Prolonged automatic oxygen support in preterm infants

Prolonged administration of closed-loop inspired oxygen support in preterm infants (Opticlio 2) A randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON27305

Enrollment

Registered

2017-10-04

Start date

2017-12-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hypoxemia, hyperoxemia, hypoxie, hyperoxie

Interventions

Infants enrolled in the study will randomly be assigned to either the A-FiO2 function when receiving non-invasive respiratory support from the ventilator with closed-loop or to the routine M-FiO2 func

Eligibility

Inclusion criteria

Inclusion criteria: Preterm infants will be enrolled based on the following inclusion criteria: • From day 7 of life after being born with a gestational age under 28 weeks • Impaired control of breathing (apnea) of at least 2 times / 8 hours, requiring an increase in FiO2 ≥ 20% • Written informed parental consent

Exclusion criteria

Exclusion criteria: • Major congenital anomalies • If the attending physician deems participation in the study is not in the best interest of the infant • No ventilator with A-FiO2 function available

Design outcomes

Primary

Measure	Time frame
The hypotheses of this trial are based on the need to assess the effectiveness of A-FiO2 adjustments over time. The primary outcome variable is therefore defined as the proportion of time for both control settings with SpO2 within the assigned saturation TR (87-95%), measured over a time period of maximum 28 days and excluding time with SpO2 above the range while FiO2 is set at 0.21.	—

Secondary

Measure	Time frame
1. The proportion of time in a)hypoxemia defined as SpO2 95% while FiO2 > 0.21 between different modes of control. This will also include the frequency of extreme episodes lasting longer than 1 minute with a) SpO2 98% while FiO2 > 0.21. The rationale for this is based on common clinical recommendations and large oxygen trials to minimize exposure to Prolonged administration of closed-loop inspired oxygen support in preterm infants (OptiClio 2)Prolonged administration of closed-loop inspired oxygen support in preterm infants both upper and lower ranges of oxygen saturation that can be associated with insufficient or excessive oxygen supplementation. 2. The distribution of SpO2 between the two different settings of control at consecutive days in time. This will specifically include the comparisons of the 5th, 25th, 50th, 75th, and 95th percentiles. This will be visualized in histograms per week. 3. The actual fraction of inspired oxygen between the two control settings calculated for the different days over time. For this, the mean, standard deviation and interquartile FiO2 will be calculated over each day and setting. 4. The total proportion of time with FiO2 at 0.21 for the two control settings. 5. The cumulative amount of oxygen administered over all study days. 6. The cumulative amount of oxygen administered on the final/28th day PNA. 7.The incidence of the clinical outcome BPD at 36 weeks PNA. 8. The total time of non-invasive respiratory support defined as nCPAP, nasal intermittent positive pressure ventilation (NIPPV) or heated humidified high flow nasal cannula (HHFNC) for the two control settings. 9. The frequency and duration of invasive respiratory support. 10. The variability of SpO2 between the two control settings. This will include the coefficient of variation (Standard deviation divided by the mean) of SpO2 over each recorded day. 11. The difference in total amount of doxapram dosage between the two control settings. 12. The frequency and du	—

Measure

Time frame

1. The proportion of time in a)hypoxemia defined as SpO2 95% while FiO2 > 0.21 between different modes of control. This will also include the frequency of extreme episodes lasting longer than 1 minute with a) SpO2 98% while FiO2 > 0.21. The rationale for this is based on common clinical recommendations and large oxygen trials to minimize exposure to Prolonged administration of closed-loop inspired oxygen support in preterm infants (OptiClio 2)Prolonged administration of closed-loop inspired oxygen support in preterm infants both upper and lower ranges of oxygen saturation that can be associated with insufficient or excessive oxygen supplementation. 2. The distribution of SpO2 between the two different settings of control at consecutive days in time. This will specifically include the comparisons of the 5th, 25th, 50th, 75th, and 95th percentiles. This will be visualized in histograms per week. 3. The actual fraction of inspired oxygen between the two control settings calculated for the different days over time. For this, the mean, standard deviation and interquartile FiO2 will be calculated over each day and setting. 4. The total proportion of time with FiO2 at 0.21 for the two control settings. 5. The cumulative amount of oxygen administered over all study days. 6. The cumulative amount of oxygen administered on the final/28th day PNA. 7.The incidence of the clinical outcome BPD at 36 weeks PNA. 8. The total time of non-invasive respiratory support defined as nCPAP, nasal intermittent positive pressure ventilation (NIPPV) or heated humidified high flow nasal cannula (HHFNC) for the two control settings. 9. The frequency and duration of invasive respiratory support. 10. The variability of SpO2 between the two control settings. This will include the coefficient of variation (Standard deviation divided by the mean) of SpO2 over each recorded day. 11. The difference in total amount of doxapram dosage between the two control settings. 12. The frequency and du

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Contacts

Public ContactW. Onland

Emma Childrens Hospital/AMC Department of Neonatology

w.onland@amc.uva.nl+31 (0)20 5669111

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)