Oxygenation Instability and Maturation of Control of Breathing in Premature Infants

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).

Conditions

• Infant,Premature

Interventions

OTHER

Assessment of oxygenation instability

Recordings of SpO2 and heart rate will be analyzed by dedicated software to obtain frequency, duration and severity of episodes of hypoxemia and hyperoxemia.

OTHER

Determination of mechanisms of hypoxemia episodes

Recordings of SpO2, heart rate, esophageal pressure, tidal volume, minute volume, respiratory rate and transcutaneous PCO2 will be analyzed to determine the prevalence, severity and duration of hypoxemia episodes produced by the different mechanisms.

OTHER

Assessment of respiratory instability

Recordings of tidal volume, minute volume and respiratory rate will be analyzed to determine frequency of apnea, periodic breathing, distribution of inter-breath intervals.

OTHER

apneic threshold of CO2

In mechanically ventilated infants the apneic threshold of CO2 will be measured by transcutaneous PCO2 following a step wise increase in ventilator rate until spontaneous breathing ceases transiently. In spontaneously breathing infants the apnea threshold of CO2 will be measured during episodes central apnea.

OTHER

Assessment of peripheral chemoreceptor function

The Dejours test will be used to assess peripheral chemoreceptor function by measuring the immediate ventilatory response to high-inspired oxygen.

OTHER

Assessment of central chemo-receptor function

Central chemo-receptor function will be assessed by measuring the ventilatory response to inspired CO2.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• University of Miami

  lead OTHER

Principal Investigators

• Nelson Claure · University of Miami

• Eduardo Bancalari · University of Miami

• Deepak Jain · University of Miami

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-09-04

Primary Completion

2023-11-01

Completion

2023-11-01

Countries

• United States

Study Locations