ABSTRACT
Objective:To investigate the efficacy and safety of nasal continuous positive airway pressure (NCPAP) combined with inhalation of pulmonary surfactant (PS) using vibrating mesh nebulizers in the treatment of neonatal respiratory distress syndrome (RDS).Methods:A prospective study was performed on premature infants with RDS admitted to the First Affiliated Hospital of Bengbu Medical College between December 2020 and June 2021. They were randomly assigned into vibrating mesh atomization technology group and intubation-surfactant-extubation (INSURE) technology group. The two groups were treated with NCPAP combined with PS. PS in the vibrating mesh atomization technology group was inhaled into the lungs by the new vibrating mesh atomization technology, while PS in the INSURE group was injected into the lungs by endotracheal tube. The pH value, arterial partial pressure of carbon dioxide (PaCO 2), oxygenation index (PaO 2/FiO 2), mechanical ventilation via endotracheal tube (MVET) demand rate, duration of respiratory support, secondary use of PS, complications, and hospital mortality were compared between the two groups. The occurrences of adverse events in the two groups were recorded. Results:A total of 42 preterm infants were finally enrolled, including 20 cases in the vibrating mesh atomization technology group and 22 cases in the INSURE technology group. There were no significant differences in blood gas analysis and PaO 2/FiO 2 before PS administration between the two groups. One hour after PS administration, blood gas analysis and PaO 2/FiO 2 were significantly improved in both groups. Compared with the INSURE technology group, the improvement of PaO 2/FiO 2 was more obvious in the vibrating mesh atomization technology group [mmHg (1 mmHg≈0.133 kPa): 198±34 vs. 173±39, P < 0.05], but no significant difference in pH value or PaCO 2 was found between the two groups. The duration of respiratory support in the vibrating mesh atomization technology group was significantly shorter than that in the INSURE technology group (hours: 96±13 vs. 120±18, P < 0.01), but there was no statistical difference in MVET demand rate [5.0% (1/20) vs. 13.6% (3/22), P > 0.05]. The incidence of periventricular-intraventricular hemorrhage (PVH-IVH) in the vibrating mesh atomization technology group was less than that in the INSURE technology group [0% (0/20) vs. 18.2% (4/22)], but no statistical difference was found ( P > 0.05). No significant differences in the secondary use rate of PS and incidence of bronchopulmonary dysplasia (BPD) or other complications were found between the vibrating mesh atomization technology group and the INSURE technology group [5.0% (1/20) vs. 9.1% (2/22), 5.0% (1/20) vs. 4.5% (1/22), both P > 0.05]. There were no deaths or serious adverse events such as pneumothorax, pulmonary hemorrhage, periventricular leukomalacia (PVL), retinopathy of prematurity (ROP), and necrotizing enterocolitis (NEC) in both groups. Conclusion:Compared with the INSURE technique, NCPAP combined with vibrating mesh atomization technology was also effective and safe in the treatment of RDS, which could significantly improve PaO 2/FiO 2 and shorten the duration of respiratory support. Thus, it was worthy of clinical popularization and application.
ABSTRACT
Objective To evaluate the efficacy and safety of selective brain hypothermia (SBH) in the treatment of neonates with moderate or severe neonatal hypoxic-ischemic encephalopathy (HIE), and the effect of SBH treatment on serum levels of neuron-specific enolase (NSE) and central nervous specific protein S100. Methods A prospective randomized controlled trial was conducted. From January 2015 to June 2017, 42 children with moderate to severe HIE in the neonatal intensive care unit (NICU) of the First Affiliated Hospital of Bengbu Medical College were enrolled, and they were randomly divided into SBH treatment group and routine treatment group after obtaining the consent of the guardian of the children. The children in routine treatment group were given the traditional symptomatic supportive treatment, supplemented by drugs to promote nerve cell growth. On the basis of traditional treatment, the children in the SBH treatment group were given SBH treatment within 6 hours after birth. The nasopharyngeal temperature was maintained at 33.0-34.5 ℃ and the rectal temperature was maintained at 34.5-35.0 ℃. The general clinical data of the two groups including gender, gestational age, birth weight, age, 5-minute neonatal asphyxia score (Apgar score), score for neonatal acute physiology perinatal extension version Ⅱ (SNAPPEⅡ) were collected. The primary outcomes were hospitalized death, severe disability at 15 months of age, neonatal behavioral neurological assessment (NBNA) score at 28 days of age, and Bayley scales of infant development (BSID) score [including mental development index (MDI) score and psychomotor development index (PDI) score] at 15 months of age at follow-up. The secondary outcomes were serum levels of NSE and S100 protein. The occurrences of adverse events in the two groups were recorded. Results Among 42 HIE children, 1 child of severe congenital malformation and 1 child of platelet count (PLT)﹤50×109/L were excluded, and 40 children were enrolled in the study group. During the follow-up period, 2 children of SBH treatment group and 2 children of routine treatment group were lost or the outcome was unknown. Finally, 18 children of each group were enrolled in the analysis. There was no significant difference in the baseline data of gender, gestational age, birth weight, age, 5-minure Apgar score or SNAPPEⅡ score between the two groups, indicating that the baseline data of the two groups were balanced and comparable. The incidence of severe disability in the SBH treatment group was significantly lower than that in the routine treatment group [5.6% (1/18) vs. 44.4% (8/18), P﹤0.05]. There was 1 child death in the routine treatment group and no death in the SBH treatment group. Compared with the routine treatment group, the 28-day NBNA score of the SBH treatment group was increased by 2.9 [95% confidence interval (95%CI) = 1.0-4.8], BSID score at 15 months of age was improved significantly, MDI score was increased by 11.8 (95%CI = 4.3-19.3), and PDI score was increased by 12.4 (95%CI = 2.5-22.3), with significant differences between the two groups (all P﹤0.05). After 3 days of treatment, the serum NSE and S100 protein levels in both groups were significantly decreased as compared with those before treatment [NSE (μg/L): 30.15±15.18 vs. 31.32±14.75, S100 (ng/L): 387.5 (273.3, 573.0) vs. 890.0 (590.5, 1 162.5) in routine treatment group; NSE (μg/L): 29.09±16.22 vs. 32.25±15.43, S100 (ng/L): 402.5 (302.2, 580.5) vs. 842.0 (462.3, 1 200.5) in SBH treatment group, all P﹤0.05]. There was no significant difference in serum NSE or S100 protein level between the two groups (all P﹥0.05). There was no serious adverse event such as arrhythmia, large vein thrombosis or irreducible hypotension in both groups, and there was no significant difference in the incidence of general adverse events such as sinus bradycardia, scleredema, blood glucose disorder, or systemic infection between the two groups [16.7% (3/18) vs. 11.1% (2/18), 5.6% (1/18) vs. 5.6% (1/18), 22.2% (4/18) vs. 11.1% (2/18), 5.6% (1/18) vs. 5.6% (1/18), all P﹥0.05]. Conclusions SBH treatment could significantly increase the NBNA score at 28 days of birth and BSID score at 15 months of age, reduce the incidence of severe disability in moderate and severe HIE children, but it was not be proved that SBH could reduce the mortality. Compared with routine treatment, SBH treatment had no significant superiority on improving the levels of serum NSE and S100 protein, suggesting that SBH could not protect the brain by inhibiting the apoptosis of nerve cells and promoting the repair of nerve cells.