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

Anemia Clinical Trial

Official title:

Effect of Antenatal Iron-contained Multiple Micronutrient Supplementation, Cesarean Delivery, and CDMR on Child Health- A Post-trial Follow-up Chinese Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01404416
• Other study ID #: 5119001
• Status: Completed
• Phase: N/A
• First received: July 27, 2011
• Last updated: June 4, 2015
• Start date: May 2011
• Est. completion date: September 2011

Study information

• Verified date: June 2015
• Source: Peking University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Peking University
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17000
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 5 Years

Eligibility

Inclusion Criteria:

• all livebirths

Exclusion Criteria:

• died

• moved out

• refused to participate

• being incapable of participation

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anemia
• Mental Development
• Overweight/Obesity

Locations

Country	Name	City	State
China	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

Sponsors (1)

Lead Sponsor	Collaborator
Peking University

Country where clinical trial is conducted

China,