Effect of Antenatal Iron-contained Multiple Micronutrient Supplementation, Cesarean Delivery, and CDMR on Child Health

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Liu Jianmeng, Peking University
ClinicalTrials.gov Identifier:
NCT01404416
First received: July 27, 2011
Last updated: June 4, 2015
Last verified: June 2015
  Purpose

The follow-up study was based on our previous nutritional intervention trial entitled "Impact of Prenatal Vitamin/Mineral Supplements on Perinatal Mortality (NCT00133744)". We followed up all livebirths born to women of the trial to measure their height, weight, and hemoglobin and to implement a questionaire survey (including developmental milestones, disease history, breast feeding, passive smoking, et al). We selected a sub-sample of infants to assess their IQ, emotional and behavioral problem, and language development status. The outcomes of interest include death, body mass index, overweight/ obesity, stunting/ wasting/ thinness, anemia, developmental milestones, IQ, emotional and behavioral disorder, language developmental status, and disease history. Other interesting exposure includes breast feeding, passive smoking, et al. We hypothesize that intrauterine nutritional exposure has an impact on offspring's physical, mental, and language development. We also hypothesize that cesarean delivery including CDMR has an impact on offspring's these outcomes.


Condition
Overweight/Obesity
Anemia
Mental Development

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of Antenatal Iron-contained Multiple Micronutrient Supplementation, Cesarean Delivery, and CDMR on Child Health- A Post-trial Follow-up Chinese Study

Resource links provided by NLM:


Further study details as provided by Peking University:

Enrollment: 17000
Study Start Date: May 2011
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Detailed Description:

The follow-up study was based on our previous nutritional intervention trial entitled "Impact of Prenatal Vitamin/Mineral Supplements on Perinatal Mortality (NCT00133744)". We followed up all livebirths born to women of the trial to measure their height, weight, and hemoglobin and to implement a questionaire survey (including developmental milestones, disease history, breast feeding, passive smoking, et al). We selected 1200 <30 months infants to assess their IQ with Bayley scale, emotional and behavioral problem with CBCL scale, and language development status with LDS scale. We also selected 1500 >30 months children to measure their emotional and behavioral problem with CBCL scale. The exposure groups include intrauterine nutritional exposure and cesarean delivery exposure as well as CDMR. The outcomes of interest include death, body mass index, overweight/ obesity, stunting/ wasting/ thinness, anemia, developmental milestones, IQ, emotional and behavioral disorder, language developmental status, and disease history. Other interesting exposure includes breast feeding, passive smoking, et al. We hypothesize that intrauterine nutritional exposure has an impact on offspring's physical, mental, and language development. We also hypothesize that cesarean delivery including CDMR has an impact on offspring's these outcomes.

  Eligibility

Ages Eligible for Study:   1 Year to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

all livebirths born to women of our previous trial (NCT00133744) who were from Laoting, Fengrun, Xianghe, Mancheng, and Yuanshi counties of China.

Criteria

Inclusion Criteria:

  • all livebirths

Exclusion Criteria:

  • died
  • moved out
  • refused to participate
  • being incapable of participation
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01404416

Locations
China, Hebei
Mancheng Maternal and Child Health Hospital
Baoding, Hebei, China
Xianghe Maternal and Child Health Hospital
Langfang, Hebei, China
Yuanshi Maternal and Child Health Hospital
Shijiazhuang, Hebei, China
Fengrun Maternal and Child Health Hospital
Tangshan, Hebei, China
Laoting Maternal and Child Health Hospital
Tangshan, Hebei, China
Sponsors and Collaborators
Peking University
  More Information

No publications provided

Responsible Party: Liu Jianmeng, Institute of Reproductive and Child Health, Peking University
ClinicalTrials.gov Identifier: NCT01404416     History of Changes
Other Study ID Numbers: 5119001
Study First Received: July 27, 2011
Last Updated: June 4, 2015
Health Authority: China: Peking University

Additional relevant MeSH terms:
Micronutrients
Trace Elements
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 30, 2015