Status:
COMPLETED
Contribution of Acupuncture on Pain Related to the Screening of Premature Retinopathy (ROP) by Digital Camera
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Laser Stimulation
Eligibility:
All Genders
23-31 years
Phase:
NA
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 e...
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...
Eligibility Criteria
Inclusion
- 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
- Analgesic or sedative drug treatment (benzodiazepines, morphine and related) within 48 hours of the examination.
- Known chromosomal abnormality
Key Trial Info
Start Date :
March 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2020
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03757871
Start Date
March 26 2019
End Date
March 1 2020
Last Update
April 29 2020
Active Locations (1)
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1
Hôpital Robert Debré
Paris, France, 75019