Long Term Health Cohort of Premature Infants
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Griffiths development scales.
- Who it may be relevant to
- Registry conditions: Preterm. Basic parameters: 15 Days — 4 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Cohort Study on the Long-term Health Outcomes of Premature Infants
Overview
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.
Interventions
- Diagnostic test Griffiths development scales
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.
Primary outcome measures
- neural development at 1 year old [Time frame: 1 year]
- neural development at 2 years old [Time frame: 2 years]
- neural development at 6 years old [Time frame: 6 years]
- Growth and neural development at 12 years old [Time frame: 12 years]
- Growth and neural development at 18 years old [Time frame: 18 years]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Shanghai children's medical center — Shanghai
Identifiers
NCT: NCT05017389 · LY-SCMC2020-01