Preterm LaborSKsNCT05211297
Impact of Suspected Preterm Labour on Cardiometabolic Profile and Neurodevelopment
An observational study of Preterm Labor, run by Instituto de Investigación Sanitaria Aragón at 1 site in Spain.
Trial summary
Suspected preterm labour (SPL), define as the presence of regular and painful uterine contractions and cervical shortening, constitute a prenatal insult with potential long-term consequences. Read more about this study
- Who is it for?
- Ages 6 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Preterm Labor
- How many people
- 112 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2021to 1 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 6 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Two cohorts of children at 6-8 years of age: A. Exposed cohort: children whose mothers suffered a suspected preterm labour during pregnancy. They are subdivided into: * Moderate-late preterm births (between 32 and 37 weeks of gestation) * "False suspected preterm labour" (full-term births (> 37 weeks) after suffering a suspected preterm labour) B. Unexposed cohort: children born at term (> 37 weeks) whose mothers did not suffer a suspected preterm labour during pregnancy.
Who may be able to join
- Singleton pregnancy
- Good understanding and sign of informed consent.
Who cannot join
- Multiple pregnancy
- Malformations
- Chromosomal diseases
- Prenatal infections
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Suspected Preterm Labour During Pregnancy on Cardiometabolic Profile and Neurodevelopment During Childhood: a Prospective Cohort Study Protocol.
Suspected preterm labour (SPL), define as the presence of regular and painful uterine contractions and cervical shortening, constitute a prenatal insult with potential long-term consequences. However, despite recent evidence demonstrating a suboptimal neurodevelopment at 2 years in this population, it remains under-recognized as a significant risk factor for neurodevelopmental disorders or other chronic diseases. The objective of this study is to assess the impact of suspected preterm labour during pregnancy on cardiometabolic profile and neurodevelopment during childhood (6-8 years).
Prospective cohort study including children whose mothers suffered a suspected preterm labor during pregnancy and paired controls. A neurodevelopment, cardiovascular and metabolic assessment at 6-8 years of age will be performed. A trained psychologist will carry out the neurodevelopment assessment. Body composition and physical fitness assessment will be performed by one trained pediatrician and nurse. Finally, cardiovascular assessment, including echocardiography and blood pressure, will be performed by two pediatric cardiologists. Data regarding perinatal and postnatal characteristics, diet, lifestyle and weekly screen time of the child will be obtained from clinical histories and direct interviews with the families. Primary outcome measures will include body mass index and adiposity, percentage of fat mass and total and regional lean mass, bone mineral content and density, cardio-respiratory resistance, isometric muscle strength, dynamic lower body strength, systolic and diastolic blood pressure, left ventricle (LV) systolic and diastolic function, general intelligence index, visuospatial working memory span, visual development test, visual acuity, index of emotional and behavioral problems.
- Conditions
- Preterm Labor
- Keywords
- pregnancy, preterm labor, neurodevelopment, cardiovascular, metabolic, prematurity
- Medical subject headings
- Obstetric Labor, Premature, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Exposed cohort: | Children whose mothers suffered a suspected preterm labour during pregnancy. | |
| Unexposed cohort | Children born at term (> 37 weeks) whose mothers did not suffer a suspected preterm labour during pregnancy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of fat mass and total and regional lean mass
Measured: 6-8 years
Body mass index and adiposity
Measured: 6-8 years
Cardio-respiratory resistance
After fitting the safety harness, the test began when the participants were able to walk easily on the treadmill (Quasar Med 4.0, h/p/cosmos, Nußdorf, Germany). The protocol started with a speed of 2.4 km/h, increasing by 0.8 km/h every 2 min until the participants were unable to walk or reached a speed of 4.8 km/h. Then, the slope was increased by 4% every minute until exhaustion or up to a maximal slope of 24%. The respiratory gas exchange data were measured breath-by-breath using open-circuit spirometry (Oxycon Pro, Jaeger/Viasys Healthcare, Hoechberg, Germany). Maximal oxygen uptake (VO2max) values were averaged over consecutive 15 s periods.
Measured: 6-8 years
Systolic and diastolic blood pressure
Measured: 6-8 years
Left ventricle (LV) systolic and diastolic function
End-diastolic and end-systolic diameter, septum and posterior wall thickness, heart rate, ejection fraction (by Teicholz and biplane Simpson methods), mitral annulus S´ wave velocity (tissue doppler), mitral annulus E and A waves velocity (pulse-wave doppler), E´ and A´ waves velocity (tissue doppler), TEI index (tissue doppler) and LV strain and strain rate at three apical views (speckle tracking).
Measured: 6-8 years
General intelligence index
Measured: 6-8 years
Visual development test
Measured: 6-8 years
Global index of problems
Measured: 6-8 years
Index of emotional problems
Measured: 6-8 years
Index of behavioral problems
Measured: 6-8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start1 Mar 2021
- Primary completion1 Oct 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm LaborStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Sanitaria Aragón
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Responsible party
- Principal investigator, Cristina Paules, Instituto de Investigación Sanitaria Aragón
- Investigators
- Cristina Paules, Principal investigator, IISAragon . Clini Hospital Zaragoza.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05211297
- Sponsor's protocol ID
- Superkids study
- Acronym
- SKs
- Status last verified
- Jan 2023
- First submitted
- 8 Jan 2022
- Last updated
- 10 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Suspected Preterm Labour During Pregnancy on Cardiometabolic Profile and Neurodevelopment During Childhood: a Prospective Cohort Study Protocol.
- ClinicalTrials.gov ID
- NCT05211297
- Acronym / sponsor ID
- SKs / Superkids study
- Conditions
- Preterm Labor
- Keywords
- pregnancy, preterm labor, neurodevelopment, cardiovascular, metabolic, prematurity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Instituto de Investigación Sanitaria AragónUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 27 Jan 2022 (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.
Suspected preterm labour (SPL), define as the presence of regular and painful uterine contractions and cervical shortening, constitute a prenatal insult with potential long-term consequences. However, despite recent evidence demonstrating a suboptimal neurodevelopment at 2 years in this population, it remains under-recognized as a significant risk factor for neurodevelopmental disorders or other chronic diseases. The objective of this study is to assess the impact of suspected preterm labour during pregnancy on cardiometabolic profile and neurodevelopment during childhood (6-8 years).
Prospective cohort study including children whose mothers suffered a suspected preterm labor during pregnancy and paired controls. A neurodevelopment, cardiovascular and metabolic assessment at 6-8 years of age will be performed. A trained psychologist will carry out the neurodevelopment assessment. Body composition and physical fitness assessment will be performed by one trained pediatrician and nurse. Finally, cardiovascular assessment, including echocardiography and blood pressure, will be performed by two pediatric cardiologists. Data regarding perinatal and postnatal characteristics, diet, lifestyle and weekly screen time of the child will be obtained from clinical histories and direct interviews with the families. Primary outcome measures will include body mass index and adiposity, percentage of fat mass and total and regional lean mass, bone mineral content and density, cardio-respiratory resistance, isometric muscle strength, dynamic lower body strength, systolic and diastolic blood pressure, left ventricle (LV) systolic and diastolic function, general intelligence index, visuospatial working memory span, visual development test, visual acuity, index of emotional and behavioral problems.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposed cohort: | – | –Children whose mothers suffered a suspected preterm labour during pregnancy. |
| Unexposed cohort | – | –Children born at term (> 37 weeks) whose mothers did not suffer a suspected preterm labour during pregnancy. |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Two cohorts of children at 6-8 years of age: A. Exposed cohort: children whose mothers suffered a suspected preterm labour during pregnancy. They are subdivided into: * Moderate-late preterm births (between 32 and 37 weeks of gestation) * "False suspected preterm labour" (full-term births (> 37 weeks) after suffering a suspected preterm labour) B. Unexposed cohort: children born at term (> 37 weeks) whose mothers did not suffer a suspected preterm labour during pregnancy.
Key inclusion criteria (2 listed)
- Singleton pregnancy
- Good understanding and sign of informed consent.
Key exclusion criteria (4 listed)
- Multiple pregnancy
- Malformations
- Chromosomal diseases
- Prenatal infections
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of fat mass and total and regional lean mass
Time frame: 6-8 years
Body mass index and adiposity
Time frame: 6-8 years
Cardio-respiratory resistance
Time frame: 6-8 years
After fitting the safety harness, the test began when the participants were able to walk easily on the treadmill (Quasar Med 4.0, h/p/cosmos, Nußdorf, Germany). The protocol started with a speed of 2.4 km/h, increasing by 0.8 km/h every 2 min until the participants were unable to walk or reached a speed of 4.8 km/h. Then, the slope was increased by 4% every minute until exhaustion or up to a maximal slope of 24%. The respiratory gas exchange data were measured breath-by-breath using open-circuit spirometry (Oxycon Pro, Jaeger/Viasys Healthcare, Hoechberg, Germany). Maximal oxygen uptake (VO2max) values were averaged over consecutive 15 s periods.
Systolic and diastolic blood pressure
Time frame: 6-8 years
Left ventricle (LV) systolic and diastolic function
Time frame: 6-8 years
End-diastolic and end-systolic diameter, septum and posterior wall thickness, heart rate, ejection fraction (by Teicholz and biplane Simpson methods), mitral annulus S´ wave velocity (tissue doppler), mitral annulus E and A waves velocity (pulse-wave doppler), E´ and A´ waves velocity (tissue doppler), TEI index (tissue doppler) and LV strain and strain rate at three apical views (speckle tracking).
General intelligence index
Time frame: 6-8 years
Visual development test
Time frame: 6-8 years
Global index of problems
Time frame: 6-8 years
Index of emotional problems
Time frame: 6-8 years
Index of behavioral problems
Time frame: 6-8 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2023.
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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. This study is not recruiting at the moment.
Cristina Paules principal investigator
IISAragon . Clini Hospital Zaragoza.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Labor, run by Instituto de Investigación Sanitaria Aragón at 1 site in Spain.
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 2 inclusion and 4 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: finished, as of the sponsor's last update on 10 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage of fat mass and total and regional lean mass (time frame: 6-8 years). The study lists 10 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 10 Jan 2023.