Comparative analysis of the clinical effectiveness for capillary blood sampling in term newborns: laser lancing device versus automatic incision device.

Comparative analysis of the clinical effectiveness for capillary blood sampling in term newborns: laser lancing device versus automatic incision device. Randomized, Non-inferiority study.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0004901

Enrollment

Registered

2020-04-08

Start date

2020-06-09

Completion date

Unknown

Last updated

2021-11-02

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

Conditions

None listed

Interventions

Medical Device : Groups A and B are randomly assigned to the infants who meet the selection criteria of this study before starting the study. Put notes from group A and group B in an invisible envelop

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Full term neonate admitted to Korea University Ansan Hospital. - When capillary blood gas analysis or bilirubin examination is required for more than two consecutive days - Clinical hemodynamic conditions have been identified to allow capillary blood to be collected with the heel sampling - If the parents of the study participants voluntarily sign the informed consent

Exclusion criteria

Exclusion criteria: - In case of an unstable hemodynamic condition, such as congenital heart disease or severe respiratory difficulty, which affects the time of capillary refill - If no blood test is required - Premature babies under 37 weeks of pregnancy

Design outcomes

Primary

Measure	Time frame
Efficacy of blood sampling and pain score assesment	—

Secondary

Measure	Time frame
The skin damage caused by sampling	—

Countries

Korea, Republic of

Contacts

Public ContactEui Kyung Choi

Korea University Ansan Hospital

ekchoi33@gmail.com+82-31-412-5551

Outcome results