health. 2021 Mar 5;9:526286. doi: 10.3389/fpubh.2021.526286. eCollection 2021.
- Derived from this study: PubMed 27251872Kaar JL, Markovic N, Amsden LB, Gilliland J, Shorter CF, Peters B, Nachreiner NM, Garel M, Nicholas W, Skarpness B, Drews-Botsch C, Hogue CJ, Dabelea D. The Experience of Direct Outreach Recruitment in the National Children's Study. Pediatrics. 2016 Jun;137 Suppl 4(Suppl 4):S258-64. doi: 10.1542/peds.2015-4410G.
- Derived from this study: PubMed 27251871McLaughlin TJ, Aupont O, Kozinetz CA, Hubble D, Moore-Simas TA, Davis D, Park C, Brenner R, Sepavich D, Felice M, Caviness C, Downs T, Selwyn BJ, Forman MR. Multilevel Provider-Based Sampling for Recruitment of Pregnant Women and Mother-Newborn Dyads. Pediatrics. 2016 Jun;137 Suppl 4(Suppl 4):S248-57. doi: 10.1542/peds.2015-4410F.
- Derived from this study: PubMed 27251870Hale DE, Wyatt SB, Buka S, Cherry D, Cislo KK, Dudley DJ, McElfish PA, Norman GS, Reynolds SA, Siega-Riz AM, Wadlinger S, Walker CK, Robbins JM. The National Children's Study: Recruitment Outcomes Using the Provider-Based Recruitment Approach. Pediatrics. 2016 Jun;137 Suppl 4(Suppl 4):S239-47. doi: 10.1542/peds.2015-4410E.
- Derived from this study: PubMed 27251869McGovern PM, Nachreiner NM, Holl JL, Halfon N, Dabelea D, Caulfield L, Cauley JA, Innocenti MS, Amsden L, Markovic N, Riddles M, Adams S. The National Children's Study: Early Recruitment Outcomes Using the Direct Outreach Approach. Pediatrics. 2016 Jun;137 Suppl 4(Suppl 4):S231-8. doi: 10.1542/peds.2015-4410D.
- Derived from this study: PubMed 21262893Trasande L, Andrews HF, Goranson C, Li W, Barrow EC, Vanderbeek SB, McCrary B, Allen SB, Gallagher KD, Rundle A, Quinn J, Brenner B. Early experiences and predictors of recruitment success for the National Children's Study. Pediatrics. 2011 Feb;127(2):261-8. doi: 10.1542/peds.2010-2334. Epub 2011 Jan 24.
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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.
Jack Moye, M.D. principal investigator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infant and Child Development, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 4 sites 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 0 inclusion and 3 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 1 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Assess feasibility, acceptability and cost of: Recruitment, accrual, enrollment and retention strategies; Study logistics and operations; Study visit assessments including newly developed assessmentsfor reliability, reproducibility and stabil... (time frame: During and after pregnancy, throughout infancy and childhood until age 21). 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 NCT00852904, which also lists 9 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 1 Jun 2020.