Long Term Health Cohort of Premature Infants

NCT ID: NCT05017389

Last Updated: 2021-08-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-01

Study Completion Date

2041-12-31

Brief Summary

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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

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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

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Preterm

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Wechsler Intelligence Scale

Eligibility Criteria

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Inclusion Criteria

1. Live born newborns with gestational age ≤ 36 + 6 weeks
2. Transfer to the neonatal ward of Shanghai Children's medical center within 24 hours after birth
3. 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

1. Premature infants: termination of treatment due to family factors (non-disease reasons) and hospitalization time ≤ 2 weeks
2. Major congenital malformations
3. Parents refuse to participate in the study
Minimum Eligible Age

15 Days

Maximum Eligible Age

4 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Children's Medical Center

OTHER

Sponsor Role lead

Responsible Party

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BeiFei

director of neonatology department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fei Bei, Ph.D

Role: STUDY_CHAIR

Shanghai Children's Medical Center

Locations

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Shanghai children's medical center

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Shumei Dong, master

Role: CONTACT

38626161 ext. 86007

Facility Contacts

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Xiafang Chen, Ph.D

Role: primary

38626161 ext. 86007

Other Identifiers

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LY-SCMC2020-01

Identifier Type: -

Identifier Source: org_study_id

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