Estudio Del Desarrollo de Los niños Prematuros Nacidos Durante la Pandemia Por el COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 主要终点
- Bayley Scales Of Infant and Toddler Development
研究概览
简要总结
This study aims to evaluate differences in cognitive and psychomotor development among preterm infants (born before 34 weeks of gestation) delivered during the COVID-19 pandemic at Hospital de la Santa Creu i Sant Pau, compared with a control group of preterm infants born at the same hospital.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Other
入排标准
- 年龄范围
- — 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm babies (<34 weeks of gestation) born between March 2020 and December 2021 for case group).
- •Preterm babies (<34 weeks of gestation) born between January 2023 to December 2024 (control group).
- •Babies who were admitted to the NICU of the Hospital de Sant Pau.
- •Babies who were followed up in External Consultations of the same hospital at least until their first year of age.
排除标准
- •Preterm infants ≥34 weeks or preterm born outside the periods described in the inclusion criteria.
- •Concurrent diagnosis of genetic pathology or major malformations.
- •Families who discontinued follow-up or did not attend scheduled appointments.
研究组 & 干预措施
Preterm babies born during the COVID-19 pandemic (2020-21)
干预措施: Evaluation of cognitive and psychomotor development through the Bayley Scales Of Infant and Toddler Development and Wechsler Preschool and Primary Scale of Intelligence (Diagnostic Test)
Preterm babies born after the COVID-19 pandemic (2023-24)
干预措施: Evaluation of cognitive and psychomotor development through the Bayley Scales Of Infant and Toddler Development and Wechsler Preschool and Primary Scale of Intelligence (Diagnostic Test)
结局指标
主要结局
Bayley Scales Of Infant and Toddler Development
时间窗: All scores on this scale will be collected at the following ages for every child: - 3 months - 6 months - 12 months - 18 months - 24 months
It aims to evaluate the child's level of development in different areas. Through structured tasks and materials but in a playful format, it allows to obtain a global score of cognitive, motor and language development. From the direct scores of the scale, it is possible to obtain scalar, composite and percentile scores. The scaled scores are calculated from the direct scores of each test. They have an average of 10 and a standard deviation of 3. They represent the child's performance in relation to children of his same age. The composite scores are typical scores obtained from scales with a mean of 100 and a standard deviation of 15. From these, the corresponding percentiles can be obtained in the tables included in the manual.
Wechsler Preschool and Primary Scale of Intelligence
时间窗: All scores on this scale will be collected at the following ages for every child: - 3 years old - 5 years old
It allows a complete measurement of the subject's cognitive abilities. Through structured tasks, standardized scores are obtained for the overall cognitive capacity, as well as for the verbal, manipulative, processing speed and general language indices. In this study we will collect typical scores, composites and percentiles of each of the subtests and indexes of the Scale. For this, based on the direct scores of each subtest, the typical scores are obtained whose mean is 10 and standard deviation 3. These scores allow inter-individual comparison. On the other hand, with several subtests the composite scores are formed, which correspond to the indices of the WPPSI-III (Verbal CI, Manipulative CI, Processing Speed, General Language and Total CI). The composite scores are converted to a scale of mean 100 and standard deviation of 15. In addition, the WPPSI-III offers percentiles for the scores of the subtests and for the indices.
次要结局
未报告次要终点
研究者
Joana Fernández Miró
Clinical psychologist
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau