Oxygenation Instability and Maturation of Control of Breathing in Premature Infants

University of Miami

Status: Completed

Conditions: Infant,Premature

Treatments: Other: Assessment of respiratory instability; Other: Assessment of oxygenation instability; Other: Determination of mechanisms of hypoxemia episodes; Other: Assessment of central chemo-receptor function; Other: apneic threshold of CO2; Other: Assessment of peripheral chemoreceptor function

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT03445689

U01HL133689 (U.S. NIH Grant/Contract)

20161114

Details and patient eligibility

About

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).

Full 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).

Enrollment: 70 patients

Sex: All

Volunteers: No Healthy Volunteers

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