Oxygenation Instability and Maturation of Control of Breathing in Premature Infants
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Miami
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Central chemoreceptor control of breathing function
Study Overview
Brief Summary
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).
Detailed Description
Most extreme premature infants present with respiratory failure due to altered lung function compounded by breathing instability due to an immature respiratory control function.
Premature infants present with significant oxygenation instability in the form of frequent spontaneous episodes of hypoxemia during the first weeks after birth. As a result, these infants receive oxygen supplementation but this is often excessive and these infants are also exposed to hyperoxemia. The extent to which these episodes of hypoxemia or the exposure to hyperoxemia impact on the maturation and function of the control of breathing system in extreme premature infants during the evolving stages of their respiratory disease is unknown. This is a prospective study that will systematically evaluate such association in extreme premature infants.
The main 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).
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Central chemoreceptor control of breathing function
Time Frame: at 36 weeks corrected postmenstrual age
Ventilatory response to carbon dioxide
Peripheral chemoreceptor control of breathing function
Time Frame: at 36 weeks corrected postmenstrual age
Ventilatory response to oxygen (Dejours test)
Change in peripheral chemoreceptor control of breathing function
Time Frame: Change from 32 to 36 weeks postmenstrual age
Ventilatory response to oxygen (Dejours test)
Change in central chemoreceptor control of breathing function
Time Frame: Change from 32 to 36 weeks postmenstrual age
Ventilatory response to carbon dioxide
Secondary Outcomes
- Ventilatory stability - Periodic breathing density(at 32 and 36 weeks corrected postmenstrual age)
- Ventilatory stability - Apnea frequency(at 32 and 36 weeks corrected postmenstrual age)
- Ventilatory stability - Time series analysis of inter-breath interval(at 32 and 36 weeks corrected postmenstrual age)
- Apneic CO2 threshold during mechanical ventilation(at 32 and 36 weeks corrected postmenstrual age)
- Mechanisms of episodic hypoxemia(at 32 and 36 weeks corrected postmenstrual age)
- Apneic CO2 threshold in central apnea(at 32 and 36 weeks corrected postmenstrual age)
Investigators
Nelson Claure
Associate Professor
University of Miami