During the period between 1999 and 2005, a clinical trial has been conducted at Hung Vuong Hospital to assess the efficacy of surfactant replacement therapy for prevention and treatment of respiratory distress syndrome (RDS) in preterm infants. Results: A total of 83 preterm infants with gestational age from 27 to 33 weeks were recruited, of whom 45 assigned to the prophylactic group and 38 to the rescue group. Percentages of developing or not reassuring RDS were 5.4% and 21.1% in the prophylactic and the rescue group, respectively (p<0.001). However, the difference in neonatal mortality was not statistically significant: 8.9% in the prophylactic in comparison with 15.8% in the rescue group
Respiratory Distress Syndrome, Adult ; Respiratory Distress Syndrome ; Newborn ; Therapeutics ; Pulmonary Surfactants ; Prevention & control ; Therapeutics

BACKGROUNDNeonatal respiratory distress syndrome (NRDS) is caused by a deficiency in pulmonary surfactant (PS) and is one of the main reasons of neonatal mortality. This study was conducted to evaluate the efficacy and safety of intra-amniotic administration of pulmonary surfactant for prophylaxis of NRDS.

METHODSForty-five pregnant women who were due for preterm delivery and whose fetuses' lungs proved immature were divided into two groups. Fifteen women (study group) were administered one dose of pulmonary surfactant injected into the amniotic cavity and delivered within several hours. Nothing was injected into the amniotic cavity of 30 women of the control group. The proportion of neonatal asphyxia, NRDS, mortality and the time in hospital were analyzed to determine if there was any difference between the two groups.

RESULTSThere was no significant difference between the two groups for neonatal asphyxia. Foam tests showed that higher proportion of neonates in the study group than in the control group (56.3% vs 13.3%, P < 0.05) had lung maturity. A greater number of control neonates (11/30, 32.3%) had NRDS, compared with the neonates given PS via the amniotic cavity before delivery (1/16, 6.3%, P < 0.05). The neonates in the study group spent nearly 10 days less in hospital than the control group [(32.4 +/- 7.6) days vs (42.0 +/- 15.7) days, P < 0.05], but the difference in mortality between the two groups was not statistically significant.

CONCLUSIONSIntra-amniotic administration of pulmonary surfactant can significantly reduce the proportion of NRDS and the time in hospital of preterm neonates. Whether this method can reduce the mortality of preterm neonates needs to be evaluated further. Intra-amniotic administration of pulmonary surfactant provides an additional effectual means for NRDS prophylaxis.

Amnion ; Female ; Humans ; Infant, Newborn ; Pulmonary Surfactants ; administration & dosage ; Respiratory Distress Syndrome, Newborn ; prevention & control ; Safety ; Treatment Outcome

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

OBJECTIVEAmbroxol induces the synthesis of surfactant in lung alveolar type II cells. Some studies have shown its effectiveness for the prevention of respiratory distress syndrome (RDS) in preterm infants. This study aimed to compare the efficacy of two different ways of ambroxol administration, ie, intravenous injection and atomizing inhalation, for the prevention of RDS in preterm infants.

METHODSA total of 125 preterm infants born between 28-37 weeks of gestation were randomly assigned into three groups: Intravenous and Atomizing ambroxol treatment groups (n=40 each) or Control group (n=45). The Intravenous group was injected with 15 mg/kg of ambroxol through the umbilical vein immediately after birth and then received 30 mg/kg of ambroxol daily for 2 days by intravenous drip. The Atomizing group was administered with 30 mg/kg of ambroxol daily for 2 days by atomizing inhalation immediately after birth. The Control group received no ambroxol treatment. The incidences of RDS and complications as well as the blood gas results 6 hrs after birth were compared among the three groups.

RESULTSThe incidence of RDS was 7.5%, 5.0% and 24.4% in the Intravenous, Atomizing and Control groups respectively. There were no significant differences in the incidence of RDS between the two ambroxol treatment groups. However, the incidence of RDS in the two treatment groups were noticeably lower than in the Control group (P < 0.05). The blood gas results did not show significant differences between the two ambroxol treatment groups but both groups demonstrated improved blood gas results compared with the Control group at 6 hrs after birth (P < 0.05). The incidence of complications, such as pulmonary hemorrhage, respiratory failure, intraranial hemorrhage, in the two ambroxol treatment groups was reduced compared with the Control group (P < 0.05), but there were no differences between the two ambroxol groups.

CONCLUSIONSEarly administration of either intravenous or atomizing ambroxol can produce a positive efficacy for the prevention of RDS in preterm infants. The two different ways of administration seem to result in a similar efficacy in the prevention of RDS.

Administration, Inhalation ; Ambroxol ; administration & dosage ; adverse effects ; pharmacology ; Female ; Humans ; Infant, Newborn ; Infant, Premature ; Injections, Intravenous ; Male ; Pulmonary Surfactants ; metabolism ; Respiratory Distress Syndrome, Newborn ; prevention & control

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

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

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

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 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

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