Clinical trial NCT04817878: Cohort Construction for Preterm Infants With Growth Retardation and Its Influencing Factors
Official title: Cohort Construction for Preterm Infants With Growth Retardation and Its Influencing Factors
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Problem With Growth of an Infant
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-03-26
Enrollment: 2400
Sex: ALL
Minimum age (years): 24
Maximum age (years): 37
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All preterm infants born during the study period

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.

Eligibility criteria: 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

Primary outcomes:
measure: Assessment of extrauterine growth retardation of preterm infants at 36-40 weeks of gestational age correction
timeFrame: correct gestational age 36~40 weeks
measure: Assessment of neurodevelopmental retardation of preterm infants at 36-40 weeks of gestational age correction
timeFrame: correct gestational age 36~40 weeks
measure: Assessment of low weight of preterm infants at 2 to 3 years of age
timeFrame: 2~3 years old
measure: Assessment of growth retardation of preterm infants at 2 to 3 years of age
timeFrame: 2~3 years old
measure: Assessment of small head circumference of preterm infants at 2 to 3 years of age
timeFrame: 2~3 years old
measure: Assessment of neurodevelopmental retardation of preterm infants at 2 to 3 years of age
timeFrame: 2~3 years old
Secondary outcomes:
Other outcomes:
Locations:
city: Peking
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: xiaomei tong, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University Third Hospital
name: yanmei chang, Ph.D.
role: STUDY_DIRECTOR
References: