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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Peking University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Peking University
ClinicalTrials.gov Identifier:
NCT01404416
First received: July 27, 2011
Last updated: NA
Last verified: July 2011
History: No changes posted
  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:

Study Start Date: May 2011
Estimated Study Completion Date: September 2011
Estimated 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01404416

Contacts
Contact: Jian-meng Liu, PhD 86-10-82801169 liujm@pku.edu.cn
Contact: Hong-tian Li, MD 86-10-82801759 ext 115 liht@pku.edu.cn

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

No publications provided

Responsible Party: Jian-meng Liu, Institute of Reproductive and Child Health, Peking University Health Science Center
ClinicalTrials.gov Identifier: NCT01404416     History of Changes
Other Study ID Numbers: 5119001
Study First Received: July 27, 2011
Last Updated: July 27, 2011
Health Authority: China: Peking University

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms
Micronutrients
Trace Elements
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 20, 2014