Ethics statement:
This retrospective analytical and clinical nursing protocol was conducted using anonymized neonatal clinical records collected in accordance with institutional ethical standards and applicable clinical regulations. Patient-identifiable information was removed prior to analysis. The requirement for formal ethics committee approval and informed consent was waived because the study involved retrospective analysis of fully de-identified data collected during routine clinical care and did not involve direct patient contact or intervention.
This protocol describes the standardized clinical implementation and retrospective evaluation of routine nursing and phototherapy care for neonates with damp-heat type neonatal jaundice.
Patient selection
A total of 120 neonates meeting the predefined inclusion and exclusion criteria were retrospectively included in the study. The sample size was determined based on the total number of eligible anonymized neonatal cases available within the institutional study period from 2022 to 2023. The inclusion criteria were as follows: meeting the diagnostic criteria of pathological jaundice in modern medicine and the diagnostic criteria of damp-heat type jaundice in TCM; full-term neonates gestational age ≥ 37 weeks; age ≤ 28 days; birth weight > 2500 g; received phototherapy per institutional protocol; and clinical records containing complete treatment and outcome data that were anonymized before analysis.
The exclusion criteria included records with incomplete clinical data; neonatal jaundice combined with ABO or Rh hemolysis, obstructive jaundice, sepsis, genetic metabolic diseases such as G-6-PD deficiency, or mother-to-child transmission of viral hepatitis or skin ulceration or infection, heart failure, central nervous system injury, or concurrent serious systemic illness.
Routine care modalities
Based on the retrospective analysis of hospital records, two primary care approaches were identified among neonates diagnosed with damp-heat type neonatal jaundice. Both approaches were routinely implemented as part of standard nursing practice during the study period and were documented in the patients' medical records.
Clear water bath
Clear water bathing was administered once daily as part of general hygiene and comfort measures. The bath was typically administered in the morning, at least 1 h after feeding. Warm sterile water maintained at 37–39 °C was used in a sterile newborn bathtub, and a waterproof umbilical dressing was applied during the procedure. Bathing duration was approximately 10 min, and close attention was given to head and neck support, skin condition, body temperature, and signs of discomfort. Following bathing, neonates were dried with sterile gauze, kept warm, and returned to bassinets for continued observation.
Integrated TCM nursing interventions
The second intervention group received integrated TCM-based nursing interventions routinely applied within institutional neonatal care practices. Consistency of intervention implementation was retrospectively verified using standardized nursing records, daily treatment documentation, procedural checklists, and institutional neonatal care logs documenting administration of herbal bathing, acupoint massage, touch therapy, and phototherapy during hospitalization.
Herbal Bathing
A standardized herbal decoction containing Artemisia capillaris, Gardenia jasminoides, Scutellaria baicalensis, and Honeysuckle was prepared using approximately 10–15 g of each herb in 1000 mL of sterile water. The herbs were soaked for 20 min, boiled for 30 min, simmered for an additional 20 min, and filtered using sterile gauze before dilution with warm water to a final bathing volume of approximately 5 L. Bath temperature was maintained at 37–39 °C, and treatment duration was approximately 10 min once daily. Neonates were continuously monitored for skin irritation, temperature instability, excessive crying, respiratory discomfort, and feeding intolerance. Treatment was discontinued if adverse reactions or clinical instability occurred.
Acupoint Massage
Neonates were positioned supine in a warm and quiet environment. Gentle massage was administered by trained nursing personnel at Zhongwan, Zusanli, Tianshu, and Ganshu acupoints using circular clockwise movements with light pressure appropriate for neonatal skin sensitivity. Each acupoint was stimulated for approximately 1–2 min, with total session duration maintained at 10–15 min once daily. Massage was interrupted if neonates developed excessive crying, skin redness, respiratory instability, feeding intolerance, or temperature fluctuation.
Touch Therapy
Touch therapy was administered once daily in a temperature-controlled environment using sequential gentle tactile stimulation of the upper limbs, chest, abdomen, back, and lower limbs. Slow rhythmic movements were performed for approximately 10–15 min while monitoring neonatal temperature, skin condition, respiratory status, feeding tolerance, and behavioral responses throughout the procedure.
Phototherapy administration
Phototherapy was administered to neonates using a phototherapy unit emitting blue light in the wavelength range of 425–475 nm. The neonates were positioned approximately 30–45 cm below the light source while wearing protective eye coverings. Phototherapy sessions were administered according to institutional schedules with interruption for feeding, hydration assessment, diaper changing, and clinical monitoring. Body temperature, hydration status, stool frequency, feeding tolerance, skin condition, and signs of dehydration were monitored regularly throughout treatment. Phototherapy was discontinued according to institutional stopping criteria, including satisfactory bilirubin reduction, clinical improvement, or development of adverse reactions.
Outcome measures
The following variables were extracted from anonymized patient records to assess the clinical course and outcomes of neonatal jaundice management: (1) general clinical characteristics: gestational age at birth, age at enrollment, weight before and after treatment, and number of bowel movements per day. (2) symptoms and adverse reactions: degree of jaundice, treatment-related adverse reactions such as rash, peeling, and skin irritation. (3) serum total bilirubin (TBIL), indirect bilirubin (IBIL), alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transferase (γ-GT), lactate dehydrogenase (LDH), and C-reactive protein (CRP) before and after treatment. Bilirubin markers served as the principal laboratory indicators of neonatal jaundice response, whereas liver enzymes and inflammatory markers were evaluated as exploratory secondary laboratory outcomes associated with hepatic and systemic inflammatory status. Laboratory and clinical outcome measures were retrospectively evaluated using values recorded at admission (pre-treatment) and following completion of the institutional treatment course prior to discharge (post-treatment).
Transcutaneous bilirubin (TCB) measurements were obtained according to routine institutional neonatal monitoring procedures. Because phototherapy may influence TCB reliability due to transient skin bleaching effects, serum bilirubin markers including TBIL and IBIL were additionally evaluated as complementary laboratory outcome measures where available within the retrospective dataset. Post-treatment bilirubin measurements were retrospectively extracted following routine interruption or completion of phototherapy sessions according to standard institutional neonatal monitoring practices.
Efficacy evaluation criteria
Treatment outcomes were retrospectively categorized based on recorded post-treatment TCB values in accordance to the "Clinical Disease Diagnosis and Efficacy Determination Criteria" (2012) (2012 edition) issued by the State Administration of Traditional Chinese Medicine of China. These criteria are commonly used in Chinese clinical practice for standardized evaluation of therapeutic effectiveness in TCM-associated clinical conditions. Treatment response categories, including “effective,” “improved,” and “ineffective,” were retrospectively assigned according to documented post-treatment bilirubin reduction and clinical symptom improvement recorded in the patient charts. These categorical evaluations were primarily used for descriptive assessment of overall treatment response and safety outcomes. Because the present study was retrospective in design, outcome categorization was based on available institutional laboratory records and documented clinical response criteria rather than prospective age-adjusted bilirubin nomogram assessment. Postnatal age-specific bilirubin interpretation systems, including Bhutani nomogram-based risk stratification, were not consistently available within the retrospective dataset. The classifications used were: (1) Efficacy: after treatment, the sclera and systemic jaundice of children were significantly reduced, TCB <5 mg·dL-1 (85 µmol·L-1). (2) Effective: after treatment, the scleral and systemic jaundice of children partially subsided, TCB was 5–12.9 mg·dL-1 (85–221 µmol·L-1). (3) Invalid: after treatment, the scleral and systemic jaundice of the child did not fade significantly, TCB >12.9 mg·dL-1 (221 µmol·L-1).
Data analysis
The collected data were organized using Excel to establish a database, and statistical analysis was conducted using SPSS Statistics 19.0. To evaluate within-group treatment effects, biochemical markers were analyzed using paired t-tests. Baseline and between-group comparisons were performed using independent samples t-tests. Because the study utilized a retrospective observational design, regression analyses were primarily exploratory and were performed to evaluate potential associations between laboratory marker changes and documented treatment response patterns rather than to establish causal predictive relationships. Available baseline variables, including neonatal age, gestational age, birth weight, and baseline bilirubin measurements, were reviewed where consistently documented within institutional records. Cohen’s d values represented standardized within-group pre-treatment versus post-treatment changes rather than direct comparative treatment effects between groups. Effect sizes were calculated using Cohen’s d. A two-way mixed ANOVA was used to assess time, group, and interaction effects. Post hoc comparisons were conducted using Tukey HSD tests. Univariate and multivariate regression analyses were performed, and odds ratios with 95% confidence intervals were calculated. The statistical significance level was set at p < 0.05 (two-tailed).