This was a single-center, randomized controlled trial conducted from May 2021 to May 2023. Primary endpoints were nutritional status [albumin (ALB), total protein (TP) levels] and complication rates; secondary endpoints included Acute Physiology and Chronic Health Evaluation (APACHE) II/ Self-rating Anxiety Scale (SAS) scores and hospitalization duration. Sample size was calculated based on a 20% difference in ALB improvement (α = 0.05, β = 0.8), requiring 49 patients per group. Randomization was performed using block randomization (block size = 4) by an independent statistician. Due to the nature of the nursing interventions, blinding of patients and nursing staff was not feasible. However, to minimize assessment bias, the data analysts and statisticians were blinded to the group allocation throughout the data processing and analysis phase.

A total of 98 NICU patients with dysphagia were recruited in this study from May 2021 to May 2023 at Changzheng Hospital, the Second Affiliated Hospital of Naval Medical University. Inclusion criteria: (1) Admission to NICU after neurosurgery; (2) Existence of different degrees of dysphagia. Exclusion criteria: (1) patients who had suffered from aspiration or aspiration pneumonia before enrolment; (2) patients with dysphagia caused by primary laryngeal diseases before enrolment; (3) patients with contraindications to enteral gastrointestinal nutrition; (4) patients with difficulties in or contraindications to the retention or placement of gastrointestinal tubes; and (5) lack of clinical information. Dysphagia was assessed using SSA. This study was conducted in accordance with the Declaration of Helsinki and approved by the Ethics Committee of Changzheng Hospital, the Second Affiliated Hospital of Naval Medical University (Approval No. 2024SL01162, Date: April 2024). The trial was retrospectively registered at Chinese Clinical Trial Registry (ChiCTR2500099576).

The control group (CG) of NICU patients with dysphagia was provided with routine nursing care with nasogastric tube feeding with standard enteral formula (1.5 kcal/mL), including postoperative vital signs monitoring, medication administration as prescribed by the doctor, reasonable dietary care, and rehabilitation and exercise guidance.

The treatment group (TG) adds fine-tuned nursing care on the basis of routine nursing, and the nursing measures are as follows:

Swallowing rehabilitation training: joint application of tongue movement training, training to enhance the ability of swallowing reflexes, pharyngeal movement training, ice stimulation and other methods of rehabilitation training for the oral cavity, face, pharynx and other methods (19). (1)

Oral rehabilitation training: instruct the patients to carry out motor rehabilitation training of the oral cavity, correctly instruct the patients to make “en”, “wu,” “yi”, “wu” in sequence sounds, each vocalization was maintained for 5s, repeated 10 times, and the next sound was trained after relaxation.

To ensure the standardized, consistent, and high-fidelity implementation of the nursing interventions across all patients and throughout the study duration, the following measures were rigorously implemented:

Development of a standardized protocol: A detailed, step-by-step nursing intervention manual was developed prior to the study commencement. This manual explicitly outlined all components of the fine-tuned nursing care for the TG, including the specific procedures, frequency, duration, and progression criteria for each swallowing rehabilitation exercise, airway care step, nutritional monitoring parameter, limb rehabilitation activity, and family education point. The routine care protocol for the CG was similarly standardized to avoid contamination.

Comprehensive training and assessment: All nursing staff involved in the study (n = 15) underwent a centralized training program conducted by the principal investigator (a senior NICU head nurse) and a rehabilitation specialist. The training covered both the theoretical rationale and practical demonstration of all interventions. Competency was assessed through a written test and a practical skills evaluation. Only staff who passed both assessments were permitted to deliver the interventions.

Ongoing supervision and adherence monitoring: The principal investigator and a designated research nurse conducted weekly random audits and direct observations of the nursing care delivery for approximately 10% of the sessions in both groups. A pre-piloted checklist was used during these audits to document adherence to the standardized protocol. Any deviations were identified and discussed with the nursing staff immediately for corrective action. This process ensured that the interventions were delivered as intended throughout the study.

The observation indexes are shown as follows:

Hospitalization time: observe the ICU stay time and hospitalization time of the two groups and take the mean value.

SPSS 20.0 was used to process and analyze the data, and GraphPad Prism 8.0 was used to plot the graphs. Count data and measurement data were expressed as n (%) and mean ± SD, respectively, and differences were tested using the X² test and t-test. p < 0.05 was statistically significant. The primary analysis was based on the Per-Protocol (PP) population. A supportive Intention-to-Treat (ITT) analysis using the Last Observation Carried Forward (LOCF) method was also performed for the primary outcomes to assess the robustness of the results.

Of the 112 patients assessed for eligibility between May 2021 and May 2023, 14 were excluded (8 declined to participate, 6 did not meet inclusion criteria). The remaining 98 patients were successfully randomized into the Control Group (CG, n = 49) and the Treatment Group (TG, n = 49). The flow of participants through the study is detailed in Figure 1 (Consort Diagram).

Following randomization, three patients in each group were lost to follow-up before the primary endpoint assessment (Day 7). In the CG, two patients were transferred to another hospital for family reasons, and one patient's family requested early discharge due to financial constraints. In the TG, two patients' families requested early discharge, and one patient was transferred following a sudden, unrelated cardiovascular event. Consequently, the Per-Protocol (PP) population, which completed the entire study protocol and had complete data for the primary outcomes, consisted of 46 patients in each group.

To assess the potential impact of these post-randomization dropouts on our results, we performed both Per-Protocol (PP) and Intention-to-Treat (ITT) analyses for the primary endpoints (Albumin level and complication rate). For the ITT analysis, the Last Observation Carried Forward (LOCF) method was used to impute missing data for the 6 dropouts. The results of the ITT analysis were consistent in direction and statistical significance with the PP analysis presented in this manuscript, confirming the robustness of our primary findings.

Baseline characteristics of the PP population are summarized in Table 1. There were no statistically significant differences between the two groups in terms of age, gender, primary diagnosis, APACHE II score, or SSA score at admission (all P > 0.05), indicating that the randomized groups were well-balanced and that the dropouts did not introduce apparent selection bias.

ICU admission time and hospitalization time were notably lower in the TG than in the CG (P < 0.05). See Figure 2.

There was no highlight between the ALB and TP levels of the two groups of patients at the time of admission (P > 0.05), and the ALB and TP levels of the two groups were monitored again on the seventh day of care, and it was found that the ALB and TP levels of the TG were notably higher than those of the CG (mean difference: 4.2 g/L, 95% CI: 2.1–6.3 g/L, P < 0.05) and the TP level was also significantly elevated (mean difference: 5.1 g/L, 95% CI: 2.8–7.4 g/L, P < 0.05). As shown in Figure 3.

At the time of admission, the SAS scores of patients in both groups were high, and there was no statistical difference (P > 0.05). The scores decreased in both groups after seven days of care and the SAS scores of patients in the TG were notably lower than those in the CG (P < 0.05). See Figure 4.

The APACHE II scores of patients in both groups were higher at the time of admission, and there was no statistical difference (P > 0.05), and the scores of both groups decreased after seven days of care and the APACHE II scores of patients in the TG were notably lower than those in the CG (P < 0.05). See Figure 5.

Complications such as aspiration, aspiration pneumonia, sepsis and pressure sores mainly occur in the process of therapeutic care in the two groups. The complication rate of TG is notably lower than that of the CG (P < 0.05). See Table 2.

At the time of admission, no significant differences were observed in serum CRP and PCT levels between the two groups (P > 0.05), indicating comparable baseline inflammatory status. After seven days of care, inflammatory markers decreased in both groups. However, the reductions were significantly more pronounced in the TG compared to the CG. The TG demonstrated notably lower CRP levels (mean difference: −6.3 mg/L, 95% CI: −8.1 to −4.5 mg/L, P < 0.05) and PCT levels (mean difference: −0.07 ng/mL, 95% CI: −0.10 to −0.04 ng/mL, P < 0.05) on day 7. See Figure 6. These objective laboratory findings corroborate the clinical observation of a lower incidence of aspiration pneumonia in the TG, suggesting that the combined intervention more effectively controlled systemic inflammation.

The nursing satisfaction scores in the TG were notably higher than those in the CG (p < 0.05). See Table 3.

No tube feeding-related adverse events (e.g., diarrhea, tube displacement) or significant vital sign abnormalities were reported. Laboratory values (e.g., electrolytes, liver function) remained within normal ranges in both groups.