Contribution of Acupuncture on Pain Related to the Screening of Premature Retinopathy (ROP) by Digital Camera (ELAROP)

Pain management in premature infants is essential because they are exposed to repeated minor painful procedures such as screening for premature retinopathy (ROP). Acupuncture has shown its analgesic effectiveness in many studies. Laser acupuncture is a simple, fast, side-effect-free method, but no study exists on the contribution of acupuncture in the management of pain caused by the examination of the fundus in addition to conventional therapies (suction, Glucose G30%, anaesthetic eye drops) which are not sufficiently effective.

Hypothesis: Laser acupuncture is a medical device that would reduce the pain and discomfort of premature newborns when examining the fundus with a digital camera.

Study Overview

• Status: Completed
• Conditions: Laser Stimulation
• Intervention / Treatment: Device: Laser stimulation

Detailed Description

Randomized, single-centre, randomized, double-blind, randomized, controlled clinical trial in two parallel groups, acupuncture versus placebo as an add-on to the usual analgesic strategy (Glucose G 30%/suction and administration of a drop of anesthetic eye drops). The main objective is to evaluate the contribution of acupuncture versus placebo as an add-on to the G30% glucose solution 2 minutes before the examination associated with the instillation of a drop of oxybuprocaine administered 1 minute before the start of the examination on pain assessed at the first eye fundus (FO) by the score premature infant pain profile (PIPP) measured before the start of the examination (baseline) and on 30 seconds after the examination of both eyes.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75019
    • Hôpital Robert Debré

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 months to 7 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Premature from 23+0 to 30sa+6d regardless of birth weight with 1st FO for ROP screening;
• Premature birth weights < 1250g with a 1st FO for ROP screening;
• Informed consent of the holder(s) of parental authority;
• Child benefiting from a social security system

Exclusion Criteria:

• Analgesic or sedative drug treatment (benzodiazepines, morphine and related) within 48 hours of the examination.
• Known chromosomal abnormality

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Laser Stimulation; laser pen acupuncture projecting an infrared beam with a wavelength of 905nm bilaterally for 30 seconds on each point.	Device: Laser stimulation; an acupuncture or placebo session will be performed 30 minutes before the fundus examination. This session will last 5 minutes.
Placebo Comparator: Placebo; The placebo group will have an application of the pen according to the same extinguished laser criteria.	Device: Laser stimulation; an acupuncture or placebo session will be performed 30 minutes before the fundus examination. This session will last 5 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
score at PIPP (premature infant pain profile) ≥ 10	Measurement of pain or discomfort defined by a PIPP score ≥ 10	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain and discomfort	Assess pain and discomfort (score FANS). The FANS score is a validated hetero-rating scale for assessing acute newborn pain when the face is difficult to analyse. On the 0 to 10 side, the absence of pain is defined by a score < 3	24 hours
heart rate variability	assessment of heart rate variability (NIPE score)	24 hours

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Farnoux Caroline, PHD, APHP; Study Chair: Biran Valerie, PHD, APHP

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2019
• Primary Completion (Actual): March 1, 2020
• Study Completion (Actual): March 1, 2020

Study Registration Dates

• First Submitted: November 13, 2018
• First Submitted That Met QC Criteria: November 28, 2018
• First Posted (Actual): November 29, 2018

Study Record Updates

• Last Update Posted (Actual): April 29, 2020
• Last Update Submitted That Met QC Criteria: April 28, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Infant, Newborn, Diseases; Retinal Diseases; Infant, Premature, Diseases; Retinopathy of Prematurity
• Other Study ID Numbers: P171005J

Drug and device information, study documents

• 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