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

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ClinicalTrials.gov Identifier: NCT04817878
Recruitment Status : Recruiting
First Posted : March 26, 2021
Last Update Posted : March 26, 2021
Sponsor:
Information provided by (Responsible Party):
Xiaomei Tong, Peking University Third Hospital

Study Description
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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.

Condition or disease Intervention/treatment
Problem With Growth of an Infant 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 Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 2400 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Cohort Construction for Preterm Infants With Growth Retardation and Its Influencing Factors
Actual Study Start Date : December 1, 2020
Estimated Primary Completion Date : November 30, 2023
Estimated Study Completion Date : November 30, 2023
Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Assessment of extrauterine growth retardation of preterm infants at 36-40 weeks of gestational age correction [ Time Frame: 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）

  2. Assessment of neurodevelopmental retardation of preterm infants at 36-40 weeks of gestational age correction [ Time Frame: 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.

  3. Assessment of low weight of preterm infants at 2 to 3 years of age [ Time Frame: 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

  4. Assessment of growth retardation of preterm infants at 2 to 3 years of age [ Time Frame: 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

  5. Assessment of small head circumference of preterm infants at 2 to 3 years of age [ Time Frame: 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

  6. Assessment of neurodevelopmental retardation of preterm infants at 2 to 3 years of age [ Time Frame: 2~3 years old ]
    IF the Wechsler intelligence scales score is lower than 70, the child is diagnosed as neurodevelopmental retardation.


Biospecimen Retention:   Samples Without DNA
Blood routine， Convenience routine

Eligibility Criteria
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Ages Eligible for Study:   24 Weeks to 37 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All preterm infants born during the study period
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04817878


Contacts
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Contact: chunling huang, Ph.D. +86 13811485908 huangchunling_19@163.com

Locations
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China, Beijing
Peking University Third Hospital Recruiting
Peking, Beijing, China, 100191
Contact: chunling huang, Ph.D.    +86 13811485908    huangchunling_19@163.con   
Sponsors and Collaborators
Peking University Third Hospital
Investigators
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Principal Investigator: xiaomei tong, Ph.D. Peking University Third Hospital
Study Director: yanmei chang, Ph.D. Peking University Third Hospital
More Information
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Responsible Party: Xiaomei Tong, Director, Head of peadiatrics, Clinical Professor, Peking University Third Hospital
ClinicalTrials.gov Identifier: NCT04817878    
Other Study ID Numbers: bysy2020-423-01
First Posted: March 26, 2021    Key Record Dates
Last Update Posted: March 26, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No