MedTrace Logo

IUGR, Respiratory Muscle Function, and Exercise Capacity in Childhood

NCT03368755 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2021-04-28

No results posted yet for this study

Summary

The study hypothesis is that intrauterine growth restriction (IUGR) may have long-term effects on respiratory muscle (RM) function, thus leading to reduced exercise capacity later in life. The objective is to investigate the above hypothesis by comparing RM function and cardiopulmonary exercise testing (CPET) parameters between school-aged children exposed to IUGR and healthy controls.

Conditions

  • Intrauterine Growth Restriction
  • Cardiopulmonary Disease

Interventions

DIAGNOSTIC_TEST

Cardiopulmonary Exercise Testing

Pimax, Pemax, airway pressure at 100 msec after occlusion (P0.1), and Ti and Ttot will be measured by the Micro 5000 device (Medisoft, Sorinnes, Belgium). TTImus will be calculated as (Pimean / Pimax) x (Ti / Ttot), where Pimean is the mean airway pressure resulting from the formula Pimean = 5 x P0.1 x Ti9. RM function will be determined a) prior to CPET, b) during CPET when the anaerobic threshold (AT) will be reached, and c) after CPET, when heart rate (HR) and oxygen consumption will be normalized.

DIAGNOSTIC_TEST

Respiratory Muscle Strength and Endurance

CPET will be performed by the Ultima CPX system (Medgraphics, St. Paul, USA), using a cycle ergometer and according to a standardized protocol. The following parameters will be recorded: total work in Watts, maximum HR, maximum oxygen consumption (VO2max), AT indices (work, HR, VO2 ) and duration of recovery.

Sponsors & Collaborators

  • European Society for Paediatric Research (ESPR)

    collaborator UNKNOWN

  • University of Patras

    lead OTHER

Principal Investigators

  • Sotirios Fouzas, MD, PhD · University of Patras, Greece

  • Gabriel Dimitriou, MD, PhD · University of Patras, Greece

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-08
Primary Completion
2021-12-31
Completion
2022-01-30

Countries

  • Greece

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03368755 on ClinicalTrials.gov