- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04817878
Cohort Construction for Preterm Infants With Growth Retardation and Its Influencing Factors
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiekontakt
- Navn: chunling huang, Ph.D.
- Telefonnummer: +86 13811485908
- E-post: huangchunling_19@163.com
Studiesteder
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Beijing
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Peking, Beijing, Kina, 100191
- Rekruttering
- Peking University Third Hospital
-
Ta kontakt med:
- chunling huang, Ph.D.
- Telefonnummer: +86 13811485908
- E-post: huangchunling_19@163.con
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
Late preterm infant group
Gestational age 33 weeks-36 weeks
|
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.
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|
Very premature infant group
Gestational age 28 weeks-32 weeks
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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
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Assessment of extrauterine growth retardation of preterm infants at 36-40 weeks of gestational age correction
Tidsramme: 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)
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correct gestational age 36~40 weeks
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Assessment of neurodevelopmental retardation of preterm infants at 36-40 weeks of gestational age correction
Tidsramme: correct gestational age 36~40 weeks
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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.
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correct gestational age 36~40 weeks
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|
Assessment of low weight of preterm infants at 2 to 3 years of age
Tidsramme: 2~3 years old
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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
|
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Assessment of growth retardation of preterm infants at 2 to 3 years of age
Tidsramme: 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
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2~3 years old
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Assessment of small head circumference of preterm infants at 2 to 3 years of age
Tidsramme: 2~3 years old
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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
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2~3 years old
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Assessment of neurodevelopmental retardation of preterm infants at 2 to 3 years of age
Tidsramme: 2~3 years old
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IF the Wechsler intelligence scales score is lower than 70, the child is diagnosed as neurodevelopmental retardation.
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2~3 years old
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: xiaomei tong, Ph.D., Peking University Third Hospital
- Studieleder: yanmei chang, Ph.D., Peking University Third Hospital
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- bysy2020-423-01
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