Feeding intolerance (FI) is usually a consequence of gastrointestinal immaturity and commonly occurs in premature infants [1]. It typically presents as increased gastric residual volume (GRV), abdominal distention, vomiting, stool blood, and emesis [2], affecting 33.8%-53.45% of premature infants in China [3]. Furthermore, there is an association between high GRV and increased morbidity of necrotizing enterocolitis (NEC) [4,5]. These gastrointestinal immaturity–associated intestinal system problems can affect the nutritional intake and gut morbidity of premature infants, leading to several complications such as prolonged hospitalization and weight loss, and even increased mortality [6,7], thus placing a heavy burden on health care services.

There is no ideal or effective treatment available for FI as its pathobiology remains to be fully understood and identified [8-10]. Previous guidelines and studies have primarily focused on pharmacotherapies for managing FI [11]. However, long-term use of medications such as erythromycin, probiotics, metoclopramide, and cisapride has been reported to be associated with many adverse effects (AEs), including neurological disorders and cardiovascular dysfunction [12-16], leading to a greater expenditure of time and money and posing a significant burden on patients [10]. Consequently, current guidelines and practices increasingly focus on nonpharmacological treatments such as massage or Tui na [4,17]. Pediatric Tui na, based on the principles of the meridian theory [18] of traditional Chinese medicine (TCM) [19], is widely used as a complementary and alternative medicine in East Asia [20-23]. It treats a range of pediatric diseases by applying various manipulations on the body surface, including pressing, kneading, circling, nipping, and pushing [24,25]. Studies have indicated that Tui na and other similar touch therapies can regulate hormones such as cortisol and dopamine and accelerate blood and lymphatic circulation, thereby improving the function of the gastrointestinal system [3,21,22,26-29]. Many studies [24,25,29-32], especially those conducted in China, have explored pediatric Tui na as a treatment for FI in premature infants. However, the results of these studies are inconsistent. For instance, several investigations [24,25,30] have indicated that pediatric Tui na provides significant benefits to premature infants with FI, including improved weight gain; reduced time to achieve full enteral feeding; reduction in GRV, emesis, and abdominal distention; and a notable reduction in the average length of hospital stay. However, Liu and Zhang [31] did not find any significant difference between the control group and the pediatric Tui na group in terms of weight gain or the time required to return to birth weight (P>.05). Additionally, a meta-analysis [33] suggested that massage benefits premature infants with FI. However, this analysis was limited to studies published in Persian and English. Furthermore, it primarily evaluated the effects of massage on GRV and did not specifically address the efficacy and safety of pediatric Tui na regarding intestinal function and other FI-associated factors in premature infants. Therefore, despite the research mentioned above, to our knowledge, no studies have specifically addressed the safety and efficacy of pediatric Tui na in premature infants with FI, highlighting a gap in understanding its role as a nonpharmacological treatment for these infants. Moreover, no published systematic review, meta-analysis, or review protocol focusing on TCM-based pediatric Tui na for premature infants with FI is yet available.

Considering the high heterogeneity of previous studies and their varying outcomes, as well as the absence of any comprehensive evidence on this subject, it is crucial to assess the effectiveness and safety of pediatric Tui na for premature infants with FI. We intend to conduct a systematic review and meta-analysis to enhance the current evidence base on the effectiveness of pediatric Tui na for FI in premature infants. To ensure the most comprehensive data collection, minimize publication bias, and summarize the currently available evidence, we will conduct electronic searches for studies published both in English and Chinese.

This is a systematic review and meta-analysis protocol, so the results are not yet available. This protocol has been registered with PROSPERO (CRD42023390021) on February 8, 2023 [34]. We are currently in the study selection phase. Results are expected to be completed by the end of 2023.

This study aims to conduct a systematic review and meta-analysis of relevant research articles to comprehensively summarize the current evidence regarding the efficacy of pediatric Tui na for premature infants with FI. Pediatric Tui na, originated in China over 2300 years ago, was first recorded in Wushierbingfang (Prescriptions for Fifty-two Diseases) [42]. It is a commonly used, convenient, noninvasive, and cost-effective intervention therapy suitable for children [43]. Xie et al [44] reported that working on specific acupoints of the skin surface in pediatric Tui na can improve the gastrointestinal function of children. Xiao et al [24] and Chen [29] have reported that pediatric Tui na can accelerate gastrointestinal tract maturity, promote intestinal evacuation, and increase gastrointestinal motility in premature infants, thus alleviating FI. Although many clinical trials [24,25,30-32] have evaluated pediatric Tui na for treating FI in children, its efficacy and clinical evidence have not yet been established. The current clinical guidelines in China recommend massage therapy for treating FI in premature infants [17]. Despite being a TCM-based approach, pediatric Tui na is currently not included in the guidelines for treating FI in premature infants. This omission has prevented it from being widely and successfully adapted as a potential treatment for FI in premature infants. This study will be the first to evaluate the effect and safety of TCM-based pediatric Tui na for FI in premature infants by objectively synthesizing the currently available publications.

Some limitations should be considered in this systematic review. First, it will consider only studies published in Chinese and English, which could introduce potential language bias, resource constraints, difficulty locating non-English studies, and the possibility of bias in data extraction and analysis. Second, the specific focus of our research question might restrict the number of eligible studies for inclusion in the proposed review. Nonetheless, our objective is to extract valuable insights from the available evidence to offer preliminary guidance for current FI practices and future research. To stay updated with new evidence, we plan to conduct updates to the systematic review and meta-analysis every 3 years.

This protocol intends to aggregate current research, provide greater insights into the efficacy and safety of pediatric Tui na for FI, and offer a comprehensive assessment of the evidence for pediatric Tui na treatment of FI in premature infants for health care providers worldwide. Additionally, it will lay the groundwork for future research in pediatric Tui na and serve as a reference for the potential inclusion of pediatric Tui na in the treatment guidelines for premature infants with FI.