NCT02748447

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

April 19, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 22, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

April 17, 2017

Status Verified

April 1, 2017

Enrollment Period

1.1 years

First QC Date

April 19, 2016

Last Update Submit

April 14, 2017

Conditions

Cerebrovascular CirculationPremature Infants

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • AUC above the individual median rStO2 and time (% of the total recording time) within the SpO2 target range (91-95%)

    24 hours

Study Arms (2)

A-FiO2

EXPERIMENTAL

24 hours in automated FiO2 adjustment to maintain SpO2 within a target range

Device: Automated FiO2 adjustment

M-FiO2

NO INTERVENTION

24 hours in manual adjustment of FiO2 to maintain SpO2 within a target range

Interventions

Automated FiO2 adjustmentDEVICE

AVEA ventilator according to SpO2 target range delivers an automated FiO2

A-FiO2

Eligibility Criteria

Age72 Hours - 7 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

V. Buzzi Childrens's Hospital - ASST FBF-SACCO

Milan, 20154, Italy

RECRUITING

Related Publications (4)

  • 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.

    PMID: 19299799RESULT

  • 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.

    PMID: 16598294RESULT

  • 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.

    PMID: 19595375RESULT

  • 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.

    PMID: 26144575RESULT

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Gianluca Lista, MD

    ASST-FBF-Sacco

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ilaria Stucchi, MF

CONTACT

00393358050962stucchi.ilaria@icp.mi.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 19, 2016

First Posted

April 22, 2016

Study Start

April 1, 2016

Primary Completion

May 1, 2017

Study Completion

July 1, 2017

Last Updated

April 17, 2017

Record last verified: 2017-04

Locations

IT(1)