Clinical trial NCT04314466: The Effects of Early-life Environmental and Behavioral Factors on Child Growth and Development
Official title: The Effects of Early-life Environmental and Behavioral Factors on Child Growth and Development
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Child Development
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
Collaborators: name: RenJi Hospital
First posted: 2020-03-19
Enrollment: 236
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The prospective cohort study was conducted in the eastern division of the Renji Hospital and Shanghai Children's Medical Center in Pudong New Area, Shanghai, which aimed to explore how the perinatal and early life environmental and behavioral factors affect early child growth and development in a longitudinal and prospective mother-child cohort.

Brief summary: The Shanghai Sleep Birth Cohort Study (SSBC) is a prospective observational study investigating the sleep condition of women in their third trimester and children from the age of 42 days to 6 years. Both subjective and objective tools were used to assess different sleep characteristics, including sleep duration, sleep rhythm and sleep quality. From August 2012 to June 2013, total 277 pregnant women from the eastern division of Renji Hospital in Pudong New Area, Shanghai were included in the study. Demographic information, physical examination, developmental and psychiatric assessment, diet and physical activity, as well as biological samples were collected for further analysis. Main findings of the current study showed the effect of sleep disturbances during the third trimester on emotional regulation and the influence of different sleep characteristics on children's social-emotional development


Eligibility criteria: Inclusion Criteria:

* Long-term resident in Shanghai, and no relocation plan for 2 years
* Ultrasonography indicated singleton pregnancy at 34-36 weeks
* Willingness to participate in the study and engage in the follow-up at the specified time
* Neonates were included if they were partus maturus

Exclusion Criteria:

* Preterm labor symptoms during pregnancy
* Gestational hypertension or gestational diabetes mellitus
* Heart, liver, and kidney disease
* Apgar score was 7 or below at 1 minute or 5 minutes with history of asphyxia at birth

Primary outcomes:
measure: Maternal sleep measured by Pittsburgh Sleep Quality Index(PSQI)
timeFrame: changes from baseline,3 month, 6month, 9month, 12month, 18month, 24 month,36month,48month follow-up
measure: Maternal sleep measured by Actiwatch
timeFrame: baseline
measure: Children sleep measured by Actiwatch
timeFrame: changes from 3 month, 6month, 9month, 12month, 18month, 24 month,36month,48month,72month follow-up
measure: Children sleep measured by Brief Infant Sleep Questionnaire(BISQ)
timeFrame: changes from birth, 42days,3 month, 6month, 9month, 12month, 18month, 24 month,36month follow-up
measure: Children sleep measured by Children's Sleep Habits Questionnaire (CHSQ)
timeFrame: changes from 48month, 72month follow-up
measure: Children weight
timeFrame: changes from birth,42days,3 month, 6month, 9month, 12month, 18month, 24 month,36month,48month,72month follow-up
measure: Children length/height
timeFrame: changes from birth,42days,3 month, 6month, 9month, 12month, 18month, 24 month,36month,48month,72month follow-up
measure: Social-emotion
timeFrame: changes from 36month,48month,72month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai children's medicial center affiliated shanghai jiaotong University School of Medicine
state: Shanghai
Study officials:
References: