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

• Conditions: Problem With Growth of an Infant
• Interventions: Combination Product: Developmental assessment

• Registration Number: NCT04817878
• Lead Sponsor: Peking University Third Hospital

Brief Summary

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.

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 Timeline

• Study Start: 2020-12-01
• Status Verified: 2021-03
• Study First Submitted: 2021-03-16
• Study First Submitted QC: 2021-03-23
• Last Update Submitted: 2021-03-23
• Study First Posted: 2021-03-26
• Last Update Posted: 2021-03-26
• Primary Completion: 2023-11-30
• Study Completion: 2023-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2400

Inclusion Criteria

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

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Very premature infant group	Developmental assessment	Gestational age 28 weeks-32 weeks
Late preterm infant group	Developmental assessment	Gestational age 33 weeks-36 weeks
Super preterm infant group	Developmental assessment	Gestational age less than 28 weeks

Primary Outcome Measures

Name	Time	Method
Assessment of extrauterine growth retardation of preterm infants at 36-40 weeks of gestational age correction	correct gestational age 36~40 weeks	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）
Assessment of neurodevelopmental retardation of preterm infants at 2 to 3 years of age	2~3 years old	IF the Wechsler intelligence scales score is lower than 70, the child is diagnosed as neurodevelopmental retardation.
Assessment of neurodevelopmental retardation of preterm infants at 36-40 weeks of gestational age correction	correct gestational age 36~40 weeks	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.
Assessment of small head circumference of preterm infants at 2 to 3 years of age	2~3 years old	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
Assessment of low weight of preterm infants at 2 to 3 years of age	2~3 years old	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
Assessment of growth retardation of preterm infants at 2 to 3 years of age	2~3 years old	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

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Peking, Beijing, China