Development of Preterm Infants Born During the COVID-19 Pandemic

May 6, 2026 updated by: Joana Fernández Miró, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Estudio Del Desarrollo de Los niños Prematuros Nacidos Durante la Pandemia Por el COVID-19

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

120

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study 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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Preterm babies born during the COVID-19 pandemic (2020-21)
Diagnostic test: Evaluation of cognitive and psychomotor development through the Bayley Scales Of Infant and Toddler Development and Wechsler Preschool and Primary Scale of Intelligence
Comparative and longitudinal study of development
Preterm babies born after the COVID-19 pandemic (2023-24)
Diagnostic test: Evaluation of cognitive and psychomotor development through the Bayley Scales Of Infant and Toddler Development and Wechsler Preschool and Primary Scale of Intelligence
Comparative and longitudinal study of development

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bayley Scales Of Infant and Toddler Development
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 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.
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
Wechsler Preschool and Primary Scale of Intelligence
Time Frame: 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.
All scores on this scale will be collected at the following ages for every child: - 3 years old - 5 years old

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

December 1, 2029

Study Registration Dates

First Submitted

May 5, 2026

First Submitted That Met QC Criteria

May 5, 2026

First Posted (Actual)

May 6, 2026

Study Record Updates

Last Update Posted (Actual)

May 11, 2026

Last Update Submitted That Met QC Criteria

May 6, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIBSP-NPN-2025-20

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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