To provide normative data and reference values for oxygen saturation and heart rate in healthy newborns the first 48 hours of life.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Neonatale transitie problematiek
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main endpoints are the distribution and percentile scores of oxygen
saturation and heart rate. Also the frequency and significance of desaturations
and episodes of bradycardia are main endpoints
Secondary outcome
The secondary objective of this study is to investigate the differences in
normal ranges of vital signs between newborns with differences in obstetric
history (i.e. caesarean delivery, small for gestational age, large for
gestational age, late prematurity) and between periods of feeding and
non-feeding.
Background summary
Pulse oximetry is frequently used in newborn care to monitor vital signs for
different reasons. Marked desaturations <92% or bradycardia <80 bpm are often
seen in term infants during monitoring, without obvious relation to the reason
of monitoring and without clinical consequence. In the literature little to no
studies describe reference values for continuous measurements of oxygen
saturation and heart rate in healthy term infants.
Study objective
To provide normative data and reference values for oxygen saturation and heart
rate in healthy newborns the first 48 hours of life.
Study design
Prospective cross-sectional study
Study burden and risks
The study requires for the study subjects to be connected to a monitoring
device using a sensor placed on the left arm or foot. No burden or adverse
events will be associated with participation. For the infants enrolled in this
study there is no added individual benefit. They do, however, participate in
setting normal values for future use in other infants.
Langendijk 75
Breda 4819 EV
NL
Langendijk 75
Breda 4819 EV
NL
Listed location countries
Age
Inclusion criteria
- Newborn infants in the first 6 hours of life
- Gestational age 35 weeks or above
Exclusion criteria
- Gestational age <35 weeks
- Medical indication for monitoring vital signs
- Any known cardiac or chromosomal defect
- Any (antenatally or postnatally) suspected cardiac defect
- Absence of written informed consent
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL54229.101.15 |