Effect of Antenatal Iron-contained Multiple Micronutrient Supplementation, Cesarean Delivery, and CDMR on Child Health
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| ClinicalTrials.gov Identifier: NCT01404416 |
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Recruitment Status
:
Completed
First Posted
: July 28, 2011
Last Update Posted
: June 8, 2015
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Sponsor:
Peking University
Information provided by (Responsible Party):
Liu Jianmeng, Peking University
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Brief 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.
| Condition or disease |
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| Overweight/Obesity Anemia Mental Development |
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.
| Study Type : | Observational |
| Actual Enrollment : | 17000 participants |
| 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 |
| Study Start Date : | May 2011 |
| Actual Primary Completion Date : | September 2011 |
| Actual Study Completion Date : | September 2011 |
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| Ages Eligible for Study: | 1 Year to 5 Years (Child) |
| Sexes Eligible for Study: | All |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
| Responsible Party: | Liu Jianmeng, Institute of Reproductive and Child Health, Peking University |
| ClinicalTrials.gov Identifier: | NCT01404416 History of Changes |
| Other Study ID Numbers: |
5119001 |
| First Posted: | July 28, 2011 Key Record Dates |
| Last Update Posted: | June 8, 2015 |
| Last Verified: | June 2015 |
Additional relevant MeSH terms:
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Overweight Body Weight Signs and Symptoms Micronutrients |
Trace Elements Growth Substances Physiological Effects of Drugs |