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

Comparative analysis of the clinical effectiveness for capillary blood sampling in preterm newborns of gestational age below 37 weeks or preterm newborns of body weight over 1500gm: laser lancing device versus automatic incision device. Randomized, Non-inferiority study.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0010932

Enrollment

Registered

2025-08-22

Start date

2021-04-19

Completion date

Unknown

Last updated

2025-11-10

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: - Premature babies born less than 37 weeks of pregnancy who were admitted to the neonatal intensive care unit of Korea University Ansan Hospital or premature babies weighing 1,500g or more when collecting blood. - If capillary blood gas analysis or bilirubin test is required for more than two consecutive days due to heel puncture. - Case where a clinical hemodynamic condition capable of collecting capillary blood with heel puncture is confirmed. - In the case where the parents of the study subjects voluntarily signed the consent form,

Exclusion criteria

Exclusion criteria: - In the case of diseases that affect peripheral vascular filling time due to unstable hemodynamic conditions such as congenital deep deformity or severe breathing difficulties (during artificial respiratory treatment), - If a blood test is not required. - Newborn babies with a pregnancy period of 37 weeks or more or premature infants weighing 1,500 g or less when collecting blood.

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 ContactChul Kyu Yoon

Korea University Ansan Hospital

gregorioyoon@hanmail.net+82-31-412-5551

Outcome results