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

University Hospital Tuebingen

Status: Completed

Conditions: Infant Respiratory Distress Syndrome; Ventilator Lung; Newborn

Treatments: Device: Closed-loop automatic oxygen control (CLAC) fast in addition to RMC; Device: Closed-loop automatic oxygen control (CLAC) slow in addition to RMC

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03163108

CLAC-4

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 19 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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19 participants in 3 patient groups

RMC only

No Intervention group

Description:

routine manual control (RMC) of the fraction of inspired oxygen (FIO2)

CLAC slow

Active Comparator group

Description:

routine manual control (RMC) + Closed-loop automatic oxygen control (CLAC) with 180sec WAIT-Interval ("slow" algorithm) of the fraction of inspired oxygen (FIO2)

Treatment:

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

CLAC fast

Experimental group

Description:

routine manual control (RMC) + Closed-loop automatic oxygen control (CLAC) with 30sec WAIT-Interval ("fast" algorithm) of the fraction of inspired oxygen (FIO2)

Treatment:

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