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Completed

NCT Number: NCT03163108

Closed-loop Automatic Oxygen Control (CLAC-4) in Preterm Infants

Two-center, randomised controlled, cross-over clinical trial in preterm infants born at gestational age below 34+1/7 weeks receiving supplemental oxygen and respiratory support (Continous positive airway pressure (CPAP) or Non-invasive Ventilation (NIV) or Invasive Ventilation (IV)). Routine manual control (RMC) of the fraction of inspired oxygen (FiO2) will be tested against RMC supported by closed-loop automatic control (CLAC) with "slow"-algorithm and RMC supported by CLAC with "fast"-algorithm.

The primary hypothesis is, that the use of the "faster" algorithm results in more time within arterial oxygen saturation (SpO2) target range compared to RMC only. The a-priori subordinate hypothesis is, that the faster algorithm is equally effective as the slower algorithm to maintain the SpO2 in the target range.

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Key information

Conditions

Infant Respiratory Distress Syndrome Bronchopulmonary Dysplasia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hyperoxia Hypoxia Infant, Newborn, Diseases Infant, Premature, Diseases Lung Diseases Lung Injury Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Atelectasis Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Ventilator Lung; Newborn Ventilator-Induced Lung Injury

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johannes Gutenberg University Mainz, Mainz, Germany

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About this study

BACKGROUND AND OBJECTIVE In preterm infants receiving supplemental oxygen, routine manual control (RMC) of the fraction of inspired oxygen (FiO2) is often difficult and time consuming. The investigators developed a system for closed-loop automatic control (CLAC) of the FiO2 and demonstrated its safety and efficacy in a multi-center study. The objective of this study is to test a revised, "faster" algorithm with a shorter WAIT-interval of 30sec (= time between FiO2 changes) against the previously tested algorithm (WAIT of 180sec) and against RMC. The primary hypothesis is, that the application of CLAC with the "faster" algorithm in addition to RMC results in more time within arterial oxygen saturation (SpO2) target range compared to RMC only. The a-priori subordinate hypothesis is, that the faster algorithm is equally effective as the slower algorithm to maintain the SpO2 in the target range.

Further hypotheses for exploratory testing are, that the "fast" algorithm will achieve a higher proportion of time with SpO2 within target range and an improved stability of cerebral oxygenation (measured as rcStO2 and rcFtO2E determined by Near-infrared spectroscopy) compared with the slow algorithm.

STUDY DESIGN The Study is designed as a two-center, randomized controlled, cross-over clinical trial in preterm infants receiving mechanical ventilation or nasal continuous positive airway pressure or non-invasive ventilation and supplemental oxygen (FiO2 above 0.21). Within a twenty-four-hour period the investigators will compare 8 hours of RMC with 8-hour periods of RMC supported by CLAC "slow" algorithm or "fast" algorithm, respectively.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • gestational age at birth <34+1/7weeks
  • invasive mechanical ventilation OR noninvasive ventilation OR continous positive airway pressure support
  • Fraction of inspired oxygen above 0.21 before inclusion
  • more than 2 hypoxaemic events (arterial oxygen saturation below 80%) within 8 hours before inclusion
  • parental written informed consent

Exclusion criteria

  • congenital pulmonary anomalies
  • diaphragmatic hernia or other diaphragmatic disorders

Treatment and study plan

Closed-loop automatic oxygen control (CLAC) fast in addition to RMC

Device

Closed-loop automatic oxygen control is an automated, algorithm based adjustment of the fraction of inspired oxygen in relation to arterial saturation (WAIT-interval 30s).

Closed-loop automatic oxygen control (CLAC) slow in addition to RMC

Device

Closed-loop automatic oxygen control is an automated, algorithm based adjustment of the fraction of inspired oxygen in relation to arterial saturation (WAIT-interval 180s).

Primary outcomes

  1. Proportion of time with SpO2 within target range

    Time frame: 16 hours

    Comparison of proportion of time with SpO2 within target range if the infant requires supplemental oxygen and time above target range if the infant requires no supplemental oxygen between CLAC-fast and RMC (superiority hypothesis).

  2. Proportion of Time with SpO2 within target range

    Time frame: 16 hours

    Comparison of proportion of time with SpO2 within target range if the infant requires supplemental oxygen and time above target range if the infant requires no supplemental oxygen between CLAC-fast and CLAC-slow (subordinate, non inferiority hypothesis).

Secondary outcomes

  1. Duration of hyperoxaemia

    Time frame: 16 hours

    Time with arterial oxygen saturation above 95% if the infant requires supplemental oxygen (hyperoxaemia).

  2. Duration of hypoxaemia

    Time frame: 16 hours

    Time with arterial oxygen saturation below 80% (hypoxaemia)

  3. Duration of "overshoot" hyperoxaemia

    Time frame: 16 hours

    Comparison of proportion of time with SpO2 higher than 95% after an automated increase of FiO2 between CLAC-fast and CLAC-slow.

  4. Number of "overshoot" hyperoxaemia

    Time frame: 16 hours

    Comparison of number of events with SpO2 higher than 95% after an automated increase of FiO2 between CLAC-fast and CLAC-slow.

  5. Stability of cerebral oxygenation

    Time frame: 24 hours

    "Area under the curve" of cerebral tissue saturation or fraction of tissue oxygen extraction outside of the infants Median +- 5% or outside of the "save" interval of 55-80% rcStO2.

Other outcomes

  1. Staff workload

    Time frame: 24 hours

    number of manual adjustments of inspired oxygen per time

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Collaborators

  • Heinen und Löwenstein GmbH & Co. KG
  • Johannes Gutenberg University Mainz

Registry information

Official study title

Closed-loop Automatic Oxygen Control (CLAC-4) in Preterm Infants: a Randomized Controlled Trial of a Revised Algorithm

Acronym: CLAC-4

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
May 22, 2017
Registry last updated
May 15, 2018

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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