IUGR, Respiratory Muscle Function, and Exercise Capacity in Childhood

NCT03368755 | Unknown DMC

• 1 other identifier: IUGR-CPET_PATRAS
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• VO2 max

  Maximum O2 consumption, in ml/kg/min. The index will be compared between IUGR and controls.

  1 day (during exercise testing)

• TTmus

  Tension-time index of the respiratory muscles. No values (ratio). The index will be compared between IUGR and controls.

  1 day (during exercise testing)

Study Arms (2)

Cases (IUGR)

EXPERIMENTAL

50 school-aged children (7-10 years old) exposed to IUGR (birth weight \<10th percentile \& fetal ultrasound documentation) and of comparable gestational age with controls Intervention: Cardiopulmonary Exercise Testing and Respiratory Muscle Strength and Endurance

Diagnostic Test: Cardiopulmonary Exercise Testing; Diagnostic Test: Respiratory Muscle Strength and Endurance

Controls

ACTIVE COMPARATOR

100 school-aged children (7-10 years old) not exposed to IUGR (birth weight \<10th percentile \& fetal ultrasound documentation) and of comparable gestational age with cases. Intervention: Cardiopulmonary Exercise Testing and Respiratory Muscle Strength and Endurance

Diagnostic Test: Cardiopulmonary Exercise Testing; Diagnostic Test: Respiratory Muscle Strength and Endurance

Interventions

Cardiopulmonary Exercise Testing DIAGNOSTIC_TEST

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.

Cases (IUGR); Controls

Respiratory Muscle Strength and Endurance DIAGNOSTIC_TEST

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.

Cases (IUGR); Controls

Eligibility Criteria

• Age: 7 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• (Cases) School-aged children (7-10 years old) exposed to IUGR (birth weight \<10th percentile \& fetal ultrasound documentation)
• (Controls) School-aged children (7-10 years old) NOT exposed to IUGR (birth weight \>10th percentile)

You may not qualify if:

• Disability
• Congenital heart disease
• Current (active) respiratory infection

Sponsors & Collaborators

• University of Patras: lead
• European Society for Paediatric Research (ESPR): collaborator

Study Sites (1)

University Hospital of Patras

Pátrai, 26442, Greece

RECRUITING

Related Publications (12)

• Svedenkrans J, Henckel E, Kowalski J, Norman M, Bohlin K. Long-term impact of preterm birth on exercise capacity in healthy young men: a national population-based cohort study. PLoS One. 2013 Dec 6;8(12):e80869. doi: 10.1371/journal.pone.0080869. eCollection 2013.

  PMID: 24324639 BACKGROUND

• Rosenberg A. The IUGR newborn. Semin Perinatol. 2008 Jun;32(3):219-24. doi: 10.1053/j.semperi.2007.11.003.

  PMID: 18482625 BACKGROUND

• Lane RH, Chandorkar AK, Flozak AS, Simmons RA. Intrauterine growth retardation alters mitochondrial gene expression and function in fetal and juvenile rat skeletal muscle. Pediatr Res. 1998 May;43(5):563-70. doi: 10.1203/00006450-199805000-00001.

  PMID: 9585000 BACKGROUND

• Lane RH, Maclennan NK, Daood MJ, Hsu JL, Janke SM, Pham TD, Puri AR, Watchko JF. IUGR alters postnatal rat skeletal muscle peroxisome proliferator-activated receptor-gamma coactivator-1 gene expression in a fiber specific manner. Pediatr Res. 2003 Jun;53(6):994-1000. doi: 10.1203/01.PDR.0000064583.40495.51. Epub 2003 Mar 19.

  PMID: 12646730 BACKGROUND

• Kilbride HW, Gelatt MC, Sabath RJ. Pulmonary function and exercise capacity for ELBW survivors in preadolescence: effect of neonatal chronic lung disease. J Pediatr. 2003 Oct;143(4):488-93. doi: 10.1067/S0022-3476(03)00413-X.

  PMID: 14571227 BACKGROUND

• Dempsey JA, Romer L, Rodman J, Miller J, Smith C. Consequences of exercise-induced respiratory muscle work. Respir Physiol Neurobiol. 2006 Apr 28;151(2-3):242-50. doi: 10.1016/j.resp.2005.12.015.

  PMID: 16616716 BACKGROUND

• Regamey N, Moeller A. Paediatric exercise testing. Eur Respir Mon 2010; 47: 291-309

  BACKGROUND

• McConnell AK. CrossTalk opposing view: respiratory muscle training does improve exercise tolerance. J Physiol. 2012 Aug 1;590(15):3397-8; discussion 3399-400. doi: 10.1113/jphysiol.2012.235572. No abstract available.

  PMID: 22855045 BACKGROUND

• American Thoracic Society/European Respiratory Society. ATS/ERS Statement on respiratory muscle testing. Am J Respir Crit Care Med. 2002 Aug 15;166(4):518-624. doi: 10.1164/rccm.166.4.518. No abstract available.

  PMID: 12186831 BACKGROUND

• Foglio K, Clini E, Facchetti D, Vitacca M, Marangoni S, Bonomelli M, Ambrosino N. Respiratory muscle function and exercise capacity in multiple sclerosis. Eur Respir J. 1994 Jan;7(1):23-8. doi: 10.1183/09031936.94.07010023.

  PMID: 8143827 BACKGROUND

• Godfrey S. Exercise Testing in Children. London, UK: WB Saunders Company Ltd., 1974.

  BACKGROUND

• Ross MG, Beall MH. Adult sequelae of intrauterine growth restriction. Semin Perinatol. 2008 Jun;32(3):213-8. doi: 10.1053/j.semperi.2007.11.005.

  PMID: 18482624 BACKGROUND

MeSH Terms

Conditions

Fetal Growth Retardation; Pulmonary Heart Disease

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Study Officials

• Sotirios Fouzas, MD, PhD

  University of Patras, Greece

  PRINCIPAL INVESTIGATOR

• Gabriel Dimitriou, MD, PhD

  University of Patras, Greece

  STUDY CHAIR

Central Study Contacts

Sotirios Fouzas, MD, PhD

CONTACT

+302610999980; sfouzas@upatras.gr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Pulmonologist, Assistant Professor in Pediatrics

Study Record Dates

• First Submitted: November 24, 2017
• First Posted: December 11, 2017
• Study Start: January 8, 2018
• Primary Completion: December 31, 2021
• Study Completion: January 30, 2022
• Last Updated: April 28, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)