Analgesic Effect of Low Level Laser for Procedural Pain in Newborn Infants
1 other identifier
interventional
123
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2017
CompletedFirst Submitted
Initial submission to the registry
August 29, 2017
CompletedFirst Posted
Study publicly available on registry
August 31, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedFebruary 27, 2020
February 1, 2020
1.9 years
August 29, 2017
February 26, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
stress biomarker
baseline, immediately after heel-lancing, 20 minutes after heel-lancing
Study Arms (2)
low level laser group
EXPERIMENTALLaserPen is applied to the local point for 20 seconds where heel-lancing will be performed in the low level laser group.
breast milk group
NO INTERVENTIONSubjects 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.
Interventions
low level laser is used before heel-lancing for newborn screening
Eligibility Criteria
You may qualify if:
- healthy fullterm neonates (37-42 gestational age)
- Apgar score \>= 7
- will receive newborn screening
You may not qualify if:
- \>42 or \< 37 gestational age
- perinatal asphyxia
- major malformations or any other disease that need intensive care
- drug withdrawal received previous treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 833, Taiwan
Related Publications (1)
Ou-Yang MC, Chen IL, Chen CC, Chung MY, Chen FS, Huang HC. Expressed breast milk for procedural pain in preterm neonates: a randomized, double-blind, placebo-controlled trial. Acta Paediatr. 2013 Jan;102(1):15-21. doi: 10.1111/apa.12045. Epub 2012 Nov 1.
PMID: 23057434RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bei-yu Wu, doctor
Chang Gung Memorial Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Atteding doctor
Study Record Dates
First Submitted
August 29, 2017
First Posted
August 31, 2017
Study Start
August 1, 2017
Primary Completion
June 30, 2019
Study Completion
December 31, 2019
Last Updated
February 27, 2020
Record last verified: 2020-02