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

23. mars 2021 oppdatert av: Xiaomei Tong, Peking University Third Hospital
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.

Studieoversikt

Status

Rekruttering

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

Observasjonsmessig

Registrering (Forventet)

2400

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

    • Beijing
      • Peking, Beijing, Kina, 100191
        • Rekruttering
        • Peking University Third Hospital
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

5 måneder til 8 måneder (Barn)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

All preterm infants born during the study period

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

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.
Very premature infant group
Gestational age 28 weeks-32 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.
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)
correct gestational age 36~40 weeks
Assessment of neurodevelopmental retardation of preterm infants at 36-40 weeks of gestational age correction
Tidsramme: 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.
correct gestational age 36~40 weeks
Assessment of low weight 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 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
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
2~3 years old
Assessment of small head circumference 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, 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
Tidsramme: 2~3 years old
IF the Wechsler intelligence scales score is lower than 70, the child is diagnosed as neurodevelopmental retardation.
2~3 years old

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: xiaomei tong, Ph.D., Peking University Third Hospital
  • Studieleder: yanmei chang, Ph.D., Peking University Third Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. desember 2020

Primær fullføring (Forventet)

30. november 2023

Studiet fullført (Forventet)

30. november 2023

Datoer for studieregistrering

Først innsendt

16. mars 2021

Først innsendt som oppfylte QC-kriteriene

23. mars 2021

Først lagt ut (Faktiske)

26. mars 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

26. mars 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

23. mars 2021

Sist bekreftet

1. mars 2021

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • bysy2020-423-01

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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