Oxygenation Instability and Maturation of Control of Breathing in Premature Infants

NCT03445689 | Completed DMC

• 2 other identifiers: 20161114U01HL133689
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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).

Conditions

Infant,Premature

Outcome Measures

Primary Outcomes (6)

• Peripheral chemoreceptor control of breathing function

  Ventilatory response to oxygen (Dejours test)

  at 32 weeks corrected postmenstrual age

• Peripheral chemoreceptor control of breathing function

  Ventilatory response to oxygen (Dejours test)

  at 36 weeks corrected postmenstrual age

• Central chemoreceptor control of breathing function

  Ventilatory response to carbon dioxide

  at 32 weeks corrected postmenstrual age

• Central chemoreceptor control of breathing function

  Ventilatory response to carbon dioxide

  at 36 weeks corrected postmenstrual age

• Change in peripheral chemoreceptor control of breathing function

  Ventilatory response to oxygen (Dejours test)

  Change from 32 to 36 weeks postmenstrual age

• Change in central chemoreceptor control of breathing function

  Ventilatory response to carbon dioxide

  Change from 32 to 36 weeks postmenstrual age

Secondary Outcomes (6)

• Ventilatory stability - Apnea frequency

  at 32 and 36 weeks corrected postmenstrual age

• Ventilatory stability - Periodic breathing density

  at 32 and 36 weeks corrected postmenstrual age

• Ventilatory stability - Time series analysis of inter-breath interval

  at 32 and 36 weeks corrected postmenstrual age

• Mechanisms of episodic hypoxemia

  at 32 and 36 weeks corrected postmenstrual age

• Apneic CO2 threshold in central apnea

  at 32 and 36 weeks corrected postmenstrual age

Interventions

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.

Also known as: Dejours test

Assessment of central chemo-receptor function OTHER

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

Also known as: Ventilatory response to CO2

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Severe congenital anomalies that may affect life expectancy or pulmonary or neurosensory development
• Severe CNS pathology that may alter respiratory control function

Sponsors & Collaborators

• University of Miami: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

NICU at Holtz Children's Hospital

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Nelson Claure

  University of Miami

  PRINCIPAL INVESTIGATOR

• Eduardo Bancalari

  University of Miami

  PRINCIPAL INVESTIGATOR

• Deepak Jain

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 6, 2018
• First Posted: February 26, 2018
• Study Start: September 4, 2018
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: March 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)