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Trial record 49 of 3395 for:    Recruiting, Not yet recruiting, Available Studies | Pain

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

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ClinicalTrials.gov Identifier: NCT03268148
Recruitment Status : Recruiting
First Posted : August 31, 2017
Last Update Posted : September 6, 2017
Sponsor:
Information provided by (Responsible Party):
Bei-yu Wu, Chang Gung Memorial Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Procedural Pain Device: LaserPen Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: low level laser group and breast milk group
Masking: Single (Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Prevention
Official Title: Analgesic Effect of Low Level Laser for Procedural Pain in Newborn Infants: an Open-label, Randomized-controlled Trial
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : July 31, 2018
Estimated Study Completion Date : July 31, 2019

Arm Intervention/treatment
Experimental: 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.
Device: LaserPen
low level laser is used before heel-lancing for newborn screening
Other Name: power 150mW, wavelength 810nm, RJ-laser

No Intervention: 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.



Primary Outcome Measures :
  1. pain assessment [ Time Frame: immediately after heel-lancing ]
    latency of first cry, crying time, squeezing time, neonatal facial coding system(NFCS), Neonatal Pain, Agitation and Sedation Scale (NPASS)


Secondary Outcome Measures :
  1. stress biomarker [ Time Frame: baseline, immediately after heel-lancing, 20 minutes after heel-lancing ]
    The salivary swab method is used to detect the infant's salivary cortisol and amylase level at 3 time point.



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Ages Eligible for Study:   up to 4 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03268148


Contacts
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Contact: Bei-yu Wu, doctor +886-7-7317123 ext 2334 y7802@cgmh.org.tw
Contact: Mei-Chen Ou-Yang, doctor +886-7-7317123 ext 8715 oymj@cgmh.org.tw

Locations
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Taiwan
Kaohsiung Chang Gung Memorial Hospital Recruiting
Kaohsiung, Taiwan, 833
Contact: Bei-yu Wu, doctor    +886-7-7317123 ext 2334    y7802@cgmh.org.tw   
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
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Principal Investigator: Bei-yu Wu, doctor Chang Gung Memorial Hospital

Publications of Results:
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Responsible Party: Bei-yu Wu, Atteding doctor, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT03268148     History of Changes
Other Study ID Numbers: 201700474A3C501
First Posted: August 31, 2017    Key Record Dates
Last Update Posted: September 6, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Bei-yu Wu, Chang Gung Memorial Hospital:
neonates
pain
low level laser

Additional relevant MeSH terms:
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Pain, Procedural
Pain
Neurologic Manifestations
Signs and Symptoms
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs