Development of Preterm Infants Born During the COVID-19 Pandemic (NCT07569523) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Development of Preterm Infants Born During the COVID-19 Pandemic
120 participantsStarted 2026-05
Plain-language 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.
Who can participate
Age range
5 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Bayley Scales Of Infant and Toddler Development
Timeframe: 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
2
Wechsler Preschool and Primary Scale of Intelligence
Timeframe: All scores on this scale will be collected at the following ages for every child: - 3 years old - 5 years old
Trial details
NCT IDNCT07569523
SponsorFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau