Clinical trial NCT03445689: Oxygenation Instability and Maturation of Control of Breathing in Premature Infants
Official title: Oxygenation Instability and Maturation of Control of Breathing in Premature Infants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infant,Premature
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2018-02-26
Enrollment: 70
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Preterm infants admitted to the neonatal intensive care unit will be screened and will be considered eligible for inclusion if they fulfill all of the following inclusion and none of the exclusion criteria.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Peripheral chemoreceptor control of breathing function
timeFrame: at 32 weeks corrected postmenstrual age
measure: Peripheral chemoreceptor control of breathing function
timeFrame: at 36 weeks corrected postmenstrual age
measure: Central chemoreceptor control of breathing function
timeFrame: at 32 weeks corrected postmenstrual age
measure: Central chemoreceptor control of breathing function
timeFrame: at 36 weeks corrected postmenstrual age
measure: Change in peripheral chemoreceptor control of breathing function
timeFrame: Change from 32 to 36 weeks postmenstrual age
measure: Change in central chemoreceptor control of breathing function
timeFrame: Change from 32 to 36 weeks postmenstrual age
Secondary outcomes:
measure: Ventilatory stability - Apnea frequency
timeFrame: at 32 and 36 weeks corrected postmenstrual age
measure: Ventilatory stability - Periodic breathing density
timeFrame: at 32 and 36 weeks corrected postmenstrual age
measure: Ventilatory stability - Time series analysis of inter-breath interval
timeFrame: at 32 and 36 weeks corrected postmenstrual age
measure: Mechanisms of episodic hypoxemia
timeFrame: at 32 and 36 weeks corrected postmenstrual age
measure: Apneic CO2 threshold in central apnea
timeFrame: at 32 and 36 weeks corrected postmenstrual age
measure: Apneic CO2 threshold during mechanical ventilation
timeFrame: at 32 and 36 weeks corrected postmenstrual age
Other outcomes:
Locations:
city: Miami
country: United States
facility: NICU at Holtz Children's Hospital
state: Florida
Study officials:
affiliation: University of Miami
name: Nelson Claure
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Miami
name: Eduardo Bancalari
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Miami
name: Deepak Jain
role: PRINCIPAL_INVESTIGATOR
References: