Prematurity-Related Ventilatory Control
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | Any |
| Updated: | 5/18/2018 |
| Start Date: | May 14, 2018 |
| End Date: | June 30, 2021 |
| Contact: | Julie A Hoffmann, RN |
| Email: | hoffmann_j@wustl.edu |
| Phone: | 314-273-1990 |
Physiologic Biomarkers Predicting Ventilatory Instability and Hypoxemia in Pre Mature Infants
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.
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.
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 gestational age (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.
(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 gestational age (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.
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.
We found this trial at
1
site
Saint Louis, Missouri 63110
Principal Investigator: James Kemp, MD
Phone: 314-273-1990
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