Development of Preterm Infants Born During the COVID-19 Pandemic
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 5
SponsorFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Preterm infants (born before 34 weeks of gestation), born from March 2020 to December 2021 (case group) and preterm infants (born before 34 weeks of gestation), born from January 2023 to December 2024 (control group). All those who have entered the NICU of Hospital de Sant Pau and follow up in external consultations.
Trial design
Design model
Case-control
Time perspective
Other
Treatments tested in this trial
Evaluation of cognitive and psychomotor development through the Bayley Scales Of Infant and Toddler Development and Wechsler Preschool and Primary Scale of Intelligence
Diagnostic testComparative and longitudinal study of development
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Preterm babies born during the COVID-19 pandemic (2020-21)1 intervention
Group B: Preterm babies born after the COVID-19 pandemic (2023-24)1 intervention
Trial outcomes
Primary outcomes
1
Bayley Scales Of Infant and Toddler Development
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.
Time frame
All scores on this scale will be collected at the following ages for every child: - 3 months - 6 months - 12 months - 18 months - 24 months2
Wechsler Preschool and Primary Scale of Intelligence
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.
Time frame
All scores on this scale will be collected at the following ages for every child: - 3 years old - 5 years oldLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: