NCT02903134

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

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2014

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

September 10, 2021

Status Verified

June 1, 2018

Enrollment Period

3.6 years

First QC Date

September 13, 2016

Last Update Submit

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

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-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

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.

  • 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.

  • 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.

  • 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.

  • 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.

Biospecimen

Retention: SAMPLES WITH DNA

Maternal blood sample, cord blood sample and skin prick test.

MeSH Terms

Conditions

AsthmaObesity

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jose A. Castro-Rodriguez, MD, PhD

    Pontificia Universidad Catolica de Chile

    PRINCIPAL INVESTIGATOR

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