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Background: fluctuation of cerebral blood flow and oxygenation in neonates who undergo intensive care is an important risk factor for risk of neurodevelopmental impairment. Near infrared spectroscopy (NIRS) allow direct measurements of cerebral tissue oxygenation. Automated Fraction of Inspired Oxygen (FiO2) adjustment can maintain arterial oxygen saturation (SpO2) within a target range and may reduce risk of fluctuation of cerebral oxygenation.
Aim of this study: to evaluate the efficacy of automated FiO2 adjustment in maintaining SpO2 within a target range and in reducing the risk of cerebral tissue hypo-oxygenation due to SpO2 fluctuations in preterm infants on invasive or non invasive respiratory support with supplemental oxygen.
Background: fluctuation of cerebral blood flow and oxygenation in neonates who undergo intensive care is an important risk factor for risk of neurodevelopmental impairment. Near infrared spectroscopy (NIRS) allow direct measurements of cerebral tissue oxygenation. Automated FiO2 adjustment can maintain arterial oxygen saturation (SpO2) within a target range and may reduce risk of fluctuation of cerebral oxygenation.
Aim of this study: to evaluate the efficacy of automated FiO2 adjustment in maintaining SpO2 within a target range and in reducing the risk of cerebral tissue hypo-oxygenation due to SpO2 fluctuations in preterm infants on invasive or non invasive respiratory support with supplemental oxygen.
Methodology: multicenter randomized cross-over clinical trial. The study will be carried out for almost 1 year .
Study centers: 7 Italian Neonatal Intensive Care Units (NICUs) Number of subjects: 60 infants to have a >90% power, with an alpha of p=0.01, of detecting a 5% difference in %-time in the target range and a 50% difference in both SpO2 hyperoxic and hypoxic %-time.
Diagnosis and main inclusion criteria: preterm infants of 25+0-28+6 weeks of gestational age, requiring invasive or non invasive respiratory support and supplemental oxygen.
Other enrollment requirements: All infants will be enrolled between >72 hours (end of transition period) and \
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A-FiO2 | Experimental | 24 hours in automated FiO2 adjustment to maintain SpO2 within a target range |
|
| M-FiO2 | No Intervention | 24 hours in manual adjustment of FiO2 to maintain SpO2 within a target range |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Automated FiO2 adjustment | Device | AVEA ventilator according to SpO2 target range delivers an automated FiO2 |
|
| Measure | Description | Time Frame |
|---|---|---|
| the burden of hypoxemia on regional cerebral saturation (rStO2) calculated as area under curve (AUC-% second) below the individual median rStO2 range ( defined as +/-5% of the individual rStO2 median of each infant during each period | burden of hypoxemia on rStO2 | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| AUC above the individual median rStO2 and time (% of the total recording time) within the SpO2 target range (91-95%) | burden hyperoxemia | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ilaria Stucchi, MF | Contact | 00393358050962 | stucchi.ilaria@icp.mi.it |
| Name | Affiliation | Role |
|---|---|---|
| Gianluca Lista, MD | ASST-FBF-Sacco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| V. Buzzi Childrens's Hospital - ASST FBF-SACCO | Recruiting | Milan | 20154 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19299799 | Result | Kurth CD, McCann JC, Wu J, Miles L, Loepke AW. Cerebral oxygen saturation-time threshold for hypoxic-ischemic injury in piglets. Anesth Analg. 2009 Apr;108(4):1268-77. doi: 10.1213/ane.0b013e318196ac8e. | |
| 16598294 | Result | Laptook AR, Salhab W, Allen J, Saha S, Walsh M. Pulse oximetry in very low birth weight infants: can oxygen saturation be maintained in the desired range? J Perinatol. 2006 Jun;26(6):337-41. doi: 10.1038/sj.jp.7211500. |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| 19595375 | Result | Claure N, D'Ugard C, Bancalari E. Automated adjustment of inspired oxygen in preterm infants with frequent fluctuations in oxygenation: a pilot clinical trial. J Pediatr. 2009 Nov;155(5):640-5.e1-2. doi: 10.1016/j.jpeds.2009.04.057. |
| 26144575 | Result | van Kaam AH, Hummler HD, Wilinska M, Swietlinski J, Lal MK, te Pas AB, Lista G, Gupta S, Fajardo CA, Onland W, Waitz M, Warakomska M, Cavigioli F, Bancalari E, Claure N, Bachman TE. Automated versus Manual Oxygen Control with Different Saturation Targets and Modes of Respiratory Support in Preterm Infants. J Pediatr. 2015 Sep;167(3):545-50.e1-2. doi: 10.1016/j.jpeds.2015.06.012. Epub 2015 Jul 2. |
| D000091642 | Urogenital Diseases |