Impact of Suspected Preterm Labour on Cardiometabolic Profile and Neurodevelopment

NCT05211297 | Completed

• 1 other identifier: Superkids study
• Study Type: observational
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm Labor

Keywords

pregnancy; preterm labor; neurodevelopment; cardiovascular; metabolic; prematurity

Outcome Measures

Primary Outcomes (10)

• Percentage of fat mass and total and regional lean mass

  6-8 years

• Body mass index and adiposity

  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.

  6-8 years

• Systolic and diastolic blood pressure

  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).

  6-8 years

• General intelligence index

  6-8 years

• Visual development test

  6-8 years

• Global index of problems

  6-8 years

• Index of emotional problems

  6-8 years

• Index of behavioral problems

  6-8 years

Study Arms (2)

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.

Eligibility Criteria

• Age: 6 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

• Multiple pregnancy
• Malformations
• Chromosomal diseases
• Prenatal infections

Sponsors & Collaborators

• Instituto de Investigación Sanitaria Aragón: lead
• Instituto de Salud Carlos III: collaborator

Study Sites (1)

Cristina Paules

Zaragoza, Aragon, 50009, Spain

Location

MeSH Terms

Conditions

Obstetric Labor, Premature; Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Cristina Paules

  IISAragon . Clini Hospital Zaragoza.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 8, 2022
• First Posted: January 27, 2022
• Study Start: March 1, 2021
• Primary Completion: October 1, 2022
• Study Completion: December 1, 2022
• Last Updated: January 10, 2023

Record last verified: 2023-01

Locations

ES (1)