To determine the feasibility of umbilical PO for HR measurements after cord clamping in infants needing stabilization at birth and to compare this with standard PO on the right hand.
ID
Source
Brief title
Condition
- Neonatal respiratory disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The time needed to obtain an accurate HR signal after sensor placement. An
accurate signal will be defined as a stable display of HR with a good
plethysmograph signal, without *low signal* alarms.
Secondary outcome
* Proportion of infants in whom the PO sensor can successfully be placed on the
umbilical cord.
* Proportion of infants with an accurate HR signal.
* HR (umbilical and right hand ) at 2 second intervals during the first 10 min
after birth.
Background summary
Approximately 10% of all newborn infants fail to adapt from fetal to neonatal
life after birth, and require additional respiratory support for
cardiopulmonary stabilization. At birth, heart rate is the most important
indicator used to evaluate the clinical condition of newborns. Subsequently,
adequate monitoring of this parameter is needed to successfully guide
interventions needed for stabilization.
The standard procedure for evaluating heart rate in newborn infants is pulse
oximetry measured at the right hand (pre-ductal). However, several studies have
shown that pulse oximetry measurements obtained at the right hand are often
inaccurate in the first minutes. Umbilical pulse oximetry might lead to faster
and more accurate heart rate measurements, but this has so far not been tested.
Umbilical pulse oximetry will only be clinically useful when accurate heart
rate measurements can be obtained faster than pulse oximetry on the right hand.
We hypothesize that it is feasible to measure heart rate using umbilical pulse
oximetry after cord clamping in newborns needing stabilization at birth, and
that accurate heart rate measurements will be obtained faster when compared to
measurements obtained at the right hand.
Study objective
To determine the feasibility of umbilical PO for HR measurements after cord
clamping in infants needing stabilization at birth and to compare this with
standard PO on the right hand.
Study design
Prospective observational study.
Study burden and risks
The are no risks associated with participation in this study. The sensors used
in this study are specifically designed for preterm born infants and will be
gently wrapped around the base of the umbilicus (where the umbilicus is still
covered with skin epithelial). Local NICU protocol states that sensors should
be renewed and relocated every four hours. Sensors in this study will only be
placed during a maximum time of 10 minutes, therefore we do not expect any
risks concerning the use of this device.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
Infants born between 26-42 weeks gestational age where stabilisation at birth
is anticipated.
Exclusion criteria
Infants participating in the ABC3 trial, who are randomized to physiological
based cord clamping and are stabilised on the Concord resuscitation table.
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| CCMO | NL72220.058.19 |