Preterm Infant DevelopmentNCT07569523
Development of Preterm Infants Born During the COVID-19 Pandemic
An observational study of Preterm Infant Development and COVID - 19, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 5 years
- Conditions the study is for
- Preterm Infant Development, COVID - 19
- What is being tested?
- Evaluation of cognitive and psychomotor development through the Bayley Scales Of Infant and Toddler Development and Wechsler Preschool and Primary Scale of Intelligence
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- May 2026to Dec 2029
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 5 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: 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.
- Conditions
- Preterm Infant Development, COVID - 19
- Being tested
- Evaluation of cognitive and psychomotor development through the Bayley Scales Of Infant and Toddler Development and Wechsler Preschool and Primary Scale of Intelligence
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of cognitive and psychomotor development through the Bayley Scales Of Infant and Toddler Development and Wechsler Preschool and Primary Scale of IntelligenceDiagnostic test
Comparative and longitudinal study of development
| Study group | Role | What they receive |
|---|---|---|
| Preterm babies born during the COVID-19 pandemic (2020-21) | Not described Receives: 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) | Not described Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: All scores on this scale will be collected at the following ages for every child: - 3 years old - 5 years old
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study startMay 2026 (estimated)
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm Infant DevelopmentStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 120 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joana Fernández Miró, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07569523
- Sponsor's protocol ID
- IIBSP-NPN-2025-20
- Status last verified
- Apr 2026
- First submitted
- 5 May 2026
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estudio Del Desarrollo de Los niños Prematuros Nacidos Durante la Pandemia Por el COVID-19
- ClinicalTrials.gov ID
- NCT07569523
- Acronym / sponsor ID
- IIBSP-NPN-2025-20
- Conditions
- Preterm Infant Development, COVID - 19
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 6 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Other
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluation of cognitive and psychomotor development through the Bayley Scales Of Infant and Toddler Development and Wechsler Preschool and Primary Scale of IntelligenceComparative and longitudinal study of development | Diagnostic test | Preterm babies born after the COVID-19 pandemic (2023-24), Preterm babies born during the COVID-19 pandemic (2020-21) |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Infant Development and COVID - 19, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.