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ID
Source
Brief title
Health condition
hypoxemia, hyperoxemia, hypoxie, hyperoxie
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
1. The proportion of time in a)hypoxemia defined as SpO2 <88% and b) hyperoxemia 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 < 80% and b) 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 duration of episodes with SpO2 below the intended range between the two modes of control. This will specifically include the frequency and duration of episodes with SpO2 below the range (<70%, <80%, 80-88%).
13. The proportion of time with SpO2 below the intended range between the two modes of control. This will specifically include the proportion of time with SpO2 below the range (<70%, <80%, 80-88%).
14. The frequency and duration of episodes with SpO2 above the intended range between the two modes of control. This will specifically include the frequency and duration of episodes with SpO2 above the range (>95%, >98%). These will include only episodes while FiO2 > 0.21.
15. The proportion of time with SpO2 above the intended range between the two modes of control. This will specifically include the frequency and duration of episodes with SpO2 above the range (>95%, >98%). These will include only episodes while FiO2 > 0.21.
16. Influence of A-FiO2 and M-FiO2 on the respiratory control and respiratory stability, monitored by measuring the electrical activity of the diaphragm transcutaneously (dEMG) at the start of the study and followed-up every week as long as the infant participates in the study.
Background summary
Rationale: Preterm infants often require supplemental oxygen to prevent hypoxemia, a condition that has been associated with organ damage and an increased mortality. However, too much oxygen supplementation resulting in hyperoxemia may lead to systemic oxidative damage and long-term complications such as retinopathy of prematurity (ROP). For these reasons, oxygen saturation is continuously measured in preterm infants with pulse oximetry (SpO2) aiming to keep it within a safe target range (TR) by manually titrating the fraction of inspired oxygen (FiO2). However, studies in preterm infants have shown that SpO2 targeting is a clinical challenge with patients spending only 50% of the time within their SpO2 TR, due to clinical instability and the limited time nurses have to adjust the amount of oxygen. Newly developed techniques incorporated in the ventilator provide the opportunity of automated FiO2 control (A-FiO2). Only short term studies (days) have investigated the A-FiO2 function and long term effects need to be evaluated. The short term studies indicate that this closed-loop A-FiO2 reduces time outside the TR, decreases number and duration of hypo- and hyperoxemic episodes, and reduces caregivers’ workload compared to manual FiO2 control (M-FiO2).
Objective: To assess the effectiveness of continuous, long term (weeks) use of a closed-loop FiO2 control system in comparison with M-FiO2 control in preterm infants with non-invasive respiratory support.
Study design: Randomised controlled trial.
Study population: Preterm infants treated in a level III NICU.
Intervention: In order to study the effectiveness over a longer period of time of the A-FiO2 function of the ventilator, preterm infants will be set at random to either continuous use of the A-FiO2 function or to continuous use of M-FiO2 control from first week of life till the 28th day of life.
Study objective
Preterm infants often require supplemental oxygen to prevent hypoxemia and hyperoxemia. Conditions that have been associated with organ damage and an increased mortality. Newly developed techniques incorporated in the ventilator provide the opportunity of automated FiO2 control (A-FiO2). 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 range (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.
Study design
Not applicable
Intervention
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 function by the nurses when receiving non-invasive respiratory support. Duration of the intervention per patient will be from randomization to 28 days of age.
Department of Neonatology
W. Onland
Meibergdreef 9
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5669111
w.onland@amc.uva.nl
Department of Neonatology
W. Onland
Meibergdreef 9
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5669111
w.onland@amc.uva.nl
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
• 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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6543 |
| NTR-old | NTR6731 |
| Other | : METC 2017_222 |