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Implementatiestudie screening op aangeboren hartafwijkingen in Nederland

Pulse Oximetry screening Leiden Amsterdam Region

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON25440
Enrollment
20000
Registered
2014-10-06
Start date
2015-05-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical congenital heart defects Potential threatening pathology causing hypoxemia in the neonate, such as persistent pulmonary hypertension, infection or sepsis.

Interventions

Pulse oximetry reading at least one hour after birth at right hand and either foot. Pulse oximetry reading at day two or three at right hand and either foot.

Sponsors

Leiden University Medical Center
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Infants born in the Amsterdam-Leiden region.

Exclusion criteria

Exclusion criteria: Infants where pre and post ductal pulse oximetry is performed for at least 24 hours for monitoring.

Design outcomes

Primary

MeasureTime frame
Accuracy of the screening for critical congenital heart defects: sensitivity, specificity, false positive rate, positive predictive value, negative predictive value.

Secondary

MeasureTime frame
Cost-effectiviness of the screening; Detection of other possible life threatening pathology, such as persistent pulmonary hypertension of the newborn, infection, sepsis, non-critical congenital heart defects; Problems identified in the use of PO in home setting; Problems identified with referral logistics

Contacts

Public ContactI. Narayen

Neonatologie, Postzone J6-S, Leiden University Medical Center

i.c.narayen@lumc.nl63183

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)