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Clinical Trials/NCT05017389
NCT05017389
Recruiting
N/A

A Cohort Study on the Long-term Health Outcomes of Premature Infants

Shanghai Children's Medical Center1 site in 1 country1,200 target enrollmentJanuary 1, 2021
ConditionsPreterm

Overview

Phase
N/A
Intervention
Not specified
Conditions
Preterm
Sponsor
Shanghai Children's Medical Center
Enrollment
1200
Locations
1
Primary Endpoint
neural development at 1 year old
Status
Recruiting
Last Updated
4 years ago

Overview

Brief 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 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.

Registry
clinicaltrials.gov
Start Date
January 1, 2021
End Date
December 31, 2041
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Shanghai Children's Medical Center
Responsible Party
Principal Investigator
Principal Investigator

BeiFei

director of neonatology department

Shanghai Children's Medical Center

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

Outcomes

Primary Outcomes

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.

Growth and neural development at 18 years old

Time Frame: 18 years

Taking Wechsler Intelligence Scale for 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.

Study Sites (1)

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