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Oxygenation Instability and Maturation of Control of Breathing in Premature Infants

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ClinicalTrials.gov Identifier: NCT03445689
Recruitment Status : Recruiting
First Posted : February 26, 2018
Last Update Posted : October 22, 2020
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Nelson Claure, University of Miami

Study Description
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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).


Condition or disease Intervention/treatment
Infant,Premature Other: Assessment of oxygenation instability Other: Determination of mechanisms of hypoxemia episodes Other: Assessment of respiratory instability Other: apneic threshold of CO2 Other: Assessment of peripheral chemoreceptor function Other: Assessment of central chemo-receptor function

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).

Study Design
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Study Type : Observational
Estimated Enrollment : 105 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Oxygenation Instability and Maturation of Control of Breathing in Premature Infants
Actual Study Start Date : September 4, 2018
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2021
Groups and Cohorts
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Intervention Details:
  • 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 Name: Dejours test
  • Other: Assessment of central chemo-receptor function
    Central chemo-receptor function will be assessed by measuring the ventilatory response to inspired CO2.
    Other Name: Ventilatory response to CO2

Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • Premature infants born at 23 0/7- 28 6/7 weeks gestational age
  • Postnatal age up to 28 days
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03445689


Contacts
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Contact: Carmen D'Ugard 3055856404 cdugard@med.miami.edu
Contact: Ana C Aguilar 3055856404 aca135@med.miami.edu

Locations
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United States, Florida
NICU at Holtz Children's Hospital Recruiting
Miami, Florida, United States, 33136
Contact: Carmen D'Ugard    305-585-6404    cdugard@med.miami.edu   
Contact: Ana C Aguilar    3055856404    aca135@med.miami.edu   
Sponsors and Collaborators
University of Miami
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Nelson Claure University of Miami
Principal Investigator: Eduardo Bancalari University of Miami
Principal Investigator: Deepak Jain University of Miami
More Information
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Responsible Party: Nelson Claure, Associate Professor, University of Miami
ClinicalTrials.gov Identifier: NCT03445689    
Other Study ID Numbers: 20161114
First Posted: February 26, 2018    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications