OBJECTIVES: To study the efficacy and safety of early intratracheal administration of budesonide combined with pulmonary surfactant (PS) in preventing bronchopulmonary dysplasia (BPD). METHODS: A prospective randomized controlled trial was designed. A total of 122 infants with a high risk of BPD who were admitted to the neonatal intensive care unit of the Third Affiliated Hospital of Zhengzhou University from January to July 2021 were enrolled. The infants were randomly divided into a conventional treatment group with 62 infants (treated with PS alone at an initial dose of 200 mg/kg, followed by a dose of 100 mg/kg according to the condition of the infant) and an observation group with 60 infants (treated with PS at the same dose as the conventional treatment group, with the addition of budesonide 0.25 mg/kg for intratracheal instillation at each time of PS application). The two groups were compared in terms of the times of PS use, ventilator parameters at different time points, oxygen inhalation, incidence rate and severity of BPD, incidence rate of complications, and tidal breathing pulmonary function at the corrected gestational age of 40 weeks. RESULTS: Compared with the conventional treatment group, the observation group had a significantly lower proportion of infants using PS for two or three times (P<0.05). Compared with the conventional treatment group, the observation group had a significantly lower fraction of inspired oxygen at 24 and 48 hours and 3, 7, and 21 days after administration, significantly shorter durations of invasive ventilation, noninvasive ventilation, ventilator application, and oxygen therapy, a significantly lower incidence rate of BPD, and a significantly lower severity of BPD (P<0.05). There was no significant difference in the incidence rate of glucocorticoid-related complications between the two groups (P>0.05). CONCLUSIONS Compared with PS use alone in preterm infants with a high risk of BPD, budesonide combined with PS can reduce repeated use of PS, lower ventilator parameters, shorten the duration of respiratory support, and reduce the incidence rate and severity of BPD, without increasing the incidence rate of glucocorticoid-related complications.
Bronchopulmonary Dysplasia/prevention & control* ; Budesonide ; Humans ; Infant ; Infant, Newborn ; Infant, Premature ; Prospective Studies ; Pulmonary Surfactants/therapeutic use* ; Respiration, Artificial ; Respiratory Distress Syndrome, Newborn/therapy*

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

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

OBJECTIVETo investigate the clinical features, prevention and treatment of respiratory distress syndrome (RDS) in neonates of different gestational ages (GA) in the tertiary hospitals in Northwest China.

METHODSA total of 440 neonates diagnosed with RDS between January and December, 2011 in 12 tertiary hospitals in Northwest China were enrolled and classified into three groups: early preterm (GA<34 weeks; n=247), late preterm (GA 34-36(+6) weeks; n=131) and full-term (GA≥37 weeks; n=62). The clinical data, including perinatal factors, prevention and treatment, complications and prognosis, were comparatively analyzed among the three groups.

RESULTSThe rate of multiple births in the early preterm group was higher than the other two groups. The two preterm groups showed a higher incidence of premature rupture of membranes than the full-term group. The full-term group had a higher rate of cesarean section without contractions than the two preterm groups. The early preterm group had the highest application rate of antenatal steroids. Compared with the other two groups, the early preterm group had a higher application rate of pulmonary surfactants (PS) and an earlier time of first application of PS. The full-term group had a lower resuscitation rate than the two preterm groups. The early preterm group showed a higher incidence of patent ductus arteriosus and intracranial hemorrhage than the other two groups. The cure rate of RDS (78.2%) was the highest in the full-term group, followed by the late preterm group (58.6%) and the early preterm group (42.9%).

CONCLUSIONSRDS infants of different GA in Northwest China have significant differences in perinatal factors, antenatal prevention, PS treatment, complications and prognosis.

China ; Female ; Gestational Age ; Humans ; Infant, Newborn ; Infant, Premature ; Male ; Natriuretic Peptide, Brain ; blood ; Respiratory Distress Syndrome, Newborn ; blood ; prevention & control ; therapy ; Tertiary Care Centers

Pulmonary surfactant (PS) therapy was proven to be highly successful for the treatment of respiratory distress syndrome in premature infants. As a results, early prophylactic (EP) PS therapy has been introduced recently in Europe, the US and Korea. However, no multi-center study was compared EP and late selective (LS) PS therapies in Korea. We performed a retrospective multi-center study to compare the outcomes of EP and LS PS therapies in very preterm infants. We analyzed clinical morbidity and mortality for 1,291 infants in 2010 (LS group) and 1,249 infants in 2011 (EP group); the infants were born <30 weeks of gestation and had birth weight < or =1,250 g, and were chosen from 53 neonatal intensive care units in Korea. Compared to the LS group (22.5%), the overall mortality was better in the EP group (19.9%) and there was no increased need for retreatment.There were additional benefits in the EP group such as fewer associated complications. To the best of knowledge, our study is the first nationwide Korean study to compare the outcomes of EP and LS therapies, and it provides evidences that EP PS therapy is important in very preterm infants to improve for survival and reduce morbidities.
Female ; Humans ; Infant, Extremely Premature ; Male ; Prevalence ; Pulmonary Surfactants/*administration & dosage ; Republic of Korea/epidemiology ; Respiratory Distress Syndrome, Newborn/diagnosis/*mortality/*prevention & control ; Risk Factors ; Secondary Prevention/methods/*statistics & numerical data ; Survival Rate ; Treatment Outcome

Pulmonary surfactant (PS) therapy was proven to be highly successful for the treatment of respiratory distress syndrome in premature infants. As a results, early prophylactic (EP) PS therapy has been introduced recently in Europe, the US and Korea. However, no multi-center study was compared EP and late selective (LS) PS therapies in Korea. We performed a retrospective multi-center study to compare the outcomes of EP and LS PS therapies in very preterm infants. We analyzed clinical morbidity and mortality for 1,291 infants in 2010 (LS group) and 1,249 infants in 2011 (EP group); the infants were born <30 weeks of gestation and had birth weight < or =1,250 g, and were chosen from 53 neonatal intensive care units in Korea. Compared to the LS group (22.5%), the overall mortality was better in the EP group (19.9%) and there was no increased need for retreatment.There were additional benefits in the EP group such as fewer associated complications. To the best of knowledge, our study is the first nationwide Korean study to compare the outcomes of EP and LS therapies, and it provides evidences that EP PS therapy is important in very preterm infants to improve for survival and reduce morbidities.
Female ; Humans ; Infant, Extremely Premature ; Male ; Prevalence ; Pulmonary Surfactants/*administration & dosage ; Republic of Korea/epidemiology ; Respiratory Distress Syndrome, Newborn/diagnosis/*mortality/*prevention & control ; Risk Factors ; Secondary Prevention/methods/*statistics & numerical data ; Survival Rate ; Treatment Outcome

OBJECTIVETo investigate the risk factors and preventative measures for neonatal pneumothorax.

METHODSRetrospective analysis was performed on the clinical data of 2286 neonates who were hospitalized in the neonatal intensive care unit between October 2010 and November 2011, and a case-control study was conducted to analyze the risk factors and preventative measures for neonatal pneumothorax.

RESULTSThe incidence of pneumothorax among the neonates was 1.57% (36/2286), and it was significantly higher in full-term infants than in preterm infants (23/1033 vs 13/1253, P=0.023). Logistic regression analysis indicated that cesarean section, neonatal respiratory distress syndrome (NRDS), wet lung, pneumonia and mechanical ventilation were the independent risk factors for neonatal pneumothorax (odds ratios=7.951, 6.090, 7.898, 6.272 and 4.389; P<0.05 for all). The higher the peak inspiratory pressure (PIP) during mechanical ventilation, the higher the incidence of neonatal pneumothorax (P<0.001). Pulmonary surfactant reduced the incidence of pneumothorax among neonates with NRDS (2.9% vs 10.1%; P=0.006).

CONCLUSIONSNeonatal pneumothorax occurs mostly in full-term infants. Cesarean section, NRDS, wet lung, pneumonia and mechanical ventilation are closely associated with neonatal pneumothorax. Strict management of indications for cesarean section, keeping PIP at a low level during mechanical ventilation, and use of pulmonary surfactant are helpful in preventing neonatal pneumothorax.

Case-Control Studies ; Cesarean Section ; adverse effects ; Female ; Humans ; Infant, Newborn ; Logistic Models ; Male ; Pneumothorax ; etiology ; prevention & control ; therapy ; Respiration, Artificial ; adverse effects ; Respiratory Distress Syndrome, Newborn ; complications ; Retrospective Studies

Bronchopulmonary Dysplasia ; prevention & control ; Continuous Positive Airway Pressure ; Humans ; Infant, Newborn ; Neuroprotective Agents ; pharmacology ; Nitric Oxide ; administration & dosage ; Pulmonary Surfactants ; administration & dosage ; Respiratory Distress Syndrome, Newborn ; therapy

OBJECTIVETo evaluate the efficacy and safety of ambroxol in the prevention of respiratory distress syndrome (RDS) in preterm infants.

METHODSElectronic searches were performed in the Cochrane Library, PubMED, EMBASE, Chinese CBM, Chinese VIP Database, Chinese Wanfang Database and Chinese CNKI Database up to the year of 2009 for randomized controlled trials (RCT) on ambroxol for the prevention of RDS in preterm infants. The meeting articles related to the RCT were manually searched in Pediatrics and Pediatric Research. Meta analysis was performed for the results of homogeneous studies by the Cochrane Collaboration's software RevMan 5.0.17.

RESULTSSix RCTs involving 823 preterm infants were included, and the quality assessment for the trials demonstrated 1 article as A class, 1 article as B class and 4 articles as C class. The Meta analysis showed that ambroxol administration significantly reduced the incidence of RDS (OR=0.24, 95%CI: 0.15 - 0.64, P<0.01), bronchopulmonary dysplasis (BPD, OR=0.41, 95%CI: 0.23 - 0.75, P<0.01), intraventricular hemorrhage (IVH, OR=0.39, 95%CI:0.24 - 0.64, P<0.01), patent ductus arteriosus (PDA, OR=0.33, 95%CI: 0.17 - 0.67, P<0.01) and pulmonary infection (OR=0.24, 95%CI:0.14 - 0.38, P<0.01). No adverse events related to the ambroxol treatment were reported.

CONCLUSIONSThe current evidence shows that early use of ambroxol can reduce the risk of RDS, BPD, IVH, PDA and pulmonary infection in preterm infants.

Ambroxol ; therapeutic use ; Bronchopulmonary Dysplasia ; prevention & control ; Cerebral Hemorrhage ; prevention & control ; Ductus Arteriosus, Patent ; prevention & control ; Humans ; Infant, Newborn ; Infant, Premature ; Randomized Controlled Trials as Topic ; Respiratory Distress Syndrome, Newborn ; prevention & control

Ambroxol ; therapeutic use ; Dose-Response Relationship, Drug ; Female ; Humans ; Incidence ; Infant, Newborn ; Male ; Respiratory Distress Syndrome, Newborn ; epidemiology ; mortality ; prevention & control