Intrauterine Growth Restriction Clinical Trial
Official title:
Effect of Intrauterine Growth Restriction on Respiratory Muscle Function and Exercise Tolerance in Childhood
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.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | January 30, 2022 |
Est. primary completion date | December 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 7 Years to 10 Years |
Eligibility | Inclusion Criteria: - (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) Exclusion Criteria: - Disability - Congenital heart disease - Current (active) respiratory infection |
Country | Name | City | State |
---|---|---|---|
Greece | University Hospital of Patras | Patras |
Lead Sponsor | Collaborator |
---|---|
University of Patras | European Society for Paediatric Research (ESPR) |
Greece,
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. — View Citation
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. Review. — View Citation
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. — View Citation
Godfrey S. Exercise Testing in Children. London, UK: WB Saunders Company Ltd., 1974.
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. — View Citation
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. — View Citation
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. Epub 2003 Mar 19. — View Citation
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. — View Citation
Regamey N, Moeller A. Paediatric exercise testing. Eur Respir Mon 2010; 47: 291-309
Rosenberg A. The IUGR newborn. Semin Perinatol. 2008 Jun;32(3):219-24. doi: 10.1053/j.semperi.2007.11.003. — View Citation
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. Review. — View Citation
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. — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | VO2 max | Maximum O2 consumption, in ml/kg/min. The index will be compared between IUGR and controls. | 1 day (during exercise testing) | |
Primary | 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) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04506970 -
Predicting Placental Pathologies by Ultrasound Imaging
|
||
Recruiting |
NCT03866863 -
Intra Uterine Growth Restriction
|
||
Recruiting |
NCT03662178 -
Investigating the Structured Use of Ultrasound Scanning for Fetal Growth
|
||
Not yet recruiting |
NCT05720169 -
Fetal, Obstetrics and Reproduction Genomics
|
||
Completed |
NCT04633551 -
Vascular Inflammation and Anti-inflammatory Supplements After Adverse Pregnancy Outcomes
|
N/A | |
Recruiting |
NCT05500989 -
PlacEntal Acute Atherosis RefLecting Subclinical Atherosclerosis
|
||
Recruiting |
NCT04141189 -
Comparison of Follow-up Protocols in Terms of Fetal, Neonatal and Maternal Results in Intrauterine Growth Retardation
|
N/A | |
Completed |
NCT03726697 -
Effect of Tahneek on Hypoglycemia in Newborn Infants
|
N/A | |
Recruiting |
NCT03398629 -
Diagnosis and Management of Intrauterine Growth Restriction and Congenital Anomalies
|
||
Recruiting |
NCT02473991 -
Correlation Between Placental Thickness in the Second and Third Trimester and Fetal Weight
|
N/A | |
Completed |
NCT02696577 -
The Effect of Omega 3 on Pregnancy Complicated by Asymmetrical Intrauterine Growth Restriction
|
Phase 2 | |
Recruiting |
NCT04766866 -
sFlt1/PlGF and Planned Delivery to Prevent Preeclampsia at Term.
|
N/A | |
Terminated |
NCT04047966 -
Study of the Fetal and Maternal Microbiota in Preganant Women With Fetal Defect Growth
|
||
Not yet recruiting |
NCT03865628 -
Ultrasound Evaluation of Fetal Hemodynamics and Perinatal Complications
|
||
Completed |
NCT05328453 -
Sonographic 3D Measurement of Fetal Thymus May be Used to Predict the Small Baby in Pregnancy.
|
||
Completed |
NCT05800938 -
The Effect of Oral Isosorbide Mononitrate Therapy on Umbilical Artery Doppler Resistance Index in Pregnancies With Intrauterine Growth Restriction: Prospective Randomized Control Trial
|
Phase 4 | |
Not yet recruiting |
NCT06226051 -
Growing Little PEAPODS Study
|
||
Recruiting |
NCT02807324 -
Women Specific Cardiac Recovery After Preeclampsia
|
||
Recruiting |
NCT02515292 -
Evaluation of Infants With Intrauterine Growth Restriction
|
N/A | |
Active, not recruiting |
NCT01942525 -
Influence of Intrauterine Growth Restriction on Amplitude-integrated EEG in Preterm Infants
|
N/A |