Using hyaluronic acid to heal 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
This study tests if a hyaluronic acid treatment can help breastfeeding mothers heal damaged nipples better than a placebo.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Sex | Female |
| Sponsor | Specijalisticka Pedijatrijska Ordinacija prim.mr.sc. Maja Stimac, Specijalist Pedijatrije Sspecijalnosti Neonatologije Academic / other |
| Locations | 1 site (Osijek) |
| Trial ID | NCT05591651 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of a hyaluronic acid preparation in treating damaged nipple skin in breastfeeding mothers. It employs a randomized, controlled, parallel, double-blinded design, where participants are divided into two groups: one receiving the hyaluronic acid treatment and the other receiving a placebo. The study is conducted at the Breastfeeding Support Unit in Croatia, ensuring reliable results through randomization and blinding. Data on pregnancy and birth will be collected to assess the outcomes effectively.
Who should consider this trial
Good fit: Ideal candidates are breastfeeding mothers residing in Osijek with varying degrees of nipple skin damage.
Not a fit: Patients who do not breastfeed or have no nipple skin damage will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve healing for breastfeeding mothers experiencing nipple damage.
How similar studies have performed: Previous studies have shown positive effects of hyaluronic acid on skin and mucosal wounds, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Osijek
- Savjetovalište za dojenje, Dom zdravlja Osječko-baranjske županije — Osijek, Croatia (Recruiting)
Study contacts
- Principal investigator: Maja Štimac, MD; Mr.sc. — Specijalistička pedijatrijska ordinacija prim.mr.sc.Maja Štimac
- Study coordinator: Maja Štimac, MD; Mr.sc.
- Email: maja@stimac.org
- Phone: +385 98 799 188
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.