PretermNCT05017389
Long Term Health Cohort of Premature Infants
An observational study of Preterm, run by Shanghai Children's Medical Center at 1 site in China.
Trial summary
Establish a clinical diagnosis and treatment and long-term follow-up database of preterm infants, and analyze the effects of prenatal factors (including genetic characteristics, maternal diseases, etc.), postnatal diagnosis and treatment measures and family maintenance environment after discharge on preterm infant… Read more about this study
- Who is it for?
- Ages 15 days to 4 months
- Conditions the study is for
- Preterm
- What is being tested?
- Griffiths development scales
- How many people
- 1,200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 31 Dec 2041
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 15 days to 4 months
- All sexes
- No healthy volunteers
- Child
Study population: premature infants with gestational age ≤ 36 + 6 weeks.
Who may be able to join
- Live born newborns with gestational age ≤ 36 + 6 weeks
- Transfer to the neonatal ward of Shanghai Children's medical center within 24 hours after birth
- Those who have lived in Shanghai for more than 1 year and plan to live in Shanghai for a long time. Parents voluntarily participated in the study and signed informed consent
Who cannot join
- Premature infants: termination of treatment due to family factors (non-disease reasons) and hospitalization time ≤ 2 weeks
- Major congenital malformations
- Parents refuse to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai children's medical center
Shanghai, Shanghai Municipality, 200127
Xiafang Chen, Ph.D, 38626161 ext. 86007, chxf_1984@hotmail.com
About this study
Official title: A Cohort Study on the Long-term Health Outcomes of Premature Infants
Establish a clinical diagnosis and treatment and long-term follow-up database of preterm infants, and analyze the effects of prenatal factors (including genetic characteristics, maternal diseases, etc.), postnatal diagnosis and treatment measures and family maintenance environment after discharge on preterm infant mortality and major diseases in the near and long term.
Read the detailed description
As an increasing large group, the long-term quality of life and health status of preterm infants have become a very important public health problem in China. This cohort study is a single center clinical cohort study. By collecting the clinical diagnosis, treatment and follow-up data of preterm infants admitted to the neonatal department of our hospital for 3 consecutive years (about 1200 cases), and following them for 18 years, a relatively complete resource database for the long-term health and development of preterm infants is established. The effects of perinatal factors, diagnosis and treatment methods and family rearing environment on the survival rate, neurointelligence development, chronic metabolic diseases and respiratory diseases of preterm infants were analyzed. It provides a basis for further improving the diagnosis and treatment plan, exploring potential therapeutic targets and establishing prediction models.
- Conditions
- Preterm
- Being tested
- Griffiths development scales
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Griffiths development scalesDiagnostic test
Also called Wechsler Intelligence Scale
Griffiths development scales Chinese Edition (gds-c) was used to evaluate the development levels of children up to 6 years and WISC for children more than 6 years.
What is being measured
The primary outcome is the main question the study is designed to answer.
neural development at 1 year old
Taking Griffiths development scales Chinese Edition test for all the participants.
Measured: 1 year
neural development at 2 years old
Taking Griffiths development scales Chinese Edition test for partial participants.
Measured: 2 years
neural development at 6 years old
Taking Wechsler Intelligence Scale for participants.
Measured: 6 years
Growth and neural development at 12 years old
Taking Wechsler Intelligence Scale for participants.
Measured: 12 years
Growth and neural development at 18 years old
Taking Wechsler Intelligence Scale for participants.
Measured: 18 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2021
- Study start1 Jan 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2041 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PretermStudies of the same condition, open and under way.
- 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
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Children's Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BeiFei, Shanghai Children's Medical Center
- Investigators
- Fei Bei, Ph.D, Study chair, Shanghai Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05017389
- Sponsor's protocol ID
- LY-SCMC2020-01
- Status last verified
- Jul 2021
- First submitted
- 27 Jul 2021
- Last updated
- 23 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cohort Study on the Long-term Health Outcomes of Premature Infants
- ClinicalTrials.gov ID
- NCT05017389
- Acronym / sponsor ID
- LY-SCMC2020-01
- Conditions
- Preterm
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Shanghai Children's Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2041 (estimated)
- First posted
- 23 Aug 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.
Establish a clinical diagnosis and treatment and long-term follow-up database of preterm infants, and analyze the effects of prenatal factors (including genetic characteristics, maternal diseases, etc.), postnatal diagnosis and treatment measures and family maintenance environment after discharge on preterm infant mortality and major diseases in the near and long term.
Detailed description
As an increasing large group, the long-term quality of life and health status of preterm infants have become a very important public health problem in China. This cohort study is a single center clinical cohort study. By collecting the clinical diagnosis, treatment and follow-up data of preterm infants admitted to the neonatal department of our hospital for 3 consecutive years (about 1200 cases), and following them for 18 years, a relatively complete resource database for the long-term health and development of preterm infants is established. The effects of perinatal factors, diagnosis and treatment methods and family rearing environment on the survival rate, neurointelligence development, chronic metabolic diseases and respiratory diseases of preterm infants were analyzed. It provides a basis for further improving the diagnosis and treatment plan, exploring potential therapeutic targets and establishing prediction models.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 days to 4 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- premature infants with gestational age ≤ 36 + 6 weeks.
Key inclusion criteria (3 listed)
- Live born newborns with gestational age ≤ 36 + 6 weeks
- Transfer to the neonatal ward of Shanghai Children's medical center within 24 hours after birth
- Those who have lived in Shanghai for more than 1 year and plan to live in Shanghai for a long time. Parents voluntarily participated in the study and signed informed consent
Key exclusion criteria (3 listed)
- Premature infants: termination of treatment due to family factors (non-disease reasons) and hospitalization time ≤ 2 weeks
- Major congenital malformations
- Parents refuse to participate in the study
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 |
|---|---|---|
| Griffiths development scalesAlso: Wechsler Intelligence ScaleGriffiths development scales Chinese Edition (gds-c) was used to evaluate the development levels of children up to 6 years and WISC for children more than 6 years. | Diagnostic test | – |
Primary outcome
neural development at 1 year old
Time frame: 1 year
Taking Griffiths development scales Chinese Edition test for all the participants.
neural development at 2 years old
Time frame: 2 years
Taking Griffiths development scales Chinese Edition test for partial participants.
neural development at 6 years old
Time frame: 6 years
Taking Wechsler Intelligence Scale for participants.
Growth and neural development at 12 years old
Time frame: 12 years
Taking Wechsler Intelligence Scale for participants.
Growth and neural development at 18 years old
Time frame: 18 years
Taking Wechsler Intelligence Scale for participants.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2021.
- Individual participant dataSharing planned: No
Related trials for Preterm
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
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.
Fei Bei, Ph.D study chair
Shanghai Children's Medical Center
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 Preterm, run by Shanghai Children's Medical Center 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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 23 Aug 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shumei Dong, master (38626161 ext. 86007, dongshumei@scmc.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
neural development at 1 year old (time frame: 1 year). The study lists 5 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 23 Aug 2021.