Early Risk of Asthma in Children Exposed to In-utero Maternal Obesity
2 other identifiers
observational
240
0 countries
N/A
Brief Summary
This study seeks a better understanding of the pathogenesis of asthma in early life. The aim of this project is to determine whether the offspring of obese mothers at 3 years of life have increased the risk of asthma compared to children whose mothers were not obese and whether this increased risk is associated with a programming altered immune reactivity at birth.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2014
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
September 13, 2016
CompletedFirst Posted
Study publicly available on registry
September 16, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2018
CompletedSeptember 10, 2021
June 1, 2018
3.6 years
September 13, 2016
September 2, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Risk of asthma (defined as "positive asthma predictive index" at 36 months of age)
36 months of age
Secondary Outcomes (1)
Allergy status (positive skin prick test)
30-36 months of age
Study Arms (1)
Newborn from obese and nonobese pregnant
Obese (BMI\>30) or normal weight (BMI\<25) women at their first antenatal visit were invited to participate in the study at the moment of delivery at Sotero del Rio Hospital, Santiago. Information regarding birth outcomes, parental history, as well as environmental conditions was collected at recruitment. Follow-up questionnaires by phone were completed every 6 months. Umbilical cord blood samples were collected to measure IL-12, TNF-α, IL-10, IL-4; to evaluate metabolic status; to isolated monocytes and macrophage differentiation; and for DNA methylation status of the promoter regions of the genes coding for TNF-α, IL-12, IL-10, and IL-4Rα. Also, fasting blood samples of the mothers within 48 hours after delivery; and blood samples and skin prick test were collected.
Eligibility Criteria
The recruitment of participants was performed in the Sotero del Rio Hospital at Santiago. Women that were obese (BMI\>30) or normal weight (BMI\<25) at their first antenatal visit were invited to participate in the study at the moment of delivery. Questionnaires: Information regarding birth outcomes, maternal and paternal history of asthma and allergy, as well as environmental conditions at home (pet ownership, indoor smoking, heating system, and so on) was collected using a questionnaire at the moment of recruitment. Follow-up questionnaires by phone are completed every 6 months. These questionnaires collect information regarding diagnosis of asthma/allergy and acute respiratory illness, environmental conditions, and relevant confounding variables
You may qualify if:
- Women who receive care in any of the 12 public health care centers in La Florida and Puente Alto and give birth in the Sotero del Río Hospital.
- Singleton pregnancy of fewer than 14 weeks of gestation at the first antenatal visit.
- years or older
You may not qualify if:
- Pregnant women with overweight (BMI 25-30) before 14 weeks.
- Women that have a premature birth, cardio-respiratory disorder or neurological defects of the neonate.
- Women that develop gestational diabetes and hypertension during pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (5)
Castro-Rodriguez JA, Forno E, Casanello P, Padilla O, Krause BJ, Uauy R. Leptin in Cord Blood Associates with Asthma Risk at Age 3 in the Offspring of Women with Gestational Obesity. Ann Am Thorac Soc. 2020 Dec;17(12):1583-1589. doi: 10.1513/AnnalsATS.202001-080OC.
PMID: 32726560RESULTCifuentes-Zuniga F, Arroyo-Jousse V, Soto-Carrasco G, Casanello P, Uauy R, Krause BJ, Castro-Rodriguez JA. IL-10 expression in macrophages from neonates born from obese mothers is suppressed by IL-4 and LPS/INFgamma. J Cell Physiol. 2017 Dec;232(12):3693-3701. doi: 10.1002/jcp.25845. Epub 2017 Apr 27.
PMID: 28160500RESULTVega-Tapia F, Artigas R, Hernandez C, Uauy R, Casanello P, Krause BJ, Castro-Rodriguez JA. Maternal obesity is associated with a sex-specific epigenetic programming in human neonatal monocytes. Epigenomics. 2020 Nov;12(22):1999-2018. doi: 10.2217/epi-2020-0098. Epub 2020 Dec 4.
PMID: 33275450RESULTJaramillo-Ospina A, Castano-Moreno E, Munoz-Munoz E, Krause BJ, Uauy R, Casanello P, Castro-Rodriguez JA. Maternal Obesity Is Associated With Higher Cord Blood Adipokines in Offspring Most Notably in Females. J Pediatr Gastroenterol Nutr. 2021 Aug 1;73(2):264-270. doi: 10.1097/MPG.0000000000003172.
PMID: 34016877RESULTCastro-Rodriguez JA, Forno E, Padilla O, Casanello P, Krause BJ, Borzutzky A. The asthma predictive index as a surrogate diagnostic tool in preschoolers: Analysis of a longitudinal birth cohort. Pediatr Pulmonol. 2021 Oct;56(10):3183-3188. doi: 10.1002/ppul.25592. Epub 2021 Jul 28.
PMID: 34320686RESULT
Biospecimen
Maternal blood sample, cord blood sample and skin prick test.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jose A. Castro-Rodriguez, MD, PhD
Pontificia Universidad Catolica de Chile
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2016
First Posted
September 16, 2016
Study Start
September 1, 2014
Primary Completion
April 1, 2018
Study Completion
June 1, 2018
Last Updated
September 10, 2021
Record last verified: 2018-06
Data Sharing
- IPD Sharing
- Will not share