Clinical trial NCT03668327: Preterm Birth Cohort Study in Guangzhou
Official title: Preterm Birth Cohort Study in Guangzhou
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Preterm Birth
Neurodevelopment
Immune Development
Host and Microbiome
Keywords: Preterm
Cohort
Early development
Child
Lead sponsor: Guangzhou Women and Children's Medical Center
Sponsor class: OTHER
First posted: 2018-09-12
Enrollment: 5000
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population are childrens born before 37 weeks of gestation and their mothers in Guangzhou.

Brief summary: The Preterm Birth Cohort Study in Guangzhou (PBCSG) aims to explore the impact of genetic and environmental factors including life styles on preterm birth, to examine the interaction effect between these factors, and to follow up the short-term and long-term outcomes of preterm childrens.

Detailed description: Preterm birth has become the leading cause of neonatal death and the second leading cause of death among children under five years of age. Preterm childrens are more susceptible to adverse health problems including brain injury and neurodevelopment delay, and are at risk of chronic diseases which could impair the health status and life quality later in life. However, the causes of preterm birth is still not clear, and there are no effective prediction and preventive strategies. The Preterm Birth Cohort Study in Guangzhou (PBCSG) will collect the epidemiological,clinical information and biological specimens including maternal blood,cord blood, placenta, children's blood and stool samples of preterm childrens and their mothers. More importantly, childrens' health status, physical and neurodevelopment will be followed up to late childhood and adolescence. The preterm birth cohort would help to explore the mechanism of preterm birth and to examine the short- and long-term influence of preterm birth on physical health and neurodevelopment of childrens.

Eligibility criteria: Inclusion Criteria:

1. Born before 37 weeks of gestation
2. Born in Guangzhou Women and Children's Medical Center
3. Intended to remain in Guangzhou for more than 3 years

Exclusion Criteria:

1. Multiple birth
2. Stillbirth
3. With major congenital abnormalities

Primary outcomes:
measure: Neurodevelopment at early childhood
timeFrame: At age of 1 year
Secondary outcomes:
measure: Intelligence quotient of offspring
timeFrame: At age of 6 years old
measure: Height changes during childhood and adolescence
timeFrame: At birth, age of 6 weeks, 6 months, 1 year, 3 years, 6 years, 12 years and 18 year
measure: Weight changes during childhood and adolescence
timeFrame: At birth, age of 6 weeks, 6 months, 1 year, 3 years, 6 years, 12 years and 18 year
measure: Change of intestinal flora during early childhood
timeFrame: At age of 6 weeks, 6 months, 1 year, 3 years, 6 years, 12 years and 18 years old
measure: Changes of body fat percentage during early childhood
timeFrame: At age of 3 years, 6 years, 12 years and 18 years old
measure: Changes of bone density during early childhood
timeFrame: At age of 3 years, 6 years, 12 years and 18 years old
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou Women and Children's Medical Center, China
Study officials:
affiliation: Guangzhou Women and Children's Medical Center, China
name: Xiu Qiu, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Qiu X, Lu JH, He JR, Lam KH, Shen SY, Guo Y, Kuang YS, Yuan MY, Qiu L, Chen NN, Lu MS, Li WD, Xing YF, Zhou FJ, Bartington S, Cheng KK, Xia HM. The Born in Guangzhou Cohort Study (BIGCS). Eur J Epidemiol. 2017 Apr;32(4):337-346. doi: 10.1007/s10654-017-0239-x. Epub 2017 Mar 20.