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

Abstract

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.