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

Study Overview
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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.

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.

Official Title
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Analgesic Effect of Low Level Laser for Procedural Pain in Newborn Infants: an Open-label, Randomized-controlled Trial

Conditions
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Procedural Pain

Intervention / Treatment
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* Device: LaserPen


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Days
Maximum Age: 4 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: low level laser group and breast milk group
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: low level laser group<br>LaserPen is applied to the local point for 20 seconds where heel-lancing will be performed in the low level laser group. | Device: LaserPen<br>* low level laser is used before heel-lancing for newborn screening<br>* Other names: power 150mW, wavelength 810nm, RJ-laser;|
| No Intervention: breast milk group<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain assessment | latency of first cry, crying time, squeezing time, neonatal facial coding system(NFCS), Neonatal Pain, Agitation and Sedation Scale (NPASS) | immediately after heel-lancing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stress biomarker | The salivary swab method is used to detect the infant's salivary cortisol and amylase level at 3 time point. | baseline, immediately after heel-lancing, 20 minutes after heel-lancing | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neonates, pain, low level laser