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CompletedNCT02903134Updated Sep 10, 2021

Early Risk of Asthma in Children Exposed to In-utero Maternal Obesity

An observational study in Asthma, Children and Obesity, sponsored by Pontificia Universidad Catolica de Chile. Completed. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2021-09-10.

Sponsored by Pontificia Universidad Catolica de Chile · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
240
Ages
18 Years to 45 Years
Sex
Female
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Study 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.

Read the detailed description

The general objectives of this study are:

  1. To determine whether the increased risk of asthma in children born from a pre-pregnant obese mother can be observed at 3 years of life and whether this increased risk associated with altered plasma levels of immune mediators at birth.
  2. To explore in children born from pre-pregnant obese mother whether monocyte physiology and M1-M2 polarization present an altered response and expression of asthma-related immune-modulations at birth.
  3. To study in neonates born from pre-pregnant obese mother whether the in vitro expression of TNFα, IL12, IL-10 and IL-4Rα in monocytes associates with changes in the DNA methylation status in the promoter regions of those genes.

The study is performed in accordance with the Helsinki Declaration, and the study protocol was accepted by Institutional Review Boards at School of Medicine of the Pontificia Universidad Católica de Chile.

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Conditions studied

  • Asthma
  • Children
  • Obesity
  • Maternal
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In context

Asthma

3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.

This study's enrollment of 240 is above the median of 150 across 970 observational studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

Pontificia Universidad Catolica de Chile is the lead sponsor of 215 studies on the registry; 56 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

  • 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.
  • 18 years or older

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
240 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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.

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What researchers measure

Primary outcomes

  1. Risk of asthma (defined as "positive asthma predictive index" at 36 months of age)

    Time frame: 36 months of age

Secondary outcomes

  1. Allergy status (positive skin prick test)

    Time frame: 30-36 months of age

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 32726560 ↗
  • Cifuentes-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. PubMed 28160500 ↗
  • Vega-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. PubMed 33275450 ↗
  • Jaramillo-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. PubMed 34016877 ↗
  • Castro-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. PubMed 34320686 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 10, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02903134
Lead sponsor
Pontificia Universidad Catolica de Chile
Responsible party
Sponsor
First posted
Sep 16, 2016
Start date
Sep 2014
Primary completion
Apr 2018
Completion
Jun 2018
Last update
Sep 10, 2021

Study contacts

Jose A. Castro-Rodriguez, MD, PhD
principal investigator · Pontificia Universidad Catolica de Chile

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.

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