Automated Adjustment of Inspired Oxygen to Maintaining Regional Cerebral Oxygenation in Preterm Infants on Respiratory Support

Premature Infants Clinical Trial

Official title:

Effects of Automated Adjustment of the Inspired Oxygen in Reducing the Risk of Regional Cerebral (rSO2) Hypo-oxygenation in Preterm Infants on Non Invasive or Invasive Respiratory Support

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02748447
• Other study ID #: PoloU
• Status: Recruiting
• Phase: N/A
• First received: April 19, 2016
• Last updated: April 14, 2017
• Start date: April 2016
• Est. completion date: July 2017

Study information

• Verified date: April 2017
• Source: Ospedale L. Sacco – Polo Universitario
• Contact: Ilaria Stucchi, MF
• Phone: 00393358050962
• Email: stucchi.ilaria[@]icp.mi.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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 Study product:AVEA ventilator with closed-loop inspired oxygen control (CLiO2) automated FiO2 control option. An additional sensor will be attached to the infant's forehead for continuous measurement of cerebral tissue oxygen saturation (rStO2) with 5100C NIRS oximeter, Covidien.

Duration:24 hours each of manual control and CLiO2 control. Reference therapy:Manual control of FiO2 provided according to standardized guidelines.

Statistical Methodology: repeated measures mixed linear model with control from sequence and ventilation mode.

Concurrent safety oversight:Independent Data Safety Monitoring Board, with blinded review every 6 months or 50% enrollment, and after 15 subjects.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 7 Days

Eligibility

Inclusion Criteria:

• preterm infants of 25+0-28+6 weeks of gestational age, requiring invasive or non invasive respiratory support and supplemental oxygen

Exclusion Criteria:

• infants with major congenital anomalies, haemodinamic instability, or requiring cathecolamines treatment,clinical evidence of seizures or ongoing sepsis (positive blood culture) during the study, or within 24 hours prior enrollment

Related Conditions & MeSH terms

• Cerebrovascular Circulation
• Premature Infants

Intervention

Device:
• Automated FiO2 adjustment
AVEA ventilator according to SpO2 target range delivers an automated FiO2

Locations

Country	Name	City	State
Italy	V. Buzzi Childrens's Hospital - ASST FBF-SACCO	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale L. Sacco – Polo Universitario

Country where clinical trial is conducted

Italy, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	AUC above the individual median rStO2 and time (% of the total recording time) within the SpO2 target range (91-95%)	burden hyperoxemia	24 hours