Analgesic Effect of Low Level Laser for Procedural Pain in Newborn Infants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

123 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-01

Study Completion Date

2019-12-31

Brief Summary

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Neonates undergo several painful procedures and these pain experiences can alter clinical outcome and behavior. The investigators aim to investigate the analgesic effect of low level laser for procedural pain during heel lancing of term neonates.

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Detailed Description

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This open-label, randomized controlled trial involves 130 term newborn infants (gestational ages between 37 weeks to 42 weeks) who need heel lancing for newborn screening. Subjects are randomly assigned to low level laser group or breast milk group. Subjects in breast milk group are given 5ml expressed breast milk by mouth using a syringe tube inserted to the participant's oral cavity over a 2-minute period. LaserPen is applied to the local point for 20 seconds where heel-lancing will be performed in the low level laser group. Then heel lancing is performed and two observers who are blinded to the intervention record the physiological (heart rate and oxygen saturation) and behavioral parameters (duration of crying and modified neonatal facial coding scores) following the procedure. Heart rate variation of participants is record by CheckMyHeart ECG monitor. The salivary swab method is used to detect the infant's salivary cortisol and amylase level as biomarker for stress evaluation. During the study course, digital cameras continuously record participants' behavior. Independent t-test, chi-squared test and one way ANOVA are used for statistical analysis.

Conditions

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Procedural Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

low level laser group and breast milk group

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Two independent assessors blinded to intervention read the video, and then record vital signs and pain score. The videos are cut from heel-lancing to the end so that the assessors do not know whether the neonate receive low level laser or breast milk.

Study Groups

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low level laser group

LaserPen is applied to the local point for 20 seconds where heel-lancing will be performed in the low level laser group.

Group Type EXPERIMENTAL

LaserPen

Intervention Type DEVICE

low level laser is used before heel-lancing for newborn screening

breast milk group

Subjects in breast milk group are given 5ml expressed breast milk by mouth using a syringe tube inserted to the participant's oral cavity over a 2-minute period before heel-lancing.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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LaserPen

low level laser is used before heel-lancing for newborn screening

Intervention Type DEVICE

Other Intervention Names

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power 150mW, wavelength 810nm, RJ-laser

Eligibility Criteria

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Inclusion Criteria

* healthy fullterm neonates (37-42 gestational age)
* Apgar score \>= 7
* will receive newborn screening

Exclusion Criteria

* \>42 or \< 37 gestational age
* perinatal asphyxia
* major malformations or any other disease that need intensive care
* drug withdrawal received previous treatment

Minimum Eligible Age

2 Days

Maximum Eligible Age

4 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes