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NCT Number: NCT05017389

Long Term Health Cohort 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.

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Key information

Conditions

Preterm Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

15 day–4 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai children's medical center

Shanghai, Shanghai Municipality, 200127, China

Location status: Recruiting

Location contact

Xiafang Chen, Ph.D

CONTACT

[email protected]

38626161 ext. 86007

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Griffiths development scales

Diagnostic Test

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.

Other names: Wechsler Intelligence Scale

Primary outcomes

  1. neural development at 1 year old

    Time frame: 1 year

    Taking Griffiths development scales Chinese Edition test for all the participants.

  2. neural development at 2 years old

    Time frame: 2 years

    Taking Griffiths development scales Chinese Edition test for partial participants.

  3. neural development at 6 years old

    Time frame: 6 years

    Taking Wechsler Intelligence Scale for participants.

  4. Growth and neural development at 12 years old

    Time frame: 12 years

    Taking Wechsler Intelligence Scale for participants.

  5. Growth and neural development at 18 years old

    Time frame: 18 years

    Taking Wechsler Intelligence Scale for participants.

Study contacts

Contact information is provided by the study sponsor or research team.

Shumei Dong, master

CONTACT

[email protected]

38626161 ext. 86007

Sponsors and collaborators

Lead sponsor

Shanghai Children's Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2041
First posted
Aug 23, 2021
Registry last updated
Aug 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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