Neurodevelopment Clinical Trial
Official title:
Prenatal and Childhood Nutrient Mixtures Predict Neurodevelopmental Outcomes Among Children in Mexico City
Verified date | October 2019 |
Source | Icahn School of Medicine at Mount Sinai |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Background: Adequate levels of beneficial nutrients are important for neurodevelopment.
Although, nutrients are ingested in combination, considering nutrients as a mixture has not
been studied with respect to health, such as neurodevelopment.
Objective: To examine the impact of prenatal and childhood nutrition mixtures on
neurodevelopment.
Design: Participants included mother-child pairs in the Programming Research in Obesity,
Growth Environment and Social Stress (PROGRESS) prospective birth cohort in Mexico City.
Prenatal and child nutrition profiles were assessed among 65 and 329 children respectively by
analyzing components of a food frequency questionnaire. Child neurodevelopmental outcomes at
4-6 years of age were measured using the McCarthy Scales of Children's Abilities (MSCA).
Status | Completed |
Enrollment | 329 |
Est. completion date | August 15, 2018 |
Est. primary completion date | August 15, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 44 Years |
Eligibility |
Inclusion Criteria: Women of children: - less than 20 weeks gestation at the start of the study - at least 18 years of age - and planned to reside in Mexico City for the next three years. Exclusion Criteria: Women of children: - free of heart or kidney disease - not use steroids or anti-epilepsy drugs - not consume alcohol. |
Country | Name | City | State |
---|---|---|---|
Mexico | National Institute of Public Health | Mexico City |
Lead Sponsor | Collaborator |
---|---|
Icahn School of Medicine at Mount Sinai |
Mexico,
Burris HH, Baccarelli AA, Byun HM, Cantoral A, Just AC, Pantic I, Solano-Gonzalez M, Svensson K, Tamayo y Ortiz M, Zhao Y, Wright RO, Téllez-Rojo MM. Offspring DNA methylation of the aryl-hydrocarbon receptor repressor gene is associated with maternal BMI, gestational age, and birth weight. Epigenetics. 2015;10(10):913-21. doi: 10.1080/15592294.2015.1078963. Epub 2015 Aug 7. — View Citation
Muñoz-Rocha TV, Tamayo Y Ortiz M, Romero M, Pantic I, Schnaas L, Bellinger D, Claus-Henn B, Wright R, Wright RO, Téllez-Rojo MM. Prenatal co-exposure to manganese and depression and 24-months neurodevelopment. Neurotoxicology. 2018 Jan;64:134-141. doi: 10.1016/j.neuro.2017.07.007. Epub 2017 Jul 17. — View Citation
Renzetti S, Just AC, Burris HH, Oken E, Amarasiriwardena C, Svensson K, Mercado-García A, Cantoral A, Schnaas L, Baccarelli AA, Wright RO, Téllez-Rojo MM. The association of lead exposure during pregnancy and childhood anthropometry in the Mexican PROGRESS cohort. Environ Res. 2017 Jan;152:226-232. doi: 10.1016/j.envres.2016.10.014. Epub 2016 Oct 28. — View Citation
Rodosthenous RS, Burris HH, Svensson K, Amarasiriwardena CJ, Cantoral A, Schnaas L, Mercado-García A, Coull BA, Wright RO, Téllez-Rojo MM, Baccarelli AA. Prenatal lead exposure and fetal growth: Smaller infants have heightened susceptibility. Environ Int. 2017 Feb;99:228-233. doi: 10.1016/j.envint.2016.11.023. Epub 2016 Dec 5. — View Citation
Rosa MJ, Just AC, Guerra MS, Kloog I, Hsu HL, Brennan KJ, García AM, Coull B, Wright RJ, Téllez Rojo MM, Baccarelli AA, Wright RO. Identifying sensitive windows for prenatal particulate air pollution exposure and mitochondrial DNA content in cord blood. Environ Int. 2017 Jan;98:198-203. doi: 10.1016/j.envint.2016.11.007. Epub 2016 Nov 11. — View Citation
Sanders AP, Burris HH, Just AC, Motta V, Svensson K, Mercado-Garcia A, Pantic I, Schwartz J, Tellez-Rojo MM, Wright RO, Baccarelli AA. microRNA expression in the cervix during pregnancy is associated with length of gestation. Epigenetics. 2015;10(3):221-8. doi: 10.1080/15592294.2015.1006498. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | McCarthy Scales of Children's Abilities (MSCA) | The MSCA consists of 18 short sub-tests that are weighted and combined to yield five scale scores or indexes - verbal, perceptual performance, quantitative, memory and motor - as well as an overall general cognitive index based on the first three scaled indexes. The McCarthy Scale index scores can range from 22 - 78 with higher index scores indicating better outcome. | at age 4 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT02184780 -
Impact of Perinatal Anaesthesia and Analgesia on Neurocognitive Outcomes in Early Childhood
|
||
Not yet recruiting |
NCT06429007 -
A Safety and Feasibility Trial Protocol of Metformin in Infants After Perinatal Brain Injury
|
Phase 2 | |
Completed |
NCT02208960 -
Newborn Kit to Save Lives and Brains in Kenya
|
Phase 3 | |
Recruiting |
NCT03633162 -
Maternal Grandmothers in the Born in Guangzhou Cohort Study
|
||
Recruiting |
NCT04137445 -
The Effects of Early Complementary Feeding on Growth, Neurodevelopment, Sleep and Gut Health
|
N/A | |
Completed |
NCT02759263 -
Improving Neurodevelopment in Adolescents With Congenital Heart Disease
|
N/A | |
Recruiting |
NCT04593095 -
Nurturing and Quiet Intervention: NeuroN-QI
|
N/A | |
Withdrawn |
NCT05045092 -
A Follow-up Study of Neonates Receiving Extracorporeal Life Support in China
|
||
Recruiting |
NCT03629093 -
Neurodevelopment of Infants Exposed to General Anesthesia: a Multi-center Investigation
|
||
Recruiting |
NCT04529889 -
GDM and Its Consequences in Mothers and Offsprings
|
||
Recruiting |
NCT03650829 -
IVF Offspring Born in Guangzhou
|
||
Recruiting |
NCT03668327 -
Preterm Birth Cohort Study in Guangzhou
|
||
Recruiting |
NCT03331133 -
Twins Born in Guangzhou
|
||
Recruiting |
NCT02526901 -
The Born in Guangzhou Cohort Study (BIGCS)
|
||
Completed |
NCT02610959 -
Iodine Status During Pregnancy and Its Effect on Infant Development.
|
N/A | |
Recruiting |
NCT01609894 -
Individualized Fortification of Breast Milk
|
N/A | |
Not yet recruiting |
NCT05977400 -
NICU Antibiotics and Outcomes (NANO) Follow-up Study
|
Phase 3 |