To determine the feasibility of measuring SpO2 and HR by applying a pulse oximetry probe to the umbilical cord at birth in term neonates undergoing PBCC.
ID
Source
Brief title
Condition
- Other condition
- Neonatal and perinatal conditions
- Neonatal respiratory disorders
Synonym
Health condition
fysiologische neonatale transitie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome will be the proportion of infants who have a reliable
umbilical pulse oximetry signal acquisition within the first 60 seconds after
birth
Secondary outcome
Proportion of infants in whom the umbilical cord oximeter can be successfully
placed
Time from birth to sensor application
Time from sensor application to reliable signal acquisition
Time from birth to reliable signal acquisition
SpO2 (umbilical) at 2 second intervals during the first 10 min after birth
HR (umbilical) at 2 second intervals during the first 10 min after birth
Number of adverse events related to the umbilical cord
Background summary
Several studies have demonstrated the beneficial effects of delayed cord
clamping in infants at birth. This approach is therefore increasingly
implemented in clinical practice. Benefits associated with delayed cord
clamping are an increase haemoglobin, hematocrit and a reduction in the risk
for iron deficiency anaemia in the first year of life. These beneficial effects
have been attributed to the increase in neonatal blood volume from the placenta
(placental transfusion).
Heartrate and oxygen saturation are used for clinical evaluation of a newborn,
by placing a pulseoximeter sensor on the right hand of the newborn. It is
possible reliable signals can be obtained faster when placing the sensor on the
umbilical cord. However, it is yet to be determined if pulseoximeter
measurements obtained from the umbilical cord are both accurate and obtained
faster.
Study objective
To determine the feasibility of measuring SpO2 and HR by applying a pulse
oximetry probe to the umbilical cord at birth in term neonates undergoing PBCC.
Study design
Prospective, observational study
Study burden and risks
There are no risks associated with placing or using pulseoximeter sensors.
There is a theoretical risk of umbilical arterial vasospasm associated with
umbilical cord manipulation when the probe of the oximeter is applied around
the umbilicus. Umbilical arterial vasospasm is rarely (3%) observed during
invasive procedures9 (umbilical arterial catheterisation). In this study
measurements are however non-invasive where the sensor wrap is gently wrapped
around the umbilicus, to avoid traction or pressure on the umbilical cord.
Hence, the risk associated with umbilical oximeter application is likely to be
negligible.
Pulse oximetry is standardly used at birth in infants where clinical evaluation
is needed and sensors are specifically designd for (pre)term neonated. We do
not expect any other risks concerning the use of this device. The use of the
pulse oximeter will not interfere with contact between mother and child.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
Healthy infants born at Leiden University Medical Centre birth centre.
Gestational age of at least 37 weeks, of multiparous mothers
No need for resuscitation/respiratory support
Exclusion criteria
significant congenital malformations influencing the cardiopulmonary transition
signs of placental abruption or placenta praevia
signs of severe fetal distress necessitating an emergency caesarean section
infants needing respiratory support during transition as the cord will then be
clamped immediately
infants born via caesarean section
infants with short umbilical cords, that are unable to be placed at their
mothers chest
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
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 | NL70932.058.19 |