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NCT Number: NCT03445689

Oxygenation Instability and Maturation of Control of Breathing in Premature Infants

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).

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Key information

Conditions

Infant,Premature Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

NICU at Holtz Children's Hospital

Miami, Florida, 33136, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Assessment of oxygenation instability

Other

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

Determination of mechanisms of hypoxemia episodes

Other

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.

Assessment of respiratory instability

Other

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

apneic threshold of CO2

Other

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.

Assessment of peripheral chemoreceptor function

Other

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

Other names: Dejours test

Assessment of central chemo-receptor function

Other

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

Other names: Ventilatory response to CO2

Primary outcomes

  1. Peripheral chemoreceptor control of breathing function

    Time frame: at 32 weeks corrected postmenstrual age

    Ventilatory response to oxygen (Dejours test)

  2. Peripheral chemoreceptor control of breathing function

    Time frame: at 36 weeks corrected postmenstrual age

    Ventilatory response to oxygen (Dejours test)

  3. Central chemoreceptor control of breathing function

    Time frame: at 32 weeks corrected postmenstrual age

    Ventilatory response to carbon dioxide

  4. Central chemoreceptor control of breathing function

    Time frame: at 36 weeks corrected postmenstrual age

    Ventilatory response to carbon dioxide

  5. Change in peripheral chemoreceptor control of breathing function

    Time frame: Change from 32 to 36 weeks postmenstrual age

    Ventilatory response to oxygen (Dejours test)

  6. 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

  1. Ventilatory stability - Apnea frequency

    Time frame: at 32 and 36 weeks corrected postmenstrual age

    Frequency of apnea episodes per hour

  2. Ventilatory stability - Periodic breathing density

    Time frame: at 32 and 36 weeks corrected postmenstrual age

    Percent of time with periodic breathing

  3. Ventilatory stability - Time series analysis of inter-breath interval

    Time frame: at 32 and 36 weeks corrected postmenstrual age

    Tail slope of the log-scaled probability density function of the inter-breath time series

  4. Mechanisms of episodic hypoxemia

    Time frame: at 32 and 36 weeks corrected postmenstrual age

    Classify etiology of episodes of hypoxemia as central, obstructive, or mixed apnea or active exhalation based on measurements of respiratory inductance plethysmography, esophageal pressure

  5. Apneic CO2 threshold in central apnea

    Time frame: at 32 and 36 weeks corrected postmenstrual age

    Carbon dioxide level change at onset of central apnea

  6. Apneic CO2 threshold during mechanical ventilation

    Time frame: at 32 and 36 weeks corrected postmenstrual age

    Carbon dioxide level change at onset of central apnea with stepwise increase in ventilator rate

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

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

Registry information

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Feb 26, 2018
Registry last updated
Mar 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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