Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized Cross-over Trial in the Effect of Automated Oxygen Control Devices on the Distribution of Oxygen Saturation in Preterm Infants
Brief Summary: Premature infants often receive respiratory support and supplemental oxygen for a prolonged period of time during their admission in the NICU. While maintaining the oxygen saturation within a narrow target range is important to prevent morbidity, manual oxygen titration can be very challenging. Automatic titration by a controller has been proven to be more effective. However, to date the performance of different controllers has not been compared. The proposed randomized crossover trial Comparing Oxygen Controllers in Preterm InfanTs (COCkPIT) is designed to compare the effect on time spent within target range. The results of this trial will help determining which algorithm is most successful in controlling oxygen, improve future developments in automated oxygen control and ultimately reduce the morbidity associated with hypoxemia and hyperoxemia.


Options:
A: Inclusion Criteria:

* postmenstrual age \<30 wks GA at study time
* on nasal/nasopharyngeal CPAP or mechanical ventilation (including nasopharyngeal IMV)
* at least 4 desaturations (SpO2 \<80%) during an 8 hour period within the 24h before the study using a standard pulse oximeter incorporated in the NICU (Dash 3000, General Electric, Freiburg; 10s averaging time, delay 10s)

Exclusion Criteria:

* postnatal age \<96h (to exclude rapidly changing conditions during the early phase of RDS and to avoid handling of the infant during the critical period for IVH)
* congenital cyanotic heart disease
* no decision for full treatment support
* Average FiO2 during the last 24h bevor the active study phase \>0.60
* Congenital malformations of the lung or the diaphragm (i.e. diaphragmatic hernia, congentital cystic lung diseases...)
* Clinically clear evidence for seizures
* Ongoing Sepsis (CRP \> 10mg/l, or positive blood culture, requirement of catecholamines)
* Need of blood-transfusion during study
B: Inclusion Criteria:

1. Preterm infants being treated with high flow nasal cannula therapy
2. A need for supplemental oxygen as demonstrated by an required FiO2 \> 0.25 at enrollment
3. Requiring a flow rate of greater than 2 L/min such that the assumed inspired oxygen fraction matched delivered oxygen fraction (definition of HFNC).

Exclusion Criteria:

1. Major congenital abnormalities
2. Hemodynamic instability, defined as being outside of a normotensive range based on each infant's individual characteristics
3. Seizures
4. Ongoing sepsis
5. Meningitis
6. Clinician's concern regarding stability of the infant
C: 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.
D: Inclusion Criteria:

* Preterm infants less than 31 weeks completed gestation at birth requiring mechanical ventilation and admitted to King's NICU in the first 48 hours after birth

Exclusion Criteria:

* Preterm infants above 31 weeks completed gestation or term born infants
* Infants with major congenital abnormalities

Answer: C