Cohort Construction for Preterm Infants With Growth Retardation and Its Influencing Factors

In this cohort, prospective clinical cohort study was used to establish a follow-up cohort of preterm infants with different gestational ages. The regular monitoring indexes of physical development and neuropsychological development of preterm infants from birth to 3 years after birth were collected. The influencing factors of preterm infants' development at different stages were recorded, and the high-risk factors leading to different stages of preterm infants' growth retardation were analyzed.

Study Overview

• Status: Recruiting
• Conditions: Problem With Growth of an Infant
• Intervention / Treatment: Combination product: Developmental assessment

Detailed Description

Preterm infants are at high risk of stunting due to premature birth, insufficient intrauterine nutrient reserves, burden of various diseases after birth, and persistent nutrient liabilities. The growth retardation of premature infants at different developmental stages has an important impact on both short-term survival and long-term health. The growth and development data of premature infants during hospitalization and after discharge are very limited in foreign countries. Domestic researches on growth retardation of preterm infants only involve retrospective cross-sectional studies during hospitalization, and lack of prospective follow-up study data on growth and development data of premature infants during hospitalization and after discharge.

In this cohort, prospective clinical cohort study was used to establish a follow-up cohort of preterm infants with different gestational ages. The regular monitoring indexes of physical development and neuropsychological development of preterm infants from birth to 3 years after birth were collected. The influencing factors of preterm infants' development at different stages were recorded, and the high-risk factors leading to different stages of preterm infants' growth retardation were analyzed. In order to provide a strong scientific basis for the development evaluation and intervention of premature infants in China, a systematic and scientific clinical cohort study method was explored to improve the overall medical quality and medical level of the Department and further promote the development of the discipline.

• Study Type: Observational
• Enrollment (Anticipated): 2400

Contacts and Locations

• Study Contact: Name: chunling huang, Ph.D.; Phone Number: +86 13811485908; Email: huangchunling_19@163.com

Study Locations

• China
  • Beijing
    • Peking, Beijing, China, 100191
      • Recruiting
      • Peking University Third Hospital
      • Contact: chunling huang, Ph.D.; Phone Number: +86 13811485908; Email: huangchunling_19@163.con

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 months to 8 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All preterm infants born during the study period

Description

Inclusion Criteria:

• All preterm infants born less than 37 weeks during the study period

Exclusion Criteria:

• Congenital malformations or genetic diseases Various surgical treatments during the newborn period Interrupted treatment or discharged automatically

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Late preterm infant group; Gestational age 33 weeks-36 weeks	Combination product: Developmental assessment; Physical development assessment (head circumference, length, weight), Neurodevelopment assessment at 36 to 40 weeks of correction (GMS assessment, NBNA assessment), neurodevelopment assessment at 18 months, 24 months, and 36 months (ASQ scale, Language assessment, Wei-style scale), audiovisual screening, etc.
Very premature infant group; Gestational age 28 weeks-32 weeks	Combination product: Developmental assessment; Physical development assessment (head circumference, length, weight), Neurodevelopment assessment at 36 to 40 weeks of correction (GMS assessment, NBNA assessment), neurodevelopment assessment at 18 months, 24 months, and 36 months (ASQ scale, Language assessment, Wei-style scale), audiovisual screening, etc.
Super preterm infant group; Gestational age less than 28 weeks	Combination product: Developmental assessment; Physical development assessment (head circumference, length, weight), Neurodevelopment assessment at 36 to 40 weeks of correction (GMS assessment, NBNA assessment), neurodevelopment assessment at 18 months, 24 months, and 36 months (ASQ scale, Language assessment, Wei-style scale), audiovisual screening, etc.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of extrauterine growth retardation of preterm infants at 36-40 weeks of gestational age correction	According to Fenton 2003 growth curve of premature infants, the weight, length, and head circumference of preterm infants with corrected gestational age of 36-40 weeks were evaluated, If the weight, length and head circumference are lower than the 10th percentile of the corresponding gestational age, the child is diagnosed as EUGR（extrauterine growth retardation）	correct gestational age 36~40 weeks
Assessment of neurodevelopmental retardation of preterm infants at 36-40 weeks of gestational age correction	IF the NBNA score of preterm infants at 36-40 weeks of correction is lower than 36, and the abnormal GMs is evaluated, the child is diagnosed as neurodevelopmental retardation.	correct gestational age 36~40 weeks
Assessment of low weight of preterm infants at 2 to 3 years of age	Compared with the same age and gender reference population standard, children's weight below the median minus 2 standard deviations (i.e. less than the 3rd percentile) is diagnosed as low weight	2~3 years old
Assessment of growth retardation of preterm infants at 2 to 3 years of age	Compared with the same age and gender reference population standard, children's height below the median minus 2 standard deviations (i.e. less than the 3rd percentile) is diagnosed as growth retardation	2~3 years old
Assessment of small head circumference of preterm infants at 2 to 3 years of age	Compared with the same age and gender reference population standard, the children's occipitofrontal circumference (OFC) less than 2 standard deviations (SD) of the mean OFC (i.e. less than the 3rd percentile) is diagnosed as small head circumference	2~3 years old
Assessment of neurodevelopmental retardation of preterm infants at 2 to 3 years of age	IF the Wechsler intelligence scales score is lower than 70, the child is diagnosed as neurodevelopmental retardation.	2~3 years old

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Investigators: Principal Investigator: xiaomei tong, Ph.D., Peking University Third Hospital; Study Director: yanmei chang, Ph.D., Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Anticipated): November 30, 2023
• Study Completion (Anticipated): November 30, 2023

Study Registration Dates

• First Submitted: March 16, 2021
• First Submitted That Met QC Criteria: March 23, 2021
• First Posted (Actual): March 26, 2021

Study Record Updates

• Last Update Posted (Actual): March 26, 2021
• Last Update Submitted That Met QC Criteria: March 23, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: bysy2020-423-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No