Problem With Growth of an InfantNCT04817878
Cohort Construction for Preterm Infants With Growth Retardation and Its Influencing Factors
An observational study of Problem With Growth of an Infant, run by Peking University Third Hospital at 1 site in China.
Trial summary
In this cohort, prospective clinical cohort study was used to establish a follow-up cohort of preterm infants with different gestational ages. The regular monitoring indexes of physical development and neuropsychological development of preterm infants from birth to 3 years after birth were collected. Read more about this study
- Who is it for?
- Ages 24 to 37 weeks
- Conditions the study is for
- Problem With Growth of an Infant
- What is being tested?
- Developmental assessment
- How many people
- 2,400 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2020to 30 Nov 2023
- How long will I take part?
- 3 Years
- 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 24 to 37 weeks
- All sexes
- No healthy volunteers
- Child
Study population: All preterm infants born during the study period
Who may be able to join
- All preterm infants born less than 37 weeks during the study period
Who cannot join
- Congenital malformations or genetic diseases Various surgical treatments during the newborn period Interrupted treatment or discharged automatically
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
chunling huang, Ph.D., +86 13811485908, huangchunling_19@163.con
About this study
In this cohort, prospective clinical cohort study was used to establish a follow-up cohort of preterm infants with different gestational ages. The regular monitoring indexes of physical development and neuropsychological development of preterm infants from birth to 3 years after birth were collected. The influencing factors of preterm infants' development at different stages were recorded, and the high-risk factors leading to different stages of preterm infants' growth retardation were analyzed.
Read the detailed description
Preterm infants are at high risk of stunting due to premature birth, insufficient intrauterine nutrient reserves, burden of various diseases after birth, and persistent nutrient liabilities. The growth retardation of premature infants at different developmental stages has an important impact on both short-term survival and long-term health. The growth and development data of premature infants during hospitalization and after discharge are very limited in foreign countries. Domestic researches on growth retardation of preterm infants only involve retrospective cross-sectional studies during hospitalization, and lack of prospective follow-up study data on growth and development data of premature infants during hospitalization and after discharge.
In this cohort, prospective clinical cohort study was used to establish a follow-up cohort of preterm infants with different gestational ages. The regular monitoring indexes of physical development and neuropsychological development of preterm infants from birth to 3 years after birth were collected. The influencing factors of preterm infants' development at different stages were recorded, and the high-risk factors leading to different stages of preterm infants' growth retardation were analyzed. In order to provide a strong scientific basis for the development evaluation and intervention of premature infants in China, a systematic and scientific clinical cohort study method was explored to improve the overall medical quality and medical level of the Department and further promote the development of the discipline.
- Conditions
- Problem With Growth of an Infant
- Being tested
- Developmental assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Developmental assessmentCombination product
Physical development assessment (head circumference, length, weight), Neurodevelopment assessment at 36 to 40 weeks of correction (GMS assessment, NBNA assessment), neurodevelopment assessment at 18 months, 24 months, and 36 months (ASQ scale, Language assessment, Wei-style scale), audiovisual screening, etc.
| Study group | Role | What they receive |
|---|---|---|
| Late preterm infant group | Gestational age 33 weeks-36 weeks Receives: Combination Product: Developmental assessment | |
| Very premature infant group | Gestational age 28 weeks-32 weeks Receives: Combination Product: Developmental assessment | |
| Super preterm infant group | Gestational age less than 28 weeks Receives: Combination Product: Developmental assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of extrauterine growth retardation of preterm infants at 36-40 weeks of gestational age correction
According to Fenton 2003 growth curve of premature infants, the weight, length, and head circumference of preterm infants with corrected gestational age of 36-40 weeks were evaluated, If the weight, length and head circumference are lower than the 10th percentile of the corresponding gestational age, the child is diagnosed as EUGR（extrauterine growth retardation）
Measured: correct gestational age 36~40 weeks
Assessment of neurodevelopmental retardation of preterm infants at 36-40 weeks of gestational age correction
IF the NBNA score of preterm infants at 36-40 weeks of correction is lower than 36, and the abnormal GMs is evaluated, the child is diagnosed as neurodevelopmental retardation.
Measured: correct gestational age 36~40 weeks
Assessment of low weight of preterm infants at 2 to 3 years of age
Compared with the same age and gender reference population standard, children's weight below the median minus 2 standard deviations (i.e. less than the 3rd percentile) is diagnosed as low weight
Measured: 2~3 years old
Assessment of growth retardation of preterm infants at 2 to 3 years of age
Compared with the same age and gender reference population standard, children's height below the median minus 2 standard deviations (i.e. less than the 3rd percentile) is diagnosed as growth retardation
Measured: 2~3 years old
Assessment of small head circumference of preterm infants at 2 to 3 years of age
Compared with the same age and gender reference population standard, the children's occipitofrontal circumference (OFC) less than 2 standard deviations (SD) of the mean OFC (i.e. less than the 3rd percentile) is diagnosed as small head circumference
Measured: 2~3 years old
Assessment of neurodevelopmental retardation of preterm infants at 2 to 3 years of age
IF the Wechsler intelligence scales score is lower than 70, the child is diagnosed as neurodevelopmental retardation.
Measured: 2~3 years old
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start1 Dec 2020
- Primary completion30 Nov 2023 (estimated)
- Study completion30 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Problem With Growth of an InfantStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe 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
- 2,400 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaomei Tong, Peking University Third Hospital
- Investigators
- xiaomei tong, Ph.D., Principal investigator, Peking University Third Hospitalyanmei chang, Ph.D., Study director, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04817878
- Sponsor's protocol ID
- bysy2020-423-01
- Status last verified
- Mar 2021
- First submitted
- 16 Mar 2021
- Last updated
- 26 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Construction for Preterm Infants With Growth Retardation and Its Influencing Factors
- ClinicalTrials.gov ID
- NCT04817878
- Acronym / sponsor ID
- bysy2020-423-01
- Conditions
- Problem With Growth of an Infant
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,400 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 26 Mar 2021 (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.
In this cohort, prospective clinical cohort study was used to establish a follow-up cohort of preterm infants with different gestational ages. The regular monitoring indexes of physical development and neuropsychological development of preterm infants from birth to 3 years after birth were collected. The influencing factors of preterm infants' development at different stages were recorded, and the high-risk factors leading to different stages of preterm infants' growth retardation were analyzed.
Detailed description
Preterm infants are at high risk of stunting due to premature birth, insufficient intrauterine nutrient reserves, burden of various diseases after birth, and persistent nutrient liabilities. The growth retardation of premature infants at different developmental stages has an important impact on both short-term survival and long-term health. The growth and development data of premature infants during hospitalization and after discharge are very limited in foreign countries. Domestic researches on growth retardation of preterm infants only involve retrospective cross-sectional studies during hospitalization, and lack of prospective follow-up study data on growth and development data of premature infants during hospitalization and after discharge.
In this cohort, prospective clinical cohort study was used to establish a follow-up cohort of preterm infants with different gestational ages. The regular monitoring indexes of physical development and neuropsychological development of preterm infants from birth to 3 years after birth were collected. The influencing factors of preterm infants' development at different stages were recorded, and the high-risk factors leading to different stages of preterm infants' growth retardation were analyzed. In order to provide a strong scientific basis for the development evaluation and intervention of premature infants in China, a systematic and scientific clinical cohort study method was explored to improve the overall medical quality and medical level of the Department and further promote the development of the discipline.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Late preterm infant group | – | Combination Product: Developmental assessmentGestational age 33 weeks-36 weeks |
| Very premature infant group | – | Combination Product: Developmental assessmentGestational age 28 weeks-32 weeks |
| Super preterm infant group | – | Combination Product: Developmental assessmentGestational age less than 28 weeks |
Who may qualify
- Ages
- 24 to 37 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All preterm infants born during the study period
Key inclusion criteria (1 listed)
- All preterm infants born less than 37 weeks during the study period
Key exclusion criteria (1 listed)
- Congenital malformations or genetic diseases Various surgical treatments during the newborn period Interrupted treatment or discharged automatically
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Developmental assessmentPhysical development assessment (head circumference, length, weight), Neurodevelopment assessment at 36 to 40 weeks of correction (GMS assessment, NBNA assessment), neurodevelopment assessment at 18 months, 24 months, and 36 months (ASQ scale, Language assessment, Wei-style scale), audiovisual screening, etc. | Combination product | Late preterm infant group, Super preterm infant group, Very premature infant group |
Primary outcome
Assessment of extrauterine growth retardation of preterm infants at 36-40 weeks of gestational age correction
Time frame: correct gestational age 36~40 weeks
According to Fenton 2003 growth curve of premature infants, the weight, length, and head circumference of preterm infants with corrected gestational age of 36-40 weeks were evaluated, If the weight, length and head circumference are lower than the 10th percentile of the corresponding gestational age, the child is diagnosed as EUGR（extrauterine growth retardation）
Assessment of neurodevelopmental retardation of preterm infants at 36-40 weeks of gestational age correction
Time frame: correct gestational age 36~40 weeks
IF the NBNA score of preterm infants at 36-40 weeks of correction is lower than 36, and the abnormal GMs is evaluated, the child is diagnosed as neurodevelopmental retardation.
Assessment of low weight of preterm infants at 2 to 3 years of age
Time frame: 2~3 years old
Compared with the same age and gender reference population standard, children's weight below the median minus 2 standard deviations (i.e. less than the 3rd percentile) is diagnosed as low weight
Assessment of growth retardation of preterm infants at 2 to 3 years of age
Time frame: 2~3 years old
Compared with the same age and gender reference population standard, children's height below the median minus 2 standard deviations (i.e. less than the 3rd percentile) is diagnosed as growth retardation
Assessment of small head circumference of preterm infants at 2 to 3 years of age
Time frame: 2~3 years old
Compared with the same age and gender reference population standard, the children's occipitofrontal circumference (OFC) less than 2 standard deviations (SD) of the mean OFC (i.e. less than the 3rd percentile) is diagnosed as small head circumference
Assessment of neurodevelopmental retardation of preterm infants at 2 to 3 years of age
Time frame: 2~3 years old
IF the Wechsler intelligence scales score is lower than 70, the child is diagnosed as neurodevelopmental retardation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2021.
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.
xiaomei tong, Ph.D. principal investigator
Peking University Third Hospital
yanmei chang, Ph.D. study director
Peking University Third Hospital
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 Problem With Growth of an Infant, run by Peking University Third Hospital 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 26 Mar 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact chunling huang, Ph.D. (+86 13811485908, huangchunling_19@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of extrauterine growth retardation of preterm infants at 36-40 weeks of gestational age correction (time frame: correct gestational age 36~40 weeks). The study lists 6 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 26 Mar 2021.