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Recruiting Phase 4 NCT05591651

Hyaluronic Acid for the Treatment of Damaged Nipples in Breastfeeding Women

Trial Parameters

Condition Cracked Nipple
Sponsor Specijalisticka Pedijatrijska Ordinacija prim.mr.sc. Maja Stimac, Specijalist Pedijatrije Sspecijalnosti Neonatologije
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 160
Sex FEMALE
Min Age N/A
Max Age N/A
Start Date 2023-01-09
Completion 2025-12
Interventions
Treatment of damaged nipple skin: Preparation with hyaluronic acidTreatment of damaged nipple skin: Neutral preparation without hyaluronic acid

Brief 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 Criteria

Inclusion Criteria: * 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 Criteria: * 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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