Clinical trial NCT05211297: Impact of Suspected Preterm Labour on Cardiometabolic Profile and Neurodevelopment
Official title: Impact of Suspected Preterm Labour During Pregnancy on Cardiometabolic Profile and Neurodevelopment During Childhood: a Prospective Cohort Study Protocol.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preterm Labor
Keywords: pregnancy
preterm labor
neurodevelopment
cardiovascular
metabolic
prematurity
Lead sponsor: Instituto de Investigación Sanitaria Aragón
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
First posted: 2022-01-27
Enrollment: 112
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* Singleton pregnancy
* Good understanding and sign of informed consent.

Exclusion Criteria:

* Multiple pregnancy
* Malformations
* Chromosomal diseases
* Prenatal infections

Primary outcomes:
measure: Percentage of fat mass and total and regional lean mass
timeFrame: 6-8 years
measure: Body mass index and adiposity
timeFrame: 6-8 years
measure: Cardio-respiratory resistance
timeFrame: 6-8 years
measure: Systolic and diastolic blood pressure
timeFrame: 6-8 years
measure: Left ventricle (LV) systolic and diastolic function
timeFrame: 6-8 years
measure: General intelligence index
timeFrame: 6-8 years
measure: Visual development test
timeFrame: 6-8 years
measure: Global index of problems
timeFrame: 6-8 years
measure: Index of emotional problems
timeFrame: 6-8 years
measure: Index of behavioral problems
timeFrame: 6-8 years
Secondary outcomes:
Other outcomes:
Locations:
city: Zaragoza
country: Spain
facility: Cristina Paules
state: Aragón
Study officials:
affiliation: IISAragon . Clini Hospital Zaragoza.
name: Cristina Paules
role: PRINCIPAL_INVESTIGATOR
References: