NCT01404416

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
17,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2011

Shorter than P25 for all trials

Geographic Reach
1 country

5 active sites

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

May 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 27, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 28, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

June 8, 2015

Status Verified

June 1, 2015

Enrollment Period

4 months

First QC Date

July 27, 2011

Last Update Submit

June 4, 2015

Conditions

Eligibility Criteria

Age1 Year - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability 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.

You may qualify if:

  • all livebirths

You may not qualify if:

  • died
  • moved out
  • refused to participate
  • being incapable of participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Mancheng Maternal and Child Health Hospital

Baoding, Hebei, China

Location

Xianghe Maternal and Child Health Hospital

Langfang, Hebei, China

Location

Yuanshi Maternal and Child Health Hospital

Shijiazhuang, Hebei, China

Location

Fengrun Maternal and Child Health Hospital

Tangshan, Hebei, China

Location

Laoting Maternal and Child Health Hospital

Tangshan, Hebei, China

Location

Related Publications (1)

  • Si KY, Li HT, Zhou YB, Li ZW, Zhang L, Zhang YL, Ye RW, Liu JM. Cesarean delivery on maternal request and common child health outcomes: A prospective cohort study in China. J Glob Health. 2022 Feb 26;12:11001. doi: 10.7189/jogh.12.11001. eCollection 2022.

MeSH Terms

Conditions

OverweightObesityAnemia

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHematologic DiseasesHemic and Lymphatic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Institute of Reproductive and Child Health

Study Record Dates

First Submitted

July 27, 2011

First Posted

July 28, 2011

Study Start

May 1, 2011

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

June 8, 2015

Record last verified: 2015-06

Locations