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In this trial, preterm infants who needed ventilatory assistance were randomly assigned to receive initial treatment with nasal continuous positive pressure (CPAP) ventilation, followed by intubation if their condition deteriorated, or immediate intubation and mechanical support. Although there were more pneumothoraxes and fewer days of mechanical ventilation in the CPAP group, there was no difference in mortality or bronchopulmonary dysplasia between the two groups. Preterm infants who needed ventilatory assistance were randomly assigned to receive nasal continuous positive airway pressure (CPAP) or intubation. Although there were more pneumothoraxes and fewer days of mechanical ventilation in the CPAP group, there was no difference in mortality or bronchopulmonary dysplasia between the two groups. For two decades, the standard treatment for very preterm infants was with assisted ventilation and surfactant. 1 , 2 However, since ventilation may damage the lungs, 3 , 4 it has been hypothesized that the avoidance of ventilation might lead to less bronchopulmonary dysplasia. Bronchopulmonary dysplasia 5 , 6 is a major cause of mortality and morbidity in very preterm infants. 7 Despite the increased use of antenatal corticosteroids, 8 surfactant, 9 and improved ventilation techniques, the incidence has not decreased. 10 , 11 Observational studies of variations in clinical practice have suggested that treating very preterm infants with nasal continuous positive airway pressure (CPAP) during resuscitation is possible and may . . .

This randomized double-blind placebo-controlled trial evaluated the effects of early postnatal oral vitamin A supplementation (VAS) in 196 inborn very-low birth weight (VLBW) infants requiring respiratory support at 24 h of age. Eligible infants were randomized to receive aqueous syrup of vitamin A (10,000 IU of retinol/dose; n = 98) or placebo (n = 98) on alternate days for 28 days. Primary outcome variable was composite incidence of all-cause mortality and/or oxygen requirement for 28 days. Secondary outcome variables were safety/tolerability of VAS, serum retinol concentration at recruitment and day 28, duration of oxygen requirement and respiratory support and incidences of complications. On intention-to-treat analysis, composite incidence of all-cause mortality and oxygen requirement for 28 days was significantly lower in vitamin A group (relative risk (95% confidence interval), 0.440 (0.229–0.844); p < 0.05, number needed to benefit, 7). Requirement and duration of oxygen supplementation and non-invasive respiratory support, incidences of late-onset sepsis, patent ductus arteriosus, and duration of hospital stay were also significantly lower in vitamin A group. Serum retinol concentration improved significantly after VAS. No major adverse effect was observed.Conclusions: Early postnatal oral VAS was associated with better composite outcome of all-cause mortality and oxygen requirement without any major adverse effects.Clinical Trial Registration: Clinical Trials Registry of India (CTRI/2017/03/008131).What is Known:• Postnatal intramuscular vitamin A supplementation improves the survival, respiratory outcome and other morbidities in very low birth weight neonates without major adverse effects.• Limited studies on oral vitamin A supplementation did not document substantial benefits.What is New:• Early postnatal alternate-day oral vitamin A supplementation at the dose of 10,000 IU/dose for 28 days improves the composite outcome of death and oxygen requirement in very low birth weight neonates with respiratory distress• No major adverse effects were documented

Less invasive surfactant administration (LISA) is a method to deliver surfactant to spontaneously breathing premature infants via a thin catheter. Here we report the two-year outcome from the AMV (avoid mechanical ventilation) study, the first randomized controlled trial on this mode of surfactant delivery. No statistically significant differences in weight, length or neurodevelopmental outcome (Bayley II scores) were found between the LISA intervention group (n = 95) and the control group (n = 84) that received standard treatment.Conclusion: No differences in outcome were observed at 2 years. LISA seems safe in that aspect.What is Known:• LISA is a method that is in increasing use for surfactant delivery to spontaneously breathing infants. LISA reduces the need for mechanical ventilation.What is New:• Outcome data at 2 years from the first randomized study with LISA raise no safety concerns in comparison to a group of infants that received standard treatment.

Background It is now recognized that preterm infants ≤28 weeks gestation can be effectively supported from the outset with nasal continuous positive airway pressure. However, this form of respiratory therapy may fail to adequately support those infants with significant surfactant deficiency, with the result that intubation and delayed surfactant therapy are then required. Infants following this path are known to have a higher risk of adverse outcomes, including death, bronchopulmonary dysplasia and other morbidities. In an effort to circumvent this problem, techniques of minimally-invasive surfactant therapy have been developed, in which exogenous surfactant is administered to a spontaneously breathing infant who can then remain on continuous positive airway pressure. A method of surfactant delivery using a semi-rigid surfactant instillation catheter briefly passed into the trachea (the “Hobart method”) has been shown to be feasible and potentially effective, and now requires evaluation in a randomised controlled trial. Methods/design This is a multicentre, randomised, masked, controlled trial in preterm infants 25–28 weeks gestation. Infants are eligible if managed on continuous positive airway pressure without prior intubation, and requiring FiO 2  ≥ 0.30 at an age ≤6 hours. Randomisation will be to receive exogenous surfactant (200 mg/kg poractant alfa) via the Hobart method, or sham treatment. Infants in both groups will thereafter remain on continuous positive airway pressure unless intubation criteria are reached (FiO 2  ≥ 0.45, unremitting apnoea or persistent acidosis). Primary outcome is the composite of death or physiological bronchopulmonary dysplasia, with secondary outcomes including incidence of death; major neonatal morbidities; durations of all modes of respiratory support and hospitalisation; safety of the Hobart method; and outcome at 2 years. A total of 606 infants will be enrolled. The trial will be conducted in >30 centres worldwide, and is expected to be completed by end-2017. Discussion Minimally-invasive surfactant therapy has the potential to ease the burden of respiratory morbidity in preterm infants. The trial will provide definitive evidence on the effectiveness of this approach in the care of preterm infants born at 25–28 weeks gestation. Trial registration Australia and New Zealand Clinical Trial Registry: ACTRN12611000916943 ; ClinicalTrials.gov: NCT02140580 .

Surfactant treatment has revolutionized the management of respiratory distress syndrome (RDS) in preterm infants. The present study compared the effectiveness and adverse effects of two natural surfactants, Beracsurf and Curosurf, in premature infants with RDS who required surfactant administration. Eighty-four newborns were enrolled in this double-blind randomized controlled trial study, which was conducted in Shiraz, Iran, from 2021 to 2022. The study included all preterm neonates with RDS, who required intubation for stabilization, were on continuous positive airway pressure (CPAP), required oxygen of more than 30% to maintain saturation 90-95%, or had CPAP failure. Using a simple random allocation method, the participants were randomly assigned to receive either Beractant as the case group or Proctant Alpha as the control group. The study assessed outcomes such as hospital length, number of surfactant administration, duration of respiratory support, complications, and mortality in both groups. Data were analyzed using SPSS software and applying independent t tests, Mann-Whitney tests, and Chi square tests. Eighty-four neonates were enrolled in the study, with 37 in the control group and 47 in the case group. The duration of hospital stay in the control group was 18.07±13.04 days, while it was 23.59±14.03 days in the intervention group (P=0.07). There were no differences between the two groups in terms of the fraction of inspired oxygen (FIO ) (P=0.46), and complications (P=0.82). However, the intubation period in the Curosurf group was significantly lower (P=0.03). The mortality rate in the Curosurf group was 24.3% (95% CI=10.5%-38.1%); while in the Beracsurf group, it was 10.6% (95% CI=1.8%-19.5%) (P=0.09). Beracsurf had comparable efficacy to Curosurf and could be considered a viable alternative. IRCT20120126008827N3.

In this randomized, placebo-controlled trial involving premature infants (less than 34 weeks' gestation) with the respiratory distress syndrome, the use of inhaled nitric oxide significantly reduced the incidence of chronic lung disease and death. This therapy also reduced the rate of severe intraventricular hemorrhage and periventricular leukomalacia — important complications of prematurity. Benefits for premature infants with respiratory distress. Chronic lung disease remains the primary long-term pulmonary complication among premature infants and is associated with pulmonary hypertension as well as abnormalities of postnatal alveolarization and neovascularization. 1 In addition to having impaired growth, 2 infants with chronic lung disease may have poor long-term cardiopulmonary function, an increased susceptibility to infection, 3 and a sharply increased risk of abnormal neurologic development. 4 Nitric oxide attenuates pulmonary vascular disease, inflammation, and pulmonary hypertension in newborns with lung injury. 5 – 7 Accordingly, we hypothesized that the use of inhaled nitric oxide would decrease the incidence of chronic lung disease and death in premature infants with the respiratory . . .

This multicenter trial comparing nasal high-flow therapy with CPAP as primary support for preterm infants with respiratory distress showed a significantly higher treatment-failure rate with high-flow therapy. In 2014, there were more than 380,000 preterm births (i.e., births at a gestational age of <37 weeks) in the United States, accounting for approximately 10% of all births that year. 1 Preterm infants have a risk of the respiratory distress syndrome. The introduction of endotracheal ventilation has improved the survival rate among preterm infants but is associated with an increased risk of complications such as bronchopulmonary dysplasia. 2 Clinicians aim to use noninvasive respiratory support to minimize the risk of such complications. The most widely used noninvasive approach, nasal continuous positive airway pressure (CPAP), has been shown to be an effective . . .

Bronchopulmonary dysplasia (BPD) is an important complication of mechanical ventilation in preterm infants, and no definite therapy can eliminate this complication. Pulmonary inflammation plays a crucial role in its pathogenesis, and glucocorticoid is one potential therapy to prevent BPD. To compare the effect of intratracheal administration of surfactant/budesonide with that of surfactant alone on the incidence of death or BPD. A clinical trial was conducted in three tertiary neonatal centers in the United States and Taiwan, in which 265 very-low-birth-weight infants with severe respiratory distress syndrome who required mechanical ventilation and inspired oxygen (fraction of inspired oxygen, ≥50%) within 4 hours of birth were randomly assigned to one of two groups (131 intervention and 134 control). The intervention infants received surfactant (100 mg/kg) and budesonide (0.25 mg/kg), and the control infants received surfactant only (100 mg/kg), until each infant required inspired O2 at less than 30% or was extubated. The intervention group had a significantly lower incidence of BPD or death (55 of 131 [42.0%] vs. 89 of 134 [66%]; risk ratio, 0.58; 95% confidence interval, 0.44-0.77; P < 0.001; number needed to treat, 4.1; 95% confidence interval, 2.8-7.8). The intervention group required significantly fewer doses of surfactant than did the control group. The intervention group had significantly lower interleukin levels (IL-1, IL-6, IL-8) in tracheal aspirates at 12 hours and lower IL-8 at 3-5 and 7-8 days. In very-low-birth-weight infants with severe respiratory distress syndrome, intratracheal administration of surfactant/budesonide compared with surfactant alone significantly decreased the incidence of BPD or death without immediate adverse effect. Clinical trial registered with www.clinicaltrials.gov (NCT-00883532).

Intratracheal administration of exogenous surfactant is a well-established therapy for respiratory distress syndrome in preterm infants. The two preferred methods for respiratory support in neonates that contribute to limiting the risk of lung damage associated with mechanical ventilation include nCPAP and non-invasive ventilation. The increasing popularity of surfactant administration techniques is due to the fact they reduce the time of mechanical ventilation until this medication is administered. In some cases a short period of mechanical ventilation follows (INSURE: INtubation-SURfactant-Extubation). There are also methods that make it possible to completely avoid intubation and help maintain spontaneous breathing during surfactant administration (LISA: Less Invasive Surfactant Administration, MIST: Minimal Invasive Surfactant Therapy).

Purpose Nasal continuous positive airway pressure (nCPAP) is currently the gold standard for respiratory support for moderate to severe acute viral bronchiolitis (AVB). Although oxygen delivery via high flow nasal cannula (HFNC) is increasingly used, evidence of its efficacy and safety is lacking in infants. Methods A randomized controlled trial was performed in five pediatric intensive care units (PICUs) to compare 7 cmH 2 O nCPAP with 2 L/kg/min oxygen therapy administered with HFNC in infants up to 6 months old with moderate to severe AVB. The primary endpoint was the percentage of failure within 24 h of randomization using prespecified criteria. To satisfy noninferiority, the failure rate of HFNC had to lie within 15% of the failure rate of nCPAP. Secondary outcomes included success rate after crossover, intubation rate, length of stay, and serious adverse events. Results From November 2014 to March 2015, 142 infants were included and equally distributed into groups. The risk difference of −19% (95% CI −35 to −3%) did not allow the conclusion of HFNC noninferiority ( p  = 0.707). Superiority analysis suggested a relative risk of success 1.63 (95% CI 1.02–2.63) higher with nCPAP. The success rate with the alternative respiratory support, intubation rate, durations of noninvasive and invasive ventilation, skin lesions, and length of PICU stay were comparable between groups. No patient had air leak syndrome or died. Conclusion In young infants with moderate to severe AVB, initial management with HFNC did not have a failure rate similar to that of nCPAP. This clinical trial was recorded in the National Library of Medicine registry (NCT 02457013).