The feasibility and safety of the use of automated oxygen in babies admitted to the neonatal intensive care unit
| ISRCTN | ISRCTN47204932 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN47204932 |
| Secondary identifying numbers | NL51887.000.16 |
- Submission date
- 18/10/2021
- Registration date
- 28/10/2021
- Last edited
- 09/12/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
Background and study aims
As both excess and shortage of oxygen can be harmful to a baby born prematurely (before the usual end of pregnancy) we investigate whether it is possible to use automated oxygen control and if this is better than manual control of oxygen by a nurse or other healthcare provider.
Who can participate?
Preterm babies admitted to one of the participating Neonatal Intensive Care Units (NICU), requiring respiratory support and extra oxygen can participate.
What does the study involve?
The study involves a control period of 8 hours on manual control of oxygen, followed by a study period where automated oxygen control is turned on but still supervised by the nurse that takes care of the baby. After this period another control period of 8 hours on manual control follows. During the study period, the baby's oxygen levels are continuously monitored.
What are the possible benefits and risks of participating?
Due to the short study period and the continuous monitoring why expect no benefits or harm for the baby.
Where is the study run from?
Erasmus MC/Sophia's Children's Hospital (The Netherlands)
When is the study starting and how long is it expected to run for?
August 2016 to January 2020
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
K.P. Dijkman, k.dijkman@mmc.nl
Contact information
Scientific
De Run 4600
Veldhoven
5504DB
Netherlands
 ORCID ID |
0000-0003-0765-929X |
|---|---|
| Phone | +31 40 8889350 |
| k.dijkman@mmc.nl |
Study information
| Study design | Multicenter inteventional crossover feasibility study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | 40560 PIS.pdf |
| Scientific title | Safety and feasibility of Predictive Intelligent Control of Oxygenation (PRICO) on the Neonatal Intensive Care Unit (NICU) |
| Study objectives | Fully automated FiO2 control conducted by this algorithm will keep SpO2 within a predefined target range more time and with less deviation than during routine standard clinical care. |
| Ethics approval(s) | Approved 02/08/2016, CCMO: Central Committee on Research Involving Human Subjects (Mailbox 16302, 2500BH The Hague, The Netherlands; +31 70 340 67 00; ccmo@ccmo.nl), ref: NL51887.000.16 |
| Health condition(s) or problem(s) studied | Preterm newborns with oxygen requirement |
| Intervention | Newborns on respiratory support requiring oxygen wil be subjected to an 8 hour study period of automated control of oxygen with the PRICO algorithm that is used to control O2 on the Fabian HFO ventilator (Acutronic Meical GmbH, Hirzel, Switzerland). The 8 hour study period is flanked by two 8 hour periods of routine manual control of oxygen which is the current stand of care. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Respiratory support |
| Primary outcome measure | Time spent within the SpO2 target range measured using a pulse oximeter and logged at 1/s interval both during the study and during the control periods |
| Secondary outcome measures | Time spent below target range, time spent above target range, average FiO2 and SpO2 measured using a pulse oximeter and logged at 1/s interval both during the study and during the control periods |
| Overall study start date | 02/08/2016 |
| Completion date | 01/01/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | 25 |
| Total final enrolment | 32 |
| Key inclusion criteria | Newborns receiving respiratory support and a FiO2 moor than 21% while having an FiO2 of 95% or less and no plans to chnage ventilation mode during the next 24 hours |
| Key exclusion criteria | 1. Major congenital of chromosomal defects 2. Plans to transfer the patient out within 24 hours 3. Plans to change ventilation mode within 24 hours |
| Date of first enrolment | 27/09/2016 |
| Date of final enrolment | 27/12/2019 |
Locations
Countries of recruitment
- Netherlands
Study participating centres
Rotterdam
3015CN
Netherlands
Veldhoven
5504DB
Netherlands
Sponsor information
Hospital/treatment centre
Wytemaweg 80
Rotterdam
3015CN
Netherlands
| Phone | +31 10 703 6077 |
|---|---|
| i.reiss@erasmusmc.nl | |
| Website | http://www.erasmusmc.nl/sophia/ |
"ROR" |
https://ror.org/047afsm11 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/01/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a peer-reviewed Journal |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 28/10/2021 | No | Yes | ||
| Protocol file | 01/10/2015 | 28/10/2021 | No | No | |
| Results article | Primary data | 08/12/2022 | 09/12/2022 | Yes | No |
Additional files
Editorial Notes
09/12/2022: Publication reference was added and the final was changed from 33 to 32.
28/10/2021: Trial's existence confirmed by Central Committee on Research Involving Human Subjects.
