BACKGROUND
Feeding intolerance (FI), frequently resulting from gastrointestinal immaturity, is prevalent among premature infants. Current practices are gradually prioritizing nonpharmacological treatments, such as massage or “Tui na,” considering the potential side effects of prolonged medication use. Pediatric Tui na, a specialized massage therapy based on traditional Chinese medicine, has been widely studied for treating FI in premature infants. However, to our knowledge, no systematic review specifically focusing on the effectiveness and safety of traditional Chinese medicine–based pediatric Tui na for FI in premature infants has been published yet.
OBJECTIVE
This study aims to develop a protocol for a systematic review and meta-analysis for evaluating the safety and efficacy of pediatric Tui na for premature infants with FI.
METHODS
We will perform a comprehensive search in the following databases: Springer, Cochrane Library, Embase, MEDLINE, Clarivate Analytics, Physiotherapy Evidence Database (PEDro), CINAHL, PubMed, Scopus, World Health Organization (WHO) International Clinical Trials Registry Platform, and Chinese biomedical databases (Wanfang database, the China National Knowledge Infrastructure, Chinese Scientific Journals Database, and Chinese Biomedical Literature Databases), limited to studies published in Chinese and English languages between January 2000 and January 2023. The search strategy will use MeSH (Medical Subject Headings) terms and database-specific keywords. A total of 2 independent reviewers will initially screen the studies based on titles and abstracts, followed by a full-text evaluation of the eligible studies. Studies will include any nonrandomized controlled trials, nonrandomized clinical studies, randomized controlled trials, and quasi-experimental studies wherein the treatment group involves premature infants with FI given pediatric Tui na. Primary outcomes will be necrotizing enterocolitis, gastric residual volume, emesis, and stool blood. Secondary outcomes will be abdominal distension weight gain, time to achieve full enteral feeding, any adverse effects associated with pediatric Tui na, and length of hospital stay. The Cochrane Collaboration Risk of Bias Tool will be used to assess the risk of bias and methodological quality. Funnel plots will be used for evaluating publication bias. Meta-analysis will be conducted using the Review Manager software (version 5.4; Cochrane Collaboration). Subgroup analyses will be considered according to treatment received, country or setting, sex, and birth weight of premature infants (if heterogeneity is high, <i>I</i><sup>2</sup>≥50%).
RESULTS
This is a systematic review and meta-analysis protocol, so the results are not yet available. The protocol has been registered with PROSPERO (CRD42023390021). We are currently in the study selection phase. Results are expected to be completed by the end of 2023.
CONCLUSIONS
Following this protocol, a comprehensive and rigorous literature synthesis will be developed to assess the impact of pediatric Tui na treatment on premature infants with FI, enabling the determination of its efficacy and safety.
CLINICALTRIAL
PROSPERO CRD42023390021; https://tinyurl.com/bdf4kn23
INTERNATIONAL REGISTERED REPORT
PRR1-10.2196/46375