NCT05211297

Impact of Suspected Preterm Labour on Cardiometabolic Profile and Neurodevelopment

Impact of Suspected Preterm Labour During Pregnancy on Cardiometabolic Profile and Neurodevelopment During Childhood: a Prospective Cohort Study Protocol.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 112 (actual)
• Sponsor: Instituto de Investigación Sanitaria Aragón · Academic / Other
• Sex: All
• Age: 6 Years – 8 Years
• Healthy volunteers: Accepted

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.

Conditions

• Preterm Labor

Timeline

• Start date: 2021-03-01
• Primary completion: 2022-10-01
• Completion: 2022-12-01
• First posted: 2022-01-27
• Last updated: 2023-01-10

Locations

1 site across 1 country: Spain