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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05030337
Other study ID # 297749
Secondary ID KCH21-111
Status Recruiting
Phase N/A
First received
Last updated
Start date September 5, 2021
Est. completion date August 2024

Study information

Verified date March 2024
Source King's College Hospital NHS Trust
Contact Ourania Kaltsogianni, MSc
Phone (+44)02032999000
Email ourania.kaltsogianni@nhs.net
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Many premature infants require respiratory support in the newborn period. Mechanical ventilation although life-saving is linked to complications for the lungs and other organs and its duration should be kept to a minimum. The use of supplemental oxygen may also increase the risk of comorbidities such as retinopathy of prematurity. Therefore, oxygen saturation levels and the amount of inspired oxygen concentration provided should be continuously monitored. Oxygen control can be performed manually or with the use of a computer software incorporated into the ventilator that is called 'closed loop automated oxygen control'(CLAC). The software uses an algorithm that automatically adjusts the amount of inspired oxygen to maintain oxygen saturation levels in a target range. Evidence suggests that CLAC increases the time spent in the desired oxygen target range but there are no data to determine the effect on important clinical outcomes. A previous study has also demonstrated that CLAC reduces the inspired oxygen concentration more rapidly when compared to manual control. That could help infants come off the ventilator sooner. With this study we want to compare the time preterm infants spend on the ventilator when we use the software to automatically monitor their oxygen levels with those infants whose oxygen is adjusted manually by the clinical team. That could help us understand if the use of automated oxygen control reduces the duration of mechanical ventilation and subsequently the complications related to it.


Description:

This will be a randomised controlled trial. The investigators aim to recruit a minimum of seventy premature ventilated infants born at less than 31 weeks gestation. Participants will be randomised to either closed-loop automated oxygen control or manually controlled oxygen from recruitment to successful extubation. The investigators will also record basic epidemiologic parameters and associated comorbidities that may impact on the duration of mechanical ventilation. Infants with known congenital anomalies will be excluded from the study. Informed written consent will be requested from the parents or legal guardians of the infants and the attending Neonatal Consultant will be requested to assent to the study. Eligible infants whose parents consent to the study will be enrolled within 48 hours of initiation of mechanical ventilation. Randomisation will be performed using an online randomisation generator. Patients will be ventilated using SLE6000 ventilators. Ventilation settings will be manually adjusted by the clinical team as per unit's protocol. The intervention group, in addition to standard care will be also connected to the OxyGenie closed-loop oxygen saturation monitoring software (SLE). This software uses oxygen saturations from the SpO2 probe attached to the neonate, fed into an algorithm, to automatically adjust the percentage of inspired oxygen to maintain oxygen saturations within the target range. Manual adjustments including the percentage of FiO2 will be allowed at any point during the study if deemed appropriate by the clinical team. The nurse-to-patient ratio will be according to the unit's protocol that is determined on the patient's acuity. Patients will be studied from enrolment until successful extubation. If an infant fails extubation and requires reintubation within 48 hours, he will be studied in his initial arm if less than 28 days old. Therefore, for those infants randomised at the intervention group CLAC will resume. Preterm infants that remain ventilated beyond day 28 of life will continue at their study arm (closed-loop automated oxygen control or manual oxygen control) till their first extubation attempt.


Recruitment information / eligibility

Status Recruiting
Enrollment 70
Est. completion date August 2024
Est. primary completion date August 2024
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Closed-loop automated oxygen control (Oxygenie, SLE 6000)
The OxyGenie closed-loop oxygen saturation monitoring software (SLE) uses oxygen saturations from the SpO2 probe attached to the neonate, fed into an algorithm, to automatically adjust the percentage of inspired oxygen to maintain oxygen saturations within the target range. Manual adjustments including the percentage of FiO2 will be allowed at any point during the study if deemed appropriate by the clinical team.

Locations

Country Name City State
United Kingdom King's College Hospital NHS Foundation Trust London

Sponsors (2)

Lead Sponsor Collaborator
King's College Hospital NHS Trust King's College London

Country where clinical trial is conducted

United Kingdom, 

References & Publications (11)

Dani C. Automated control of inspired oxygen (FiO2 ) in preterm infants: Literature review. Pediatr Pulmonol. 2019 Mar;54(3):358-363. doi: 10.1002/ppul.24238. Epub 2019 Jan 10. — View Citation

Di Fiore JM, Bloom JN, Orge F, Schutt A, Schluchter M, Cheruvu VK, Walsh M, Finer N, Martin RJ. A higher incidence of intermittent hypoxemic episodes is associated with severe retinopathy of prematurity. J Pediatr. 2010 Jul;157(1):69-73. doi: 10.1016/j.jpeds.2010.01.046. Epub 2010 Mar 20. — View Citation

Dimitriou G, Greenough A, Endo A, Cherian S, Rafferty GF. Prediction of extubation failure in preterm infants. Arch Dis Child Fetal Neonatal Ed. 2002 Jan;86(1):F32-5. doi: 10.1136/fn.86.1.f32. — View Citation

Ford SP, Leick-Rude MK, Meinert KA, Anderson B, Sheehan MB, Haney BM, Leeks SR, Simon SD, Jackson JK. Overcoming barriers to oxygen saturation targeting. Pediatrics. 2006 Nov;118 Suppl 2:S177-86. doi: 10.1542/peds.2006-0913P. — View Citation

Greenough A. Long-term respiratory consequences of premature birth at less than 32 weeks of gestation. Early Hum Dev. 2013 Oct;89 Suppl 2:S25-7. doi: 10.1016/j.earlhumdev.2013.07.004. Epub 2013 Jul 30. — View Citation

Hagadorn JI, Furey AM, Nghiem TH, Schmid CH, Phelps DL, Pillers DA, Cole CH; AVIOx Study Group. Achieved versus intended pulse oximeter saturation in infants born less than 28 weeks' gestation: the AVIOx study. Pediatrics. 2006 Oct;118(4):1574-82. doi: 10.1542/peds.2005-0413. — View Citation

Hunt KA, Dassios T, Ali K, Greenough A. Prediction of bronchopulmonary dysplasia development. Arch Dis Child Fetal Neonatal Ed. 2018 Nov;103(6):F598-F599. doi: 10.1136/archdischild-2018-315343. Epub 2018 Jun 12. No abstract available. — View Citation

Sink DW, Hope SA, Hagadorn JI. Nurse:patient ratio and achievement of oxygen saturation goals in premature infants. Arch Dis Child Fetal Neonatal Ed. 2011 Mar;96(2):F93-8. doi: 10.1136/adc.2009.178616. Epub 2010 Oct 30. — View Citation

Sturrock S, Ambulkar H, Williams EE, Sweeney S, Bednarczuk NF, Dassios T, Greenough A. A randomised crossover trial of closed loop automated oxygen control in preterm, ventilated infants. Acta Paediatr. 2021 Mar;110(3):833-837. doi: 10.1111/apa.15585. Epub 2020 Oct 6. — View Citation

Sturrock S, Williams E, Dassios T, Greenough A. Closed loop automated oxygen control in neonates-A review. Acta Paediatr. 2020 May;109(5):914-922. doi: 10.1111/apa.15089. Epub 2019 Nov 27. — View Citation

Vliegenthart RJS, van Kaam AH, Aarnoudse-Moens CSH, van Wassenaer AG, Onland W. Duration of mechanical ventilation and neurodevelopment in preterm infants. Arch Dis Child Fetal Neonatal Ed. 2019 Nov;104(6):F631-F635. doi: 10.1136/archdischild-2018-315993. Epub 2019 Mar 20. — View Citation

* Note: There are 11 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary The duration of mechanical ventilation The duration of mechanical ventilation will be measured in median (interquartile range) number of days of ventilation for participants in each group. Through study completion, an average of 2 years
Secondary The percentage of time spent within target oxygen saturation range. Target oxygen saturation range for our preterm population is 90-95% as per local guideline. The time spent in target range will be calculated as a percentage of the total time of monitoring. Through study completion, an average of 2 years
Secondary Number of manual adjustments to the inspired oxygen concentration required by clinical staff. The number of manual adjustment will be calculated by reviewing the infant's medical records. Through study completion, an average of 2 years
Secondary Number of days on oxygen. The number of days each participant will require supplementary oxygen to maintain oxygen saturation levels within target range. Through study completion, an average of 2 years
Secondary Length of Intensive Care stay The days each participant is admitted at the Neonatal Intensive Care Through study completion, an average of 2 years
Secondary A diagnosis of bronchopulmonary dysplasia (BPD) at 36 weeks postmenstrual age The diagnosis of BPD will be calculated by reviewing the infant's medical records and respiratory status. Through study completion, an average of 2 years
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