Effect of Nipple Shield Use on Exclusive Breastfeeding up to 6 Months in Mothers with Nipple Abnormalities: A Randomized Controlled Trial

Background and Objective: Exclusive breastfeeding (EBF) benefits infant health; however, nipple abnormalities or pain can hinder latch. Given uncertain long-term effects, we evaluated nipple shields’ impact on breastfeeding through 6 months postpartum. Methods: This randomized controlled trial was conducted at Siriraj Hospital, Bangkok, Thailand. Postpartum mothers with nipple abnormalities after late-preterm or term delivery were consecutively recruited and randomized 1:1 to nipple shield or control groups. Sample size was calculated assuming a two-sided α of 0.05, 80% power, and expected improvement in EBF from 20% to 50%, with 10% attrition, yielding 330 participants per group. Breastfeeding outcomes were assessed at 1, 2, 3, and 6 months using a structured questionnaire based on World Health Organization definitions. Demographics were compared using chi-square and independent t tests; EBF over time was analyzed using chi-square and Cochran’s Q tests. Variables with P < 0.10 in univariable tests entered multivariable regression, with associations expressed as relative risks and 95% CIs. Results: At baseline, short nipples were more frequent with shields, whereas cracked nipples were more frequent in controls. At 2 months, EBF was higher with shields (47.8% vs 37.3%, P = 0.016), and the difference persisted at 3 months (40.0% vs 31.6%, P = 0.008). By 6 months, EBF declined in both groups (25.5% vs 22.1%, P = 0.361). Among mothers with short nipples, shields conferred benefit (26.9% vs 17.9%, P = 0.027). When breastfeeding continuation was defined as exclusive or partial breastfeeding, crude continuation rates at 6 months were lower in the nipple shield group than in controls (53.0% vs 63.6%, P = 0.007). While nipple shields improved exclusive breastfeeding at 2 and 3 months, this benefit did not persist at 6 months. Limitations include reliance on maternal report and lack of post-discharge infant growth data. Conclusion: Nipple shield use improved exclusive breastfeeding during the early postpartum period, particularly at 2 and 3 months, with the clearest benefit among mothers with short nipples. However, this advantage did not persist to 6 months, and crude rates of overall breastfeeding continuation at 6 months were lower among mothers who used nipple shields. Nipple shields may be considered a temporary, targeted aid for selected anatomical barriers when integrated with structured lactation counseling and follow-up. Plain Language Summary: Breastfeeding is important for infant and maternal health, but some mothers experience nipple problems that make breastfeeding difficult. A nipple shield is a thin silicone device that may help babies latch more easily. However, its effects on longer-term breastfeeding are not well understood. This study examined whether using a nipple shield influences breastfeeding outcomes during the first 6 months after birth. We conducted a randomized controlled trial involving 660 mothers with nipple abnormalities after delivering late-preterm or term infants. Mothers were randomly assigned to either use a nipple shield or receive standard breastfeeding care. Breastfeeding status was assessed at 1, 2, 3, and 6 months after delivery. Mothers who used nipple shields were more likely to exclusively breastfeed at 2 and 3 months compared with those who did not use shields. By 6 months, exclusive breastfeeding rates had decreased in both groups and were similar. Among mothers with short nipples, nipple shield use showed greater benefit. However, when considering both exclusive and partial breastfeeding, fewer mothers in the nipple shield group were still breastfeeding at 6 months. These findings suggest that nipple shields may help support exclusive breastfeeding in the early postpartum period for selected mothers, particularly those with short nipples. However, this benefit did not continue to 6 months, and overall breastfeeding continuation was not higher. Nipple shields may be considered a short-term aid when combined with appropriate breastfeeding support and follow-up. Keywords: breastfeeding continuation, exclusive breastfeeding, maternal support, nipple abnormalities, nipple shield