RecruitingPhase 4NCT05591651

Hyaluronic Acid for the Treatment of Damaged Nipples in Breastfeeding Women

The Effectiveness of Hyaluronic Acid for the Treatment of Damaged Nipples in Breastfeeding Women: a Double-blind Randomised, Controlled Trial

Sponsor

Specijalisticka Pedijatrijska Ordinacija prim.mr.sc. Maja Stimac, Specijalist Pedijatrije Sspecijalnosti Neonatologije

Enrollment

160 participants

Start Date

Jan 9, 2023

Study Type

INTERVENTIONAL

Conditions

Breastfeeding Cracked Nipple Healing Wound

Summary

Previous studies have shown that application of hyaluronic acid preparations to wounds of the skin and mucosa have a beneficial effect. There is a lack of studies showing the effect of applying hyaluronic acid preparations to treat damaged nipple skin in breastfeeding mothers. This study aims to determine the effect of applying a hyaluronic acid preparation to damaged nipple skin in breastfeeding women.

Eligibility

Sex: FEMALE

Inclusion Criteria2

for mothers: a breastfeeding mother, living or residing in Osijek, with nipple skin damage (NTS 1, 2, 3, 4, or 5).
for babies: newborns from a singleton pregnancy, of gestational age from 37 to 42 weeks, with a birth weight of 2,500 to 4,500 grams.

Exclusion Criteria2

for mothers: mothers who do not breastfeed, mothers not living or residing in Osijek, mothers without nipple skin damage and mothers using other preparations for healing sore nipples (shells, pads).
for children: visible anomalies in the newborn which may affect the breastfeeding process, newborns that required admission to the neonatal unit

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Interventions

DRUGTreatment of damaged nipple skin: Preparation with hyaluronic acid

The active preparation will be applied for five days, locally on the damaged nipple skin after every second breastfeeding session, and at least four times in 24 hours, alternating it with breast milk.

DRUGTreatment of damaged nipple skin: Neutral preparation without hyaluronic acid

The neutral preparation, containing only white vaseline, will be applied for five days, locally on the damaged nipple skin after every second breastfeeding session, and at least four times in 24 hours, alternating it with breast milk.