ELTTNF: Effect of LED Therapy for Treatment Nipple Fissure

• Sponsor: University of Nove de Julho (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03496753
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 8.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Nipple Disorder	Device: Led Therapy	N/A

Detailed 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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized clinical trialRandomized clinical trial
• Masking: Single (Outcomes Assessor)
• Masking Description: Statistic analysis
• Primary Purpose: Treatment
• Official Title: Effect of LED Therapy for the Treatment Nipple Fissures: a Randomized Controlled Trial
• Anticipated Study Start Date: Aug 20, 2018
• Anticipated Primary Completion Date: Sep 20, 2018
• Anticipated Study Completion Date: Aug 20, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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.
No Intervention: Control The control group will receive orientation regarding breast care and adequate breastfeeding techniques. The experimental group will receive the same orientation plus phototherapy sessions using a device developed especially for the treatment of nipple trauma. Both groups will be followed up for six consecutive weeks.

Outcome Measures

Primary Outcome Measures

1. Nipple fissure [1 week]

   Nipple fissure will be evaluate with digital calipers - Black Bull Scale

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mandaqui Hospital	São Paulo	Sao Paulo	Brazil	02401400

Sponsors and Collaborators

• University of Nove de Julho

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lara Jansiski Motta, Principal Investigator, University of Nove de Julho
• ClinicalTrials.gov Identifier: NCT03496753
• Other Study ID Numbers: LEDNipple01
• First Posted: Apr 12, 2018
• Last Update Posted: Apr 12, 2018
• Last Verified: Apr 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Lara Jansiski Motta, Principal Investigator, University of Nove de Julho: nipple fissure

Study Results

No Results Posted as of Apr 12, 2018