Please select the eligibility criteria that correspond to the clinical trial below.
Title: Closed-loop Automatic Oxygen Control (CLAC-4) in Preterm Infants: a Randomized Controlled Trial of a Revised Algorithm
Brief Summary: 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.


Options:
A: Inclusion Criteria:

Preterm infants less than 33 weeks (23+0 to 32+6 weeks)

• Receiving invasive or non-invasive mode of respiratory support

Exclusion Criteria:

* Infants more than or equal to 33 weeks
* Preterm infants with congenital anomalies
* Infants on a non-conventional mode of invasive or non-invasive ventilation
B: Inclusion Criteria:

* Preterm infants with a gestational age (GA) at birth of 24 - 29+6/7 weeks
* Receiving invasive mechanical ventilation or non-invasive respiratory support (NCPAP or NIPPV)
* Receiving supplemental oxygen (defined as FiO2 ≥ 0.25) at the time of enrollment and for at least 18 hours during the previous 24 hours; Or a coefficient of variation in supplemental oxygen of ≥ 0.1 in the previous 24 hours.
* Expected to complete the 49-hour or 50-hour study period in the current form of respiratory support, i.e. invasive mechanical ventilation or non-invasive respiratory support
* Written informed parental consent must be present.

Exclusion Criteria:

* Major congenital anomalies
* Arterial hypotension requiring vasopressor therapy within 48 hours prior to enrollment.
* If the attending physician considers the infant not stable enough for a switch to another ventilator.
C: 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
D: Inclusion Criteria:

* Gestational age 23 0/7 - 27 6/7 weeks
* Postnatal age \< 24 hours

Exclusion Criteria:

* Infant not considered viable (decision made not to administer effective therapies)
* Dysmorphic features or congenital malformations that adversely affect life expectancy or neurodevelopment
* Known or strongly suspected cyanotic heart disease
* Persistent pulmonary hypertension, e.g. associated with pulmonary hypoplasia
* Unlikely to be available for long-term follow-up

Answer: C