Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT03092661 |
| Other study ID # |
GN16RM676P |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
March 22, 2017 |
| Last updated |
July 6, 2017 |
| Start date |
March 27, 2017 |
| Est. completion date |
February 28, 2018 |
Study information
| Verified date |
July 2017 |
| Source |
NHS Greater Glasgow and Clyde |
| Contact |
Helen Mactier, MD |
| Phone |
+44 141 211 5249 |
| Email |
Helen.Mactier[@]ggc.scot.nhs.uk |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
To define preliminary reference (normative) limits for healthy, newborn baby oxygen
saturation parameters using the Masimo Radical 7® monitor.
To assess protocol feasibility in terms of acceptability to parents and infants.
To inform the design of a future larger study where reference limits will be fully defined
across a wider gestational age group.
Description:
Blood oxygen saturation is the percentage of haemoglobin carrying oxygen. It is accepted that
healthy term infants breathing room air have oxygen saturation levels of 95% or greater,
similar to adults (Levesque 2000). Blood oxygen saturation levels have to be carefully
balanced in infants who are born prematurely. High saturation levels are associated with
retinopathy of prematurity (ROP) and lower saturation levels with increased mortality
(SUPPORT 2010; BOOST II 2013).
Current practice is to maintain premature infants' oxygen saturations between 88 and 93%.
After 36 weeks' postmenstrual age, the risk of ROP is greatly reduced and these target oxygen
saturations are typically increased to greater than 93%. Lower saturations beyond this time
are associated with poor weight gain and are considered to carry a risk of developing
pulmonary hypertension (Poets 1998). Many of the smallest and most premature infants will
continue to require supplemental inspired oxygen after 36 weeks' postmenstrual age in order
to maintain saturations greater than 93%, so called "chronic lung disease of prematurity".
Some of these infants will require to be discharged home on supplemental oxygen. The need for
home oxygen is determined by measurement of pulse oximetry prior to discharge.
A recently developed device, the Masimo Radical 7, is now in widespread use in preterm
infants nearing discharge from the neonatal unit. This device is more accurate (Bohnhorst
2002), derives extra physiological measures from the oxygen saturation data (heart rate and
perfusion index) and offers longer-term data storage than other models currently in clinical
use. In addition, the Masimo Radical 7 with its analysis software is capable of counting and
measuring shorter-term dips in oxygen saturation (Sedowofia 2008). An oxygen saturation study
can be measured in terms of the overall oxygen saturation, and/or the number, duration and
severity of these dips. Increasing use of the Masimo Radical 7 to record oxygen saturation
studies in preterm infants nearing discharge from the neonatal unit has, for a significant
number of infants, revealed more than previously suspected episodes of reduced oxygen
saturation which are frequently not clinically apparent. Because of a dearth of data recorded
from healthy term babies in the immediate newborn period, the "normal" Masimo Radical 7 trace
is not well defined and the significance of these short dips in oxygen saturation is not
clear. Defining acceptable saturation limits depends on a complete understanding of what is
normal: in other words, deriving adequate reference limits from hundreds of healthy neonates
(CLSI 2008; Pan 1990).
Multiple studies of oxygen saturation levels in neonates have been conducted, but disparate
devices and protocols, and heterogeneity in age, gestation and morbidity of subjects preclude
any universal clinical decision limit for normal oxygen saturation profile in
prematurely-born neonates. Furthermore, as noted above, most currently-used oxygen saturation
monitors do not capture very short-term changes in oxygen saturation.
This study will define preliminary reference limits for pulse oximetry in newly born healthy
term babies, in order better to be able to interpret oxygen saturation recordings made in
preterm babies nearing term corrected age and hospital discharge. The investigators will
assess feasibility of data collection, and use the data to inform a subsequent larger study.
