Long Term Health Cohort of Premature Infants

Preterm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05017389
• Other study ID #: LY-SCMC2020-01
• Status: Recruiting
• Start date: January 1, 2021
• Est. completion date: December 31, 2041

Study information

• Verified date: July 2021
• Source: Shanghai Children's Medical Center
• Contact: Shumei Dong, master
• Phone: 38626161
• Email: dongshumei[@]scmc.com.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: December 31, 2041
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 4 Months

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Preterm

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
China	Shanghai children's medical center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Children's Medical Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	neural development at 1 year old	Taking Griffiths development scales Chinese Edition test for all the participants.	1 year
Primary	neural development at 2 years old	Taking Griffiths development scales Chinese Edition test for partial participants.	2 years
Primary	neural development at 6 years old	Taking Wechsler Intelligence Scale for participants.	6 years
Primary	Growth and neural development at 12 years old	Taking Wechsler Intelligence Scale for participants.	12 years
Primary	Growth and neural development at 18 years old	Taking Wechsler Intelligence Scale for participants.	18 years