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

23 de marzo de 2021 actualizado por: 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.

Descripción general del estudio

Estado

Reclutamiento

Descripción detallada

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.

Tipo de estudio

De observación

Inscripción (Anticipado)

2400

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

    • Beijing
      • Peking, Beijing, Porcelana, 100191
        • Reclutamiento
        • Peking University Third Hospital
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

5 meses a 8 meses (Niño)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra de probabilidad

Población de estudio

All preterm infants born during the study period

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Assessment of extrauterine growth retardation of preterm infants at 36-40 weeks of gestational age correction
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: xiaomei tong, Ph.D., Peking University Third Hospital
  • Director de estudio: yanmei chang, Ph.D., Peking University Third Hospital

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de diciembre de 2020

Finalización primaria (Anticipado)

30 de noviembre de 2023

Finalización del estudio (Anticipado)

30 de noviembre de 2023

Fechas de registro del estudio

Enviado por primera vez

16 de marzo de 2021

Primero enviado que cumplió con los criterios de control de calidad

23 de marzo de 2021

Publicado por primera vez (Actual)

26 de marzo de 2021

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

26 de marzo de 2021

Última actualización enviada que cumplió con los criterios de control de calidad

23 de marzo de 2021

Última verificación

1 de marzo de 2021

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • bysy2020-423-01

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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