Child DevelopmentSSBCNCT04314466
The Effects of Early-life Environmental and Behavioral Factors on Child Growth and Development
An observational study of Child Development, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Child Development
- How many people
- 236 participants
- Where
- 1 siteChina
- Study dates
- 20 May 2012to Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai children's medicial center affiliated shanghai jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 2000127
About this study
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
- Conditions
- Child Development
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal sleep measured by Pittsburgh Sleep Quality Index(PSQI)
The PSQI total score represents the sum of component scores for subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, use of sleep medicine, and daytime dysfunction. A PSQI score >5 defined poor sleep quality. Higher scores implied lower sleep quality or more severe sleep disturbance.
Measured: changes from baseline,3 month, 6month, 9month, 12month, 18month, 24 month,36month,48month follow-up
Maternal sleep measured by Actiwatch
Sleep assessment was a major part of the study. A 7-day assessment of mothers' sleep quality was conducted during the third trimester by using Actiwatch (Respironics, Inc.1001, Actiwatch 2) and sleep diary. Actiwatch is a sleep assessment system based on monitoring individual activity whose evaluation point is based on the sleep diary.
Measured: baseline
Children sleep measured by Actiwatch
Sleep assessment was a major part of the study. A 7-day assessment of mothers' sleep quality was conducted during the third trimester by using Actiwatch (Respironics, Inc.1001, Actiwatch 2) and sleep diary. Actiwatch is a sleep assessment system based on monitoring individual activity whose evaluation point is based on the sleep diary.
Measured: changes from 3 month, 6month, 9month, 12month, 18month, 24 month,36month,48month,72month follow-up
Children sleep measured by Brief Infant Sleep Questionnaire(BISQ)
Infant sleep problems reported by the mother and according to Brief Infant Sleep Questionnaire (BISQ). It is not a scale. The variables of the questionnaire included 1) nocturnal sleep duration (between the hours of 7 pm and 7 am); 2) daytime sleep duration (between the hours of 7 am and 7 pm); 3) number of night wakenings; 4) duration of wakefulness during the night hours (10 pm to 6 am); 5) nocturnal sleep-onset time (the time when the child falls asleep for the night); 6) settling time (latency to falling asleep for the night); 7) method of falling asleep; 8) location of sleep; 9) preferred body position; 10) age of child; 11) gender of child; 12) birth order; and 13) role of the responder who completed the BISQ. If the child woke up more than 3 times per night, spent more than 1 hour in wakefulness during the night, or spent less than 9 hours in sleep (day and night), then they were considered as poor sleepers.
Measured: changes from birth, 42days,3 month, 6month, 9month, 12month, 18month, 24 month,36month follow-up
Children sleep measured by Children's Sleep Habits Questionnaire (CHSQ)
Children's Sleep Habits Questionnaire (CHSQ) Sleep onset and wake up time in the past weekdays and weekends were collected from a parent reported Children Sleep Habits Questionnaire23 and sleep duration in weekdays and weekends was calculated separately. Daily average sleep duration was calculated using the formula: ([weekday sleep duration×5] + [weekend sleep duration×2])/7.
Measured: changes from 48month, 72month follow-up
Children weight
Child weight were obtained at each visit. Weight was measured using calibrated scales (birth to 24 months, Seca 335, Hamburg, Germany) and electronic personal scale (3-4 years, Seca 877, Hamburg, Germany).
Measured: changes from birth,42days,3 month, 6month, 9month, 12month, 18month, 24 month,36month,48month,72month follow-up
Children length/height
Child length/height were obtained at each visit.Recumbent length (birth to 24 months) was measured from the top of the head to the soles of feet using the same calibrated scale as weight. Standing height (2-4 years) was measured using a stadiometer (Seca 206, Hamburg, Germany) from the top of children's head to his or her heels.
Measured: changes from birth,42days,3 month, 6month, 9month, 12month, 18month, 24 month,36month,48month,72month follow-up
Social-emotion
The Strengths and Difficulties Questionnaire (SDQ) we use in this survey is a short screening questionnaire covering the current difficulties in social psychology (i.e. emotional symptoms, conduct problems, hyperactivity-inattention, peer problems), and personal strengths (i.e. prosocial behavior). High SDQ score is associated with an increase in psychiatric risk, on the opposite, prosocial behavior score is positive with prosocial behavior.
Measured: changes from 36month,48month,72month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2020
- Study start20 May 2012
- Primary completion12 Sep 2013
- Study completionJan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child DevelopmentStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 236 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- RenJi Hospital
- Responsible party
- Principal investigator, Sijia Gu, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04314466
- Sponsor's protocol ID
- SCMCIRB-2012033
- Acronym
- SSBC
- Status last verified
- Mar 2020
- First submitted
- 11 Mar 2020
- Last updated
- 19 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Early-life Environmental and Behavioral Factors on Child Growth and Development
- ClinicalTrials.gov ID
- NCT04314466
- Acronym / sponsor ID
- SSBC / SCMCIRB-2012033
- Conditions
- Child Development
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Collaborators
- RenJi Hospital
- Study start
- 20 May 2012 (actual)
- Primary completion
- 12 Sep 2013 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 19 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Maternal sleep measured by Pittsburgh Sleep Quality Index(PSQI)
Time frame: changes from baseline,3 month, 6month, 9month, 12month, 18month, 24 month,36month,48month follow-up
The PSQI total score represents the sum of component scores for subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, use of sleep medicine, and daytime dysfunction. A PSQI score >5 defined poor sleep quality. Higher scores implied lower sleep quality or more severe sleep disturbance.
Maternal sleep measured by Actiwatch
Time frame: baseline
Sleep assessment was a major part of the study. A 7-day assessment of mothers' sleep quality was conducted during the third trimester by using Actiwatch (Respironics, Inc.1001, Actiwatch 2) and sleep diary. Actiwatch is a sleep assessment system based on monitoring individual activity whose evaluation point is based on the sleep diary.
Children sleep measured by Actiwatch
Time frame: changes from 3 month, 6month, 9month, 12month, 18month, 24 month,36month,48month,72month follow-up
Sleep assessment was a major part of the study. A 7-day assessment of mothers' sleep quality was conducted during the third trimester by using Actiwatch (Respironics, Inc.1001, Actiwatch 2) and sleep diary. Actiwatch is a sleep assessment system based on monitoring individual activity whose evaluation point is based on the sleep diary.
Children sleep measured by Brief Infant Sleep Questionnaire(BISQ)
Time frame: changes from birth, 42days,3 month, 6month, 9month, 12month, 18month, 24 month,36month follow-up
Infant sleep problems reported by the mother and according to Brief Infant Sleep Questionnaire (BISQ). It is not a scale. The variables of the questionnaire included 1) nocturnal sleep duration (between the hours of 7 pm and 7 am); 2) daytime sleep duration (between the hours of 7 am and 7 pm); 3) number of night wakenings; 4) duration of wakefulness during the night hours (10 pm to 6 am); 5) nocturnal sleep-onset time (the time when the child falls asleep for the night); 6) settling time (latency to falling asleep for the night); 7) method of falling asleep; 8) location of sleep; 9) preferred body position; 10) age of child; 11) gender of child; 12) birth order; and 13) role of the responder who completed the BISQ. If the child woke up more than 3 times per night, spent more than 1 hour in wakefulness during the night, or spent less than 9 hours in sleep (day and night), then they were considered as poor sleepers.
Children sleep measured by Children's Sleep Habits Questionnaire (CHSQ)
Time frame: changes from 48month, 72month follow-up
Children's Sleep Habits Questionnaire (CHSQ) Sleep onset and wake up time in the past weekdays and weekends were collected from a parent reported Children Sleep Habits Questionnaire23 and sleep duration in weekdays and weekends was calculated separately. Daily average sleep duration was calculated using the formula: ([weekday sleep duration×5] + [weekend sleep duration×2])/7.
Children weight
Time frame: changes from birth,42days,3 month, 6month, 9month, 12month, 18month, 24 month,36month,48month,72month follow-up
Child weight were obtained at each visit. Weight was measured using calibrated scales (birth to 24 months, Seca 335, Hamburg, Germany) and electronic personal scale (3-4 years, Seca 877, Hamburg, Germany).
Children length/height
Time frame: changes from birth,42days,3 month, 6month, 9month, 12month, 18month, 24 month,36month,48month,72month follow-up
Child length/height were obtained at each visit.Recumbent length (birth to 24 months) was measured from the top of the head to the soles of feet using the same calibrated scale as weight. Standing height (2-4 years) was measured using a stadiometer (Seca 206, Hamburg, Germany) from the top of children's head to his or her heels.
Social-emotion
Time frame: changes from 36month,48month,72month follow-up
The Strengths and Difficulties Questionnaire (SDQ) we use in this survey is a short screening questionnaire covering the current difficulties in social psychology (i.e. emotional symptoms, conduct problems, hyperactivity-inattention, peer problems), and personal strengths (i.e. prosocial behavior). High SDQ score is associated with an increase in psychiatric risk, on the opposite, prosocial behavior score is positive with prosocial behavior.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Child Development, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal sleep measured by Pittsburgh Sleep Quality Index(PSQI) (time frame: changes from baseline,3 month, 6month, 9month, 12month, 18month, 24 month,36month,48month follow-up). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2020.