To assess the accuracy and cost-effectiveness of PO screening for CCHD in the Dutch perinatal care system.
ID
Source
Brief title
POLAR study
Condition
- Congenital cardiac disorders
- Cardiac and vascular disorders congenital
- Neonatal respiratory disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
In this study the primary end point will be the accuracy of PO screening for
CCHD. The accuracy is embodied in the sensitivity, specificity, false positive
rate, false negative rate, positive and negative predictive value.
Secondary outcome
Cost-effectiveness
Problems identified in the use of PO in home setting
Problems identified with referral logistics
Other pathology detected with screening with PO
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 critical CHD (CCHD) in
both pre- and postnatal period is vital for
the prognosis. Despite antenatal echocardiography screening and physical
examination after birth , CCHD 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. The feasibility of PO
screening in the Dutch system was proved in a feasibility study in Leiden. A
larger implementation study is needed to assess the accuracy and
cost-effectiveness of PO screening for CCHD.
Study objective
To assess the accuracy and cost-effectiveness of PO screening for CCHD in the
Dutch perinatal care system.
Study design
Prospective, non-randomized implementation study
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 infants born in the Amsterdam-Leiden region
Exclusion criteria
pre and post ductal pulse oximetry measurements for monitoring;
Ecocardiographie performed post natally
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 | NL51644.058.14 |