The Effectiveness of Hyaluronic Acid for the Treatment of Damaged Nipples in Breastfeeding Women: a Double-blind Randomised, Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Healing of damaged nipples
研究概览
简要总结
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.
详细描述
A randomised, controlled, parallel, double-blinded clinical trial will be performed in the Breastfeeding Support Unit of the Health Centre 'Dom zdravlja' in Osijek-Baranja County, Croatia, in 2022.
A randomised controlled study design has been chosen for this trial to compare two ways of treating damaged nipples in breastfeeding women. Participants will be randomly divided into two groups. The randomisation procedure will ensure the reliability of the results. Participants are breastfeeding mothers, with damaged nipples, and their newborn babies. Eligible mothers will be directed to the Breastfeeding Support Unit by the Health Centre's Health Visitors during regular home visits. Participants will be included in the study only if both mother and child meet the inclusion criteria.
Participants will be divided into two groups by simple randomisation: a group receiving a hyaluronic acid preparation and a control group receiving a placebo preparation. Allocation will be performed using a computer-generated list of random numbers. The allocator will know which participant receives which preparation, whereas the main researcher and the participants will not know which preparation is used by any participants. All pregnancy and birth data will be collected from the medical documentation of the mother and the child.
The preparation containing hyaluronic acid and the neutral agent will be prepared in the Galenska laboratory, Ljekarna Srce, Osijek-Baranja County. The hyaluronic acid preparation will contain white vaseline and 0.2% sodium hyaluronate in a 30 g container. The preparation will be applied for five days, locally on the nipple skin area after every second breastfeeding session and at least four times in 24 hours, alternating it with breast milk. The hyaluronic acid preparation will be distributed in the same packaging as the neutral agent used by the control group. The control group participants will apply the neutral agent containing only white vaseline for five days after every second breastfeeding session and at least four times in 24 hours, alternating it with breast milk. All mothers will be advised to wash the nipple skin with water before the next breastfeed.
The participants will be examined four times during their first postpartum month in the Breastfeeding Support Unit of the Health Centre 'Dom zdravlja'. The first check-up will occur 72 to 120 hours postpartum when the participants will be introduced to the study, provide consent for participation in the study, and, according to the allocator's instructions, will receive the preparation to treat the damaged nipple skin. Then, the researcher will advise the participants on how to position their babies during breastfeeding and correct possible irregularities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Healing of damaged nipples
时间窗: 30 days
Nipple healing will be measured using the Nipple Trauma Score (NTS). Measurements will be performed by the lead researcher using the following scale: 0) no macroscopically visible skin changes; 1) erythema or edema or combination of both; 2) superficial damage with or without scab formation of less than 25% of the nipple surface; 3) superficial damage with or without scab formation of more than 25% of the nipple surface; 4) partial-thickness wound with or without scab formation of less than 25% of the nipple surface; 5) partial-thickness wound with or without scab formation of more than 25% of the nipple surface.
Level of nipple pain
时间窗: 30 days
Nipple pain will be estimated using an adapted VAS.The pain scale is marked by numbers 0 to 10, where 0 means no pain, and 10 is the highest pain imaginable. The mother will decide on the VAS scale, which measure best fits her pain: 0) no pain, feeling that the child is moving my breast; 1-2) minimal discomfort and pain; 3-5) moderate pain; 6-8) severe pain; 9-10) the severest pain I can imagine.
次要结局
- Mother's satisfaction with allocated treatment(30 days)
- Exclusive breastfeeding rates at days 3, 7, 10, and 30 postpartum.(30 days)
- Side effects in mother and child(30 days)