Oxygenation Instability and Maturation of Control of Breathing in Premature Infants

CompletedOBSERVATIONAL
Enrollment

70

Participants

Timeline

Start Date

September 4, 2018

Primary Completion Date

November 1, 2023

Study Completion Date

November 1, 2023

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.

Trial Locations (1)

33136

NICU at Holtz Children's Hospital, Miami

All Listed Sponsors
collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

lead

University of Miami

OTHER

NCT03445689 - Oxygenation Instability and Maturation of Control of Breathing in Premature Infants | Biotech Hunter | Biotech Hunter