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Long Term Health Cohort of Premature Infants

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05017389
Enrollment
1200
Registered
2021-08-23
Start date
2021-01-01
Completion date
2041-12-31
Last updated
2021-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm

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.

Interventions

DIAGNOSTIC_TESTGriffiths 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.

Sponsors

Shanghai Children's Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
15 Days to 4 Months
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
neural development at 1 year old1 yearTaking Griffiths development scales Chinese Edition test for all the participants.
neural development at 2 years old2 yearsTaking Griffiths development scales Chinese Edition test for partial participants.
neural development at 6 years old6 yearsTaking Wechsler Intelligence Scale for participants.
Growth and neural development at 12 years old12 yearsTaking Wechsler Intelligence Scale for participants.
Growth and neural development at 18 years old18 yearsTaking Wechsler Intelligence Scale for participants.

Countries

China

Contacts

Primary ContactShumei Dong, master
dongshumei@scmc.com.cn38626161

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026