China ; Consensus ; Humans ; Infant, Newborn ; Infant, Premature ; Pulmonary Surfactants/therapeutic use* ; Respiratory Distress Syndrome, Newborn/drug therapy*

OBJECTIVE: To evaluate the efficacy and safety of less invasive surfactant administration (LISA) in the treatment of neonatal respiratory distress syndrome (NRDS). METHODS: PubMed, Cochrane Library, Embase, China Biology Medicine disc, China Scientific Journal Database, CNKI Database, and Wanfang Database were searched for randomized controlled trials (RCTs) on the use of LISA strategy in the treatment of NRDS. Literature screening and quality assessment were performed according to inclusion and exclusion criteria. Review Manager 5.3 software was used to perform the Meta analysis. RESULTS: A total of 9 RCTs were included, with a total of 1 212 children with NRDS. There were 611 children in the experimental group (treated with LISA strategy) and 601 children in the control group [treated with intubation-surfactant-extubation (INSURE) strategy]. The Meta analysis showed that the use of LISA strategy reduced the rate of mechanical ventilation within 72 hours after birth (OR=0.39, 95%CI: 0.29-0.51, P<0.001) and the incidence rates of bronchopulmonary dysplasia (OR=0.53, 95%CI: 0.38-0.72, P<0.001) and pneumothorax (OR=0.56, 95%CI: 0.33-0.93, P=0.02). There were no significant differences in the mortality rate and incidence rates of other neonatal diseases between the two groups (P>0.05). There was no significant difference in the rate of repeated use of pulmonary surfactant (PS) between the two groups (P>0.05), but there was a higher incidence rate of PS reflux observed by LISA strategy (OR=2.60, 95%CI: 1.64-4.12, P<0.001). CONCLUSIONS Compared with INSURE strategy, LISA strategy has advantages in reducing the need for mechanical ventilation and the incidence rates of bronchopulmonary dysplasia and pneumothorax in children with NRDS.
China ; Humans ; Infant, Newborn ; Infant, Premature ; Pulmonary Surfactants ; therapeutic use ; Respiratory Distress Syndrome, Newborn ; drug therapy ; Surface-Active Agents

OBJECTIVETo explore the clinical efficacy of intratracheal instillation of pulmonary surfactant (PS) combined with budesonide for preventing bronchopulmonary dysplasia (BPD) in very low birth weight (VLBW) infants.

METHODSThirty VLBW infants with gestational age <32 weeks who developed neonatal respiratory distress syndrome (NRDS) (grade III-IV) suffering from intrauterine infection were randomly assigned into a PS + budesonide group and a PS alone group. The changes were compared between the two groups in arterial blood gas indexes, oxygenation index (OI), duration of mechanical ventilation, duration of oxygen supplementation, incidence of BPD, mortality rate at 36 weeks corrected gestational age and incidences of other complications except BPD.

RESULTSCompared with the PS alone group, the PS+budesonide group had a lower incidence of BPD, shorter duration of mechanical ventilation and oxygen supplementation (P<0.05). On the 2nd to 6th day after treatment, the PS+budesonide group had higher pH value of arterial blood gas and OI and lower carbon dioxide partial pressure compared with the PS alone group (P<0.05). There were no significant differences in the mortality rate at 36 weeks corrected gestational age and the incidences of other complications except BPD between the two groups (P>0.05).

CONCLUSIONSIntratracheal instillation of PS combined with budesonide can effectively reduce the incidence of BPD in VLBW premature infants with severe NRDS.

Bronchopulmonary Dysplasia ; prevention & control ; Budesonide ; administration & dosage ; Female ; Humans ; Infant, Newborn ; Infant, Very Low Birth Weight ; Male ; Pulmonary Surfactants ; administration & dosage ; Respiration, Artificial ; Respiratory Distress Syndrome, Newborn ; drug therapy

To treat respiratory distress syndrome, surfactant is currently delivered via less invasive surfactant administration (LISA) or INtubation SURfactant Extubation (INSURE). The aim of this study was to compare the effect of the two delivery methods of surfactant on cerebral autoregulation. Near infrared spectroscopy monitoring was carried out to detect cerebral oxygen saturation (ScO), and the mean arterial blood pressure (MABP) was simultaneously recorded. Of 44 preterm infants included, the surfactant was administrated to 22 via LISA and 22 via INSURE. The clinical characteristics, treatments and outcomes of the infants showed no significant differences between the two groups. The correlation coefficient of ScOand MABP (r) 5 min before administration was similar in the two groups. During surfactant administration, rincreased in both groups (0.44±0.10 to 0.54±0.12 in LISA, 0.45±0.11 to 0.69±0.09 in INSURE). In the first and second 5 min after instillation, rwas not significantly different from baseline in the LISA group, but increased in the first 5 min after instillation (0.59±0.13, P=0.000 compared with the baseline in the same group) and recovered in the second 5 min after instillation (0.48±0.10, P=0.321) in the INSURE group. There were significant differences in the change rates of rbetween the two groups during and after surfactant administration. Our results suggest that cerebral autoregulation may be affected transiently by surfactant administration. The effect duration of LISA is shorter than that of INSURE (<5 min in LISA vs. 5-10 min in INSURE).
Administration, Intranasal ; adverse effects ; Brain ; metabolism ; Female ; Homeostasis ; Humans ; Infant, Newborn ; Infant, Premature ; Intubation ; adverse effects ; Male ; Oxygen Consumption ; Pulmonary Surfactants ; administration & dosage ; therapeutic use ; Respiratory Distress Syndrome, Newborn ; drug therapy ; therapy

PURPOSE: Pulmonary surfactant (PS) replacement has been the gold standard therapy for neonatal respiratory distress syndrome; however, almost all commercial PSs contain animal proteins. We prepared a synthetic PS by using a human surfactant protein (SP) analog and evaluated its in vitro properties. MATERIALS AND METHODS: A peptide sequence (CPVHLKRLLLLLLLLLLLLLLLL) of human SP-C was chosen to develop the peptide analog (SPa-C). The new synthetic SP-C PS (sSP-C PS) was synthesized from SPa-C, dipalmitoyl phosphatidylcholine, phosphatidyl glycerol, and palmitic acid. Physical properties of the sSP-C PS were evaluated by measuring the maximum and minimum surface tensions (STs), surfactant spreading, and adsorption rate. In addition, we recorded an ST-area diagram. The data obtained on sSP-C PS were subsequently compared with those of purified natural bovine surfactant (PNBS), and the commercial product, Surfacten(R). RESULTS: The sSP-C PS and Surfacten(R) were found to have maximum ST values of 32-33 mN/m, whereas that of PNBS was much lower at 19 mN/m. The minimum ST values of all three products were less than 10 mN/m. The values that were measured for the equilibrium ST of rapidly spreading sSP-C PS, Surfacten(R), and PNBS were 27, 27, and 24 mN/m, respectively. The surface adsorptions were found to be the same for all three PSs (20 mN/m). ST-area diagrams of sSP-C PS and Surfacten(R) revealed similar properties. CONCLUSION: In an in vitro experiment, the physical properties exhibited by sSP-C PS were similar to those of Surfacten(R). Further study is required to evaluate the in vivo efficacy.
1,2-Dipalmitoylphosphatidylcholine/analogs & derivatives ; Adsorption ; Amino Acid Sequence/*genetics ; Animals ; C-Peptide/*chemistry ; Cattle ; Humans ; Infant, Newborn ; Pulmonary Surfactant-Associated Protein C/*chemical synthesis/pharmacology ; Pulmonary Surfactants/*chemical synthesis/pharmacology ; Respiratory Distress Syndrome, Newborn/*drug therapy ; *Surface Properties ; *Surface Tension ; Surface-Active Agents

OBJECTIVETo study the efficacy of different preparations of budesonide combined with pulmonary surfactant (PS) in improving blood gas levels and preventing bronchopulmonary dysplasia (BPD) in preterm infants with neonatal respiratory distress syndrome (NRDS).

METHODSA total of 184 preterm infants who developed NRDS within 4 hours after birth were randomly administered with PS + continuous inhalation of budesonide aerosol (continuous aerosol group), PS+budesonide solution (solution group), PS + single inhalation of budesonide aerosol (single aerosol group), and PS alone, with 46 neonates in each group. The changes in arterial blood gas levels, rate of invasive mechanical ventilation after treatment, time of assisted ventilation, rate of repeated use of PS, and the incidence of BPD were compared between the four groups.

RESULTSOn the 2nd to 4th day after treatment, pH, PCO2, and oxygenation index (FiO2/PaO2) showed significant differences among the four groups, and the continuous aerosol group showed the most improvements of all indicators, followed by the solution group, single aerosol group, and PS alone group. The continuous aerosol group had a significantly shorter time of assisted ventilation than the other three groups (P<0.05). The solution group had a significantly shorter time of assisted ventilation than the single aerosol and PS alone groups (P<0.05). The rate of invasive mechanical ventilation after treatment, rate of repeated use of PS, and incidence of BPD showed significant differences among the four groups (P<0.05), and the continuous aerosol group had the lowest rates, followed by the solution group.

CONCLUSIONSA combination of PS and continuous inhalation of budesonide aerosol has a better efficacy in the treatment of NRDS than a combination of PS and budesonide solution. The difference in reducing the incidence of BDP between the two administration methods awaits further investigation with a larger sample size.

Bronchopulmonary Dysplasia ; prevention & control ; Budesonide ; administration & dosage ; Drug Therapy, Combination ; Female ; Humans ; Infant, Newborn ; Male ; Pulmonary Surfactants ; administration & dosage ; Respiration, Artificial ; Respiratory Distress Syndrome, Newborn ; drug therapy

PURPOSE: To compare the efficacy of the new drug calfactant with the commonly used drugs surfactant-TA and poractant alfa. MATERIALS AND METHODS: A total of 332 preterm infants at 24-31 weeks' gestation with respiratory distress syndrome (RDS) were enrolled and allocated to three groups according to the surfactant instilled; Group 1 (n=146, surfactant-TA), Group 2 (n=96, calfactant), and Group 3 (n=90, poractant alfa). The diagnosis of RDS and the decision to replace the pulmonary surfactant were left to the attending physician and based on patient severity determined by chest radiography and blood gas analysis. Data were collected and reviewed retrospectively using patient medical records. RESULTS: Demographic factors including gestational age, birth weight, Apgar score, clinical risk index for babies II score, and maternal status before delivery were not different between the study groups. Instances of surfactant redosing and pulmonary air leaks, as well as duration of mechanical ventilation, were also not different. Rates of patent ductus arteriosus, intraventricular hemorrhage (> or =grade III), periventricular leukomalacia, high stage retinopathy of prematurity, necrotizing enterocolitis (> or =stage II), and mortality were also similar, as was duration of hospital stay. Cases of pulmonary hemorrhage and moderate to severe bronchopulmonary dysplasia were increased in Group 3. CONCLUSION: Calfactant is equally as effective as surfactant-TA and poractant alfa. This was the first study comparing the efficacy of surfactant-TA, calfactant, and poractant alfa in a large number of preterm infants in Korea. Further randomized prospective studies on these surfactants are needed.
Biological Products/administration & dosage/*therapeutic use ; Birth Weight ; Bronchopulmonary Dysplasia/drug therapy ; Female ; Gestational Age ; Humans ; Infant, Newborn ; Infant, Premature ; Male ; Phospholipids/administration & dosage/*therapeutic use ; Pulmonary Surfactants/administration & dosage/*therapeutic use ; Republic of Korea ; Respiration, Artificial ; Respiratory Distress Syndrome, Newborn/*drug therapy ; Retrospective Studies ; Risk ; Treatment Outcome ; Ventilator Weaning

PURPOSE: To compare the efficacy of the new drug calfactant with the commonly used drugs surfactant-TA and poractant alfa. MATERIALS AND METHODS: A total of 332 preterm infants at 24-31 weeks' gestation with respiratory distress syndrome (RDS) were enrolled and allocated to three groups according to the surfactant instilled; Group 1 (n=146, surfactant-TA), Group 2 (n=96, calfactant), and Group 3 (n=90, poractant alfa). The diagnosis of RDS and the decision to replace the pulmonary surfactant were left to the attending physician and based on patient severity determined by chest radiography and blood gas analysis. Data were collected and reviewed retrospectively using patient medical records. RESULTS: Demographic factors including gestational age, birth weight, Apgar score, clinical risk index for babies II score, and maternal status before delivery were not different between the study groups. Instances of surfactant redosing and pulmonary air leaks, as well as duration of mechanical ventilation, were also not different. Rates of patent ductus arteriosus, intraventricular hemorrhage (> or =grade III), periventricular leukomalacia, high stage retinopathy of prematurity, necrotizing enterocolitis (> or =stage II), and mortality were also similar, as was duration of hospital stay. Cases of pulmonary hemorrhage and moderate to severe bronchopulmonary dysplasia were increased in Group 3. CONCLUSION: Calfactant is equally as effective as surfactant-TA and poractant alfa. This was the first study comparing the efficacy of surfactant-TA, calfactant, and poractant alfa in a large number of preterm infants in Korea. Further randomized prospective studies on these surfactants are needed.
Biological Products/administration & dosage/*therapeutic use ; Birth Weight ; Bronchopulmonary Dysplasia/drug therapy ; Female ; Gestational Age ; Humans ; Infant, Newborn ; Infant, Premature ; Male ; Phospholipids/administration & dosage/*therapeutic use ; Pulmonary Surfactants/administration & dosage/*therapeutic use ; Republic of Korea ; Respiration, Artificial ; Respiratory Distress Syndrome, Newborn/*drug therapy ; Retrospective Studies ; Risk ; Treatment Outcome ; Ventilator Weaning

OBJECTIVETo evaluate the efficacy of calf pulmonary surfactant (PS) in the treatment of respiratory distress syndrome (RDS) in late preterm and full-term infants.

METHODSA randomized controlled trial was designed to evaluate the efficacy of calf PS intratracheally given at different times and doses in infants with RDS who had a gestational age of ≥35 weeks and an oxygenation index (OI) of 10-20. The subjects were randomly assigned to treatment group 1 (n=58), treatment group 2 (n=58), and control group (n=59). Treatment group 1 was given PS (50 mg/kg) within 6 hours after admission. Treatment group 2 was given PS (70 mg/kg) within 6 hours after admission. The control group was not given PS within 6 hours after admission and was given PS (50 mg/kg) over 6 hours after admission if having no remission by conventional therapy including mechanical ventilation. For each group, a second dose of PS (50 mg/kg) was given if no remission was observed within 12 hours after the first administration.

RESULTSThere were no significant differences in mortality between the three groups. Treatment group 2 had lower hospitalization expense and shorter duration of mechanical ventilation compared with treatment group 1, and treatment group 1 had lower hospitalization expense and shorter duration of mechanical ventilation compared with the control group. The incidence of ventilator-associated pneumonia and length of hospital stay in treatment group 2 was lower than those in treatment group 1 and control group. Compared with the control group, Treatment groups 1 and 2 showed decreases in 2 or more times of PS use, maximum OI, duration of continuous positive airway pressure treatment, and incidence of air leak syndrome and pulmonary hypertension.

CONCLUSIONSEarly use of sufficient PS in late preterm and full-term infants with RDS can reduce complications, secondary use of PS, duration of mechanical ventilation and length of hospital stay, and hospitalization expense.

Female ; Hospitalization ; economics ; Humans ; Infant, Newborn ; Infant, Premature ; Male ; Pulmonary Surfactants ; therapeutic use ; Respiratory Distress Syndrome, Newborn ; drug therapy

OBJECTIVETo investigate the effect of pulmonary surfactant (PS) on the Th1/Th2 balance and serum levels of interleukin-4 (IL-4), interferon-γ (IFN-γ) and IgE in neonates with respiratory distress syndrome (RDS).

METHODSA total of 58 neonates with RDS were divided into control (n=20) and PS treatment groups (n=38). The control group underwent mechanical ventilation and other conventional treatment, while the PS treatment group received with bovine PS treatment within 1 hour of being admitted to the hospital together with mechanical ventilation and other conventional treatment. Enzyme-linked immunosorbent assay was used to measure serum levels of IL-4, IFN-γ and IgE before treatment and 24, 48 and 72 hours after treatment. Simultaneously, arterial blood gas, respiratory system compliance, and other ventilator parameters were recorded.

RESULTSCompared with the control group, the PS treatment group showed significantly shorter duration of mechanical ventilation and oxygen exposure time (P<0.05), significantly better respiratory system compliance and significantly lower oxygenation index 24, 48 and 72 hours after treatment (P<0.05). At 48 and 72 hours after treatment, serum levels of IFN-γ were significantly lower in the PS treatment group than in the control group (120±46 ng/L vs 229±59 ng/L, P<0.05; 141±40 ng/L vs 282±44 ng/L, P<0.05), and serum levels of IL-4 were significantly higher in the PS treatment group than in the control group (263±48 pg/mL vs 152±45 pg/mL, P<0.05; 417±49 pg/mL vs 201±46 pg/mL, P<0.05). At 72 hours after treatment, serum level of IgE was significantly lower in the PS treatment group than in the control group (115±44 pg/mL vs 199±43 ng/mL; P<0.05).

CONCLUSIONSPS treatment can shorten the duration of mechanical ventilation and oxygen exposure time, regulate serum levels of IFN-γ, IL-4 and IgE, and influence Th1/Th2 balance in neonates with RDS, thus inhibiting lung inflammatory response and reducing lung injury.

CD4 Lymphocyte Count ; Female ; Humans ; Immunoglobulin E ; blood ; Infant, Newborn ; Interferon-gamma ; blood ; Interleukin-4 ; blood ; Male ; Pulmonary Surfactants ; pharmacology ; therapeutic use ; Respiration, Artificial ; Respiratory Distress Syndrome, Newborn ; complications ; drug therapy ; immunology ; Th1 Cells ; immunology ; Th2 Cells ; immunology