To investigate whether it is feasible to perform a large national implementation study in which community based midwives in the Netherlands use a pulse oximeter for screening newborns for CHD.
ID
Source
Brief title
Condition
- Congenital cardiac disorders
- Cardiac and vascular disorders congenital
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
the percentage of low risk infants that was screened for congenital heart
disease using pulse oximetry
Secondary outcome
problems identified in use of PO in home setting, problems identified with
referral logistics, sensitivity, specificity, positive and negative predictive
value of the screening method, the percentage of false positive referrals,
other pathology found with the screening, acceptability for mothers
Background summary
Congenital heart disease (CHD) is the most common group of congenital
malformations and is a leading cause of infant death in the developed world.
Early detection of severe CHD (SCHD) in both pre- and postnatal period is vital
for the prognosis. Despite antenatal echocardiography screening and physical
examination after birth , SCHD is still often missed. Pulse Oximetry (PO) has
now been recommended by the American Association of Pediatrics as a screening
tool for cyanotic CHD in low risk infants after birth. However, the perinatal
care for low-risk infants is unique as deliveries are supervised by
community-based midwives where the births take place at home, in a birth clinic
or in hospital. This accounts for approximately 30% of all deliveries.
Besides of the logistic challenge, it remains uncertain whether in the
Netherlands similar benefits and false positive referrals of CHD screening
could be anticipated and if it weighs against the costs of providing all
midwives with a pulse oximeter.
Study objective
To investigate whether it is feasible to perform a large national
implementation study in which community based midwives in the Netherlands use a
pulse oximeter for screening newborns for CHD.
Study design
prospective non-randomized feasibility study
Intervention
Pre ductal (right hand) and post ductal (right foot) pulse oximetry 1 hour post
delivery.
When saturation is lower than 90% the screening test is considered positive. If
the saturation is between 90 en 95% and/or the difference between pre and post
ductal saturation is more than 3%, the screening test will be repeated after
one hour. If the saturation is <95% and/or the difference between pre and post
ductal saturation is more than 3% at that measurement, the screening is
considered positive.
When saturation is 95% or higher and the difference between pre and post
ductal saturation is 3% or less, the screening test will be repeated at day 2
or 3 of the infant's life. If the saturation is 95% or higher and the
difference between pre and post ductal saturation is 3% or less at that last
measurement, the screening is considered negative and there will be no
interventions.
In case of a positive screening the infant will be referred to the Leiden
University Medical Center (LUMC) on the same day. In the LUMC physical
examination and, in case of persistant hypoxia, an echocardiography will be
done by a pediatrician/neonatologist and pediatric cardiologist.
Study burden and risks
No expected risks for the neonates
Possible burden: increased distress in parents and/or midwives supervising
births caused by false-positive referrals
Albinusdreef 2
Leiden 2333ZA
NL
Albinusdreef 2
Leiden 2333ZA
NL
Listed location countries
Age
Inclusion criteria
All term infants born in regio Leiden in period of 01-10-2013 to 30-09-2014
Exclusion criteria
Pulse oximetry monitoring as part of the care during admittance in hospital
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
CCMO | NL45190.058.13 |
OMON | NL-OMON26133 |