Infant,Premature Clinical Trial
Official title:
Oxygenation Instability and Maturation of Control of Breathing in Premature Infants
Verified date | November 2023 |
Source | University of Miami |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Premature infants present with significant oxygenation instability in the form of frequent spontaneous episodes of hypoxemia during the first weeks after birth. These infants are also exposed to hyperoxemia. The objective of this study is to determine the extent to which exposure to frequent episodes of hypoxemia and hyperoxemia in extreme premature infants during the early stages of their evolving lung disease is associated with altered maturation and function of their respiratory control system. This study is part of the Prematurity-Related Ventilatory Control (Pre-Vent): Role in Respiratory Outcomes Clinical Research Centers (CRC) (U01) cooperative program of the National Heart Lung and Blood Institute (NHLBI) of the National Institutes of Health (NIH).
Status | Completed |
Enrollment | 70 |
Est. completion date | November 1, 2023 |
Est. primary completion date | November 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Premature infants born at 23 0/7- 28 6/7 weeks gestational age - Postnatal age up to equivalent to 36 weeks postmenstrual age - Requiring supplemental oxygen and/or receiving mechanical ventilation, CPAP, nasal ventilation or nasal cannula Exclusion Criteria: - Severe congenital anomalies that may affect life expectancy or pulmonary or neurosensory development - Severe CNS pathology that may alter respiratory control function |
Country | Name | City | State |
---|---|---|---|
United States | NICU at Holtz Children's Hospital | Miami | Florida |
Lead Sponsor | Collaborator |
---|---|
University of Miami | National Heart, Lung, and Blood Institute (NHLBI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Peripheral chemoreceptor control of breathing function | Ventilatory response to oxygen (Dejours test) | at 32 weeks corrected postmenstrual age | |
Primary | Peripheral chemoreceptor control of breathing function | Ventilatory response to oxygen (Dejours test) | at 36 weeks corrected postmenstrual age | |
Primary | Central chemoreceptor control of breathing function | Ventilatory response to carbon dioxide | at 32 weeks corrected postmenstrual age | |
Primary | Central chemoreceptor control of breathing function | Ventilatory response to carbon dioxide | at 36 weeks corrected postmenstrual age | |
Primary | Change in peripheral chemoreceptor control of breathing function | Ventilatory response to oxygen (Dejours test) | Change from 32 to 36 weeks postmenstrual age | |
Primary | Change in central chemoreceptor control of breathing function | Ventilatory response to carbon dioxide | Change from 32 to 36 weeks postmenstrual age | |
Secondary | Ventilatory stability - Apnea frequency | Frequency of apnea episodes per hour | at 32 and 36 weeks corrected postmenstrual age | |
Secondary | Ventilatory stability - Periodic breathing density | Percent of time with periodic breathing | at 32 and 36 weeks corrected postmenstrual age | |
Secondary | Ventilatory stability - Time series analysis of inter-breath interval | Tail slope of the log-scaled probability density function of the inter-breath time series | at 32 and 36 weeks corrected postmenstrual age | |
Secondary | Mechanisms of episodic hypoxemia | Classify etiology of episodes of hypoxemia as central, obstructive, or mixed apnea or active exhalation based on measurements of respiratory inductance plethysmography, esophageal pressure | at 32 and 36 weeks corrected postmenstrual age | |
Secondary | Apneic CO2 threshold in central apnea | Carbon dioxide level change at onset of central apnea | at 32 and 36 weeks corrected postmenstrual age | |
Secondary | Apneic CO2 threshold during mechanical ventilation | Carbon dioxide level change at onset of central apnea with stepwise increase in ventilator rate | at 32 and 36 weeks corrected postmenstrual age |
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