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

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ClinicalTrials.gov Identifier: NCT03757871
Recruitment Status : Not yet recruiting
First Posted : November 29, 2018
Last Update Posted : November 29, 2018
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Laser Stimulation Device: Laser stimulation Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Contribution of Acupuncture on Pain Related to the Screening of Premature Retinopathy (ROP) by Digital Camera
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. score at PIPP (premature infant pain profile) ≥ 10 [ Time Frame: 24 hours ]
    Measurement of pain or discomfort defined by a PIPP score ≥ 10


Secondary Outcome Measures :
  1. pain and discomfort [ Time Frame: 24 hours ]
    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

  2. heart rate variability [ Time Frame: 24 hours ]
    assessment of heart rate variability (NIPE score)



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Ages Eligible for Study:   23 Weeks to 31 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03757871


Contacts
Contact: Farnoux Caroline, PHD 01 40 03 20 60 caroline.farnoux@aphp.fr
Contact: Biran Valérie, PHD 01 40 03 41 91 valerie.biran@aphp.fr

Locations
France
Hôpital Robert Debré Not yet recruiting
Paris, France, 75019
Contact: Farnoux Carlone, PhD    01 40 03 20 61    caroline.farnoux@aphp.fr   
Contact: Biran Valerie, PHD    01 40 03 41 91    valerie.biran@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03757871     History of Changes
Other Study ID Numbers: P171005J
First Posted: November 29, 2018    Key Record Dates
Last Update Posted: November 29, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Retinopathy of Prematurity
Retinal Diseases
Eye Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases