Nipple Disorder Clinical Trial
— ELTTNFOfficial title:
Effect of LED Therapy for the Treatment Nipple Fissures: a Randomized Controlled Trial
Verified date | April 2018 |
Source | University of Nove de Julho |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Treatment options for nipple fissures include drug therapy with antifungal and antibiotics, topical applications of lanolin, glycerin gel, creams and lotions, the milk itself, hot compresses and silicone nipple shields. Studies involving a light-emitting diode (LED) therapy have demonstrated anti-inflammatory properties, the enhancement of the wound repair process and the control of pain.
Status | Not yet recruiting |
Enrollment | 100 |
Est. completion date | August 20, 2019 |
Est. primary completion date | September 20, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Nursing mothers aged 18 years or older 2. Diagnosis of nipple fissure and nipple pain with a minimum score of 1 on the Store and Champion scales 3. Having given birth to a healthy, full-term child 4. Performing exclusive breastfeeding 5. Newborn with no oral, palatal or maxillofacial abnormalities 6. Newborn weighing between 2500 and 4000 grams Exclusion Criteria: 1. History of psychological disorder 2. Presence of mastitis 3. Bacterial or fungal infection in breasts 4. Use of breast pump or plastic nipple |
Country | Name | City | State |
---|---|---|---|
Brazil | Mandaqui Hospital | São Paulo | Sao Paulo |
Lead Sponsor | Collaborator |
---|---|
University of Nove de Julho |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Nipple fissure | Nipple fissure will be evaluate with digital calipers - Black Bull Scale | 1 week |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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