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Clinical Trials/NCT03464396
NCT03464396
Completed
Not Applicable

Physiologic Biomarkers Predicting Ventilatory Instability and Hypoxemia in Pre Mature Infants

Washington University School of Medicine1 site in 1 country177 target enrollmentMay 14, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Respiratory Control in Premature Infants
Sponsor
Washington University School of Medicine
Enrollment
177
Locations
1
Primary Endpoint
Respiratory phenotype based on physiologic testing
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

The purpose of this research study is to improve our understanding of unstable breathing and heart blood flow patterns seen in premature infants. The investigator will use novel non-invasive measures to understand the determinants of these unstable breathing and heart flow patterns to potentially identify new therapies for their prevention.

Detailed Description

The investigator will look at results of breathing tests, non-invasive sound wave (ultrasound) test of the heart and blood vessel (Echocardiography), and a sample of blood to see if it is possible for early detection of breathing control and lung blood vessel dysfunction (pulmonary vascular disease) in infants that are at risk for exposure to long term low oxygen levels. A subset of infants will have a magnetic resonance Imaging study (MRI) between 37- 40 weeks gestational age (GA) or at the time of discharge, whichever comes first. Respiratory tests include: * Bedside Physiology Study completed at 28, 32, 36, 40, and 52 weeks GA in conjunction with the respiratory tests. A 90-minute recording will be made using standard recording equipment that includes a conventional pulse oximeter, an EEG, an airflow sampling catheter near the nose, and respiratory inductance plethysmography (RIP) bands. Standard bedside monitoring will continue during the physiologic studies * Carotid Body Function Test completed at 32, 36, 40 and 52 weeks GA. This test is to unmask respiratory instability in response to hyperoxia. * Challenge Test completed at 36 weeks GA. 1. Infants receiving nasal cannula flow with or without supplemental oxygen will undergo a Room Air Challenge Test. 2. Infants on RA alone will undergo a Hypoxia Challenge test. * Effects of Nasal Cannula Flow completed at 28, 32, 36, 40 and 52 week's GA. The flow will be increased through a nasal cannula. This test is to see how flow effects the breathing pattern. A subset of infants will have an MRI between 37-40 weeks GA or before discharge, whichever comes first. The MRI will allow the doctors to look and see if there is any injury present in the brain that can be linked to an abnormal breathing pattern called periodic breathing. A subset of infants will have an Echocardiogram (Echo) at 32, 36 and 52 weeks GA. The Echo is performed to assess cardiac structure and function. Echocardiography is performed routinely in premature newborns in the Neonatal Intensive Care Unit (NICU). The echocardiogram will be performed at the infant bedside and will be coordinated with bedside nurse. The infant will remain on a cardio-respiratory monitor during the echocardiogram for approximately 15 minutes. Infants that have an Echo will have a blood sample collected near the time of the Echo, 3-blood samples total. The purpose of collecting the blood sample is to detect if the Fibroblast Growth Factor (FGF2) level is elevated and possibly be a biomarker of early pulmonary hypertension in pre term infants validated with the echo.

Registry
clinicaltrials.gov
Start Date
May 14, 2018
End Date
March 9, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • All infants born between 24 0/7 and 28 6/7 weeks GA admitted to the Neonatal Intensive Care Unit at St. Louis Children's Hospital will be considered for enrollment.

Exclusion Criteria

  • Infants not likely to survive
  • Infant with significant heart disease
  • Infant with a significant congenital abnormalities of the central nervous system, nose, mouth lungs or ribs, or congenital diseases that affect lung growth
  • Physician refusal
  • Unlikely that the infant will be available for 52-week follow-up visit.

Outcomes

Primary Outcomes

Respiratory phenotype based on physiologic testing

Time Frame: 36 weeks post menstrual age

Categorization of subjects based on physiologic Challenge Tests into one of four respiratory phenotypes.

Study Sites (1)

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