Long Term Health Cohort of Premature Infants

NCT05017389 | Recruiting

• 1 other identifier: LY-SCMC2020-01
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm

Outcome Measures

Primary Outcomes (5)

• neural development at 1 year old

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

  1 year

• neural development at 2 years old

  Taking Griffiths development scales Chinese Edition test for partial participants.

  2 years

• neural development at 6 years old

  Taking Wechsler Intelligence Scale for participants.

  6 years

• Growth and neural development at 12 years old

  Taking Wechsler Intelligence Scale for participants.

  12 years

• Growth and neural development at 18 years old

  Taking Wechsler Intelligence Scale for participants.

  18 years

Interventions

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.

Also known as: Wechsler Intelligence Scale

Eligibility Criteria

• Age: 15 Days - 4 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

premature infants with gestational age ≤ 36 + 6 weeks.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Children's Medical Center: lead

Study Sites (1)

Shanghai children's medical center

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Take 2-5ml blood samples for relevant biochemical tests

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Fei Bei, Ph.D

  Shanghai Children's Medical Center

  STUDY CHAIR

Central Study Contacts

Shumei Dong, master

CONTACT

38626161; dongshumei@scmc.com.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director of neonatology department

Study Record Dates

• First Submitted: July 27, 2021
• First Posted: August 23, 2021
• Study Start: January 1, 2021
• Primary Completion: December 31, 2023
• Study Completion (Estimated): December 31, 2041
• Last Updated: August 23, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)