Development of Preterm Infants Born During the COVID-19 Pandemic

NCT07569523 | Not Yet Recruiting DMC

• 1 other identifier: IIBSP-NPN-2025-20
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Preterm Infant Development; COVID - 19

Outcome Measures

Primary Outcomes (2)

• Bayley Scales Of Infant and Toddler Development

  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

  All scores on this scale will be collected at the following ages for every child: - 3 years old - 5 years old

Study Arms (2)

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

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

Interventions

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

Comparative and longitudinal study of development

Preterm babies born after the COVID-19 pandemic (2023-24); Preterm babies born during the COVID-19 pandemic (2020-21)

Eligibility Criteria

• Age: Up to 5 Years
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Concurrent diagnosis of genetic pathology or major malformations.
• Families who discontinued follow-up or did not attend scheduled appointments.

Sponsors & Collaborators

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

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical psychologist

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: May 6, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: May 6, 2026

Record last verified: 2026-04