Effect of LED Therapy for Treatment Nipple Fissure

Nipple Disorder Clinical Trial

— ELTTNF  

Official title:

Effect of LED Therapy for the Treatment Nipple Fissures: a Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03496753
• Other study ID #: LEDNipple01
• Status: Not yet recruiting
• Phase: N/A
• First received: March 28, 2018
• Last updated: April 5, 2018
• Start date: August 20, 2018
• Est. completion date: August 20, 2019

Study information

• Verified date: April 2018
• Source: University of Nove de Julho
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Nipple fissures are the second major cause of the discontinuation of breastfeeding, following a sensation of insufficient milk, which leads to bottle feeding. Poor positioning of the child in relation to the breast, an inadequate frequency or duration of breastfeeding and improper suckling are the main causes of nipple fissure. Discontinuing breastfeeding deprives the infant of essential nutrients and also deprives the mother of certain health benefits. 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. As it does not cause discomfort, is relatively inexpensive and may impede the discontinuation of breastfeeding, phototherapy could be a viable option for the treatment of nipple fissures.

The aim of this study is to evaluate LED therapy in treatment of nipple fissures

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Nipple Disorder

Intervention

Device:
• Led Therapy
The following will be the phototherapeutic parameters: total spot area: 1.44 cm²; continuous emission mode; output power: 10 mW; infrared wavelength (880 to 904 nm); fluence: 4 J/cm²; and application time: 10 minutes/session. Sessions will be held three times a week on alternating days for six consecutive weeks, totaling 18 sessions.

Locations

Country	Name	City	State
Brazil	Mandaqui Hospital	São Paulo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Nove de Julho

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nipple fissure	Nipple fissure will be evaluate with digital calipers - Black Bull Scale	1 week