***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: Abstract Early inflammatory lesions and bronchial hyperresponsiveness are characteristics of the respiratory distress in premature neonates and are susceptible to aggravation by assisted ventilation . We hypothesized that treatment with inhaled salbutamol and beclomethasone might be of clinical value in the prevention of bronchopulmonary dysplasia ( BPD ) in ventilator-dependent premature neonates . The study was double-blinded and placebo controlled . We studied 173 infants of less than 31 weeks of gestational age , who needed ventilatory support at the 10th postnatal day . They were r and omised to four groups and received either placebo + placebo , placebo + salbutamol , placebo + beclomethasone or beclomethasone + salbutomol , respectively for 28 days . The major criteria for efficacy were : diagnosis of BPD ( with score of severity ) , mortality , duration of ventilatory support and oxygen therapy . The trial groups were similar with respect to age at entry ( 9.8–10.1 days ) , gestational age ( 27.6–27.8 weeks ) , birth weight and oxygen dependence . We did not observe any significant effect of treatment on survival , diagnosis and severity of BPD , duration of ventilatory support or oxygen therapy . For instance , the odds-ratio ( 95 % confidence interval ) for severe or moderate BPD were 1.04 ( 0.52–2.06 ) for inhaled beclomethasone and 1.54 ( 0.78–3.05 ) for inhaled salbutamol . Conclusion This r and omised prospect i ve trial does not support the use of treatment with inhaled beclomethasone , salbutamol or their combination in the prevention of BPD in premature ventilated neonates An imbalance of proinflammatory cytokines such as TNF-alpha , IL-1 beta , and the neutrophil chemotactic factor IL-8 and inhibitors ( e.g. , soluble TNF receptors and IL-1ra ) in the lung during the first week of life may contribute to prolonged pulmonary inflammation and fibrosis in bronchopulmonary dysplasia ( BPD ) . Disodium cromoglycate ( DSCG ) has anti-inflammatory effects in asthma , a disease with many similarities with BPD . In a prospect i ve , r and omized , blinded study , we examined whether early DSCG therapy inhibits proinflammatory cytokines in infants at risk for BPD . Twenty-six infants who were identified as high risk ( > or = 75 % probability ) for oxygen-dependency at 28 d by a 12-h predictive score and survived 48 h were r and omized to nebulized DSCG 20 mg ( n = 13 ) or 2 cc NS ( control , n = 13 ) every 6 h from Day 3 to Day 28 . Lung lavage was collected on Day 3 ( pre- study ) and Day 7 and analyzed for cell count and differential and TNF-alpha , sTNFR1 , sTNFR2 , IL-1 beta , IL-1ra , and IL-8 concentrations . The groups ' pre- study lavage cytokine concentrations were similar , but TNF-alpha and IL-8 concentrations were 3.6- and 4.9-fold lower in the DSCG group on Day 7 compared with levels in the control group . Soluble TNF receptors were unaffected by DSCG . There was a trend towards lower IL-1 beta levels in DSCG-treated infants on Day 7 , but IL-1ra levels were unaffected by DSCG therapy . Three control subjects , but no DSCG-treated infants , died during the study period ( p = 0.07 ) . There were no significant differences between survivors of the two groups for oxygen-dependency at 28 d ( 100 % control subjects ; 85 % DSCG ) . These results suggest that nebulized DSCG may exert an anti-inflammatory effect in the lungs of infants < or = 1,000 g at risk for BPD Background . Although several trials of early dexamethasone therapy have been completed to determine if such therapy would reduce mortality and chronic lung disease ( CLD ) in infants with respiratory distress , optimal duration and side effects of such therapy remain unknown . Purpose . The purpose of this study was : 1 ) to determine if a 3-day course of early dexamethasone therapy would reduce CLD and increase survival without CLD in neonates who received surfactant therapy for respiratory distress syndrome and 2 ) to determine adverse effects associated with such therapy . Design . This was a prospect i ve multicenter r and omized trial comparing a 3-day course of dexamethasone therapy beginning at 24 to 48 hours of life to placebo therapy .  Two hundred forty-one neonates ( dexamethasone n = 118 , placebon = 123 ) , who weighed between 500 g and 1500 g , received surfactant therapy , and were at significant risk for CLD or death using a model to predict CLD or death at 24 hours of life , were enrolled in the trial . Infants r and omized to receive early dexamethasone  were given 6 doses of dexamethasone at 12-hour intervals beginning at 24 to 48 hours of life . The primary outcomes compared were survival without CLD and CLD . CLD was defined by the need for supplemental oxygen at the gestational age of 36 weeks . Complication rates and adverse effects of study drug therapy were also compared . Results . Neonates r and omized to early dexamethasone treatment were more likely to survive without CLD ( RR : 1.3 ; 95 % CI : 1.03 , 1.7 ) and were less likely to develop CLD ( RR : 0.6 ; CI : 0.3 , 0.98 ) . Mortality rates were not significantly different . Subsequent dexamethasone therapy use was less in early dexamethasone-treated neonates ( RR : 0.8 ; CI : 0.7 , 0.96 ) . Very early ( ≤7 days of life ) intestinal perforations were more common among dexamethasone-treated neonates ( 8 % vs 1 % ) . Conclusion . We conclude that an early 3-day course of dexamethasone therapy increases survival without CLD , reduces CLD , and reduces  late dexamethasone therapy in high-risk , low birth weight infants who receive surfactant therapy for respiratory distress syndrome . Potential benefits of early dexamethasone therapy at the dosing schedule used in this trial need to be weighed against the risk for early intestinal perforation OBJECTIVE Since preventive therapies for bronchopulmonary dysplasia ( BPD ) are limited we treated preterm infants with azithromycin to decrease the incidence of BPD . METHODS Infants less than 1,250 g birth weight were r and omized to azithromycin or placebo within 12 hr of beginning mechanical ventilation and within 72 hr of birth . The treatment group received azithromycin 10 mg/kg/day for 7 days followed by 5 mg/kg/day for a maximum of 6 weeks . Aspirates were collected during the study to assay for Ureaplasma . The primary endpoints were incidence of BPD or mortality . ( Clinical Trials Identifier : NCT00319956 . ) RESULTS A total of 220 infants were enrolled ( n=111 azithromycin , and 109 placebo )  . Mortality was 18 % for the azithromycin group versus 22 % for the placebo group ( P = 0.45 ) . Incidence of BPD was 76 % for the azithromycin group versus 84 % for the placebo group ( P=0.2 ) . The multiple logistic regression analysis demonstrated an odds ratio of 0.46 decrease in the chance of developing BPD or death for the azithromycin group , but was not statistically significant . The incidence of BPD in the Ureaplasma subgroup was 73 % in the azithromycin group versus 94 % in the placebo group ( P=0.03 ) . Analysis of patients in the Ureaplasma subgroup only , using the exact logistic model demonstrated a decrease in BPD or death in the azithromycin group with an estimated odds ratio of 0.026 ( 0.001 - 0.618 , 95 % confidence interval ) . CONCLUSIONS Routine use of azithromycin therapy for the prevention of BPD can not be recommended . The early treatment of Ureaplasma colonized/infected patients might be beneficial , but a larger multi-centered trial is required to assess this more definitively OBJECTIVES To assess the safety-efficacy balance of low-dose inhaled nitric oxide ( iNO ) in hypoxemic premature infants because no sustained beneficial effect has been demonstrated clearly and there are concerns about side effects . STUDY DESIGN Eight hundred and sixty infants < 32 weeks were r and omized at birth to receive 5 ppm iNO or placebo when they presented with hypoxemic respiratory failure ( HRF ) defined by a requirement for mechanical ventilation , fraction of inspired oxygen ( FIO 2 ) > 40 % , and arterio-alveolar ratio in oxygen ( aAO 2 ) < 0.22 . The primary end point was intact survival at 28 days of age . RESULTS Sixty-one of 415 infants presented with HRF and were compared with 84 of 445 controls who presented with HRF . There was no difference in the primary end point ( 61.4 % in infants [ 23 % with HRF who were treated with iNO ] vs 61.1 % in controls [ 21.4 % in controls with HRF ] ; P = .943 ) . For the infants with HRF who were treated with iNO , there was no significant difference from controls for intraventricular hemorrhage ( IVH ) ( 6 % vs 7 % ) , necrotizing enterocolitis ( 8 % vs 6 % ) , or patent ductus arteriosus ( PDA ) ( 34 % vs 37 % ) . Compared with nonhypoxemic infants , the risk of bronchopulmonary displasia ( BPD ) increased significantly in HRF controls ( OR = 3.264 [ CI 1.461 - 7.292 ] ) but not in infants with HRF who were treated with iNO ( OR = 1.626 [ CI 0.633 - 4.178 ] ) . CONCLUSIONS iNO appears to be safe in premature infants but did not lead to a significant improvement in intact survival on day 28 BACKGROUND AND OBJECTIVE : Effective health care for children must be based on thorough analyses of the best research evidence . The objective of this study was to examine registration , completeness , and publication of studies involving children . METHODS : We search ed the Clinical Trials.gov registry to identify all closed studies involving children and examined them for completeness and availability of results . We examined publication in peer- review ed journals for 160 r and omly selected National Institutes of Health (NIH)–funded studies from 2000 through 2010 and for 758 r and omly selected completed studies . RESULTS : Of 3428 closed studies involving children identified in Clinical Trials.gov , 2385 ( 70 % ) were completed , 28 ( 0.8 % ) suspended , 152 ( 4.4 % ) terminated , and 38 ( 1.1 % ) withdrawn . The proportion of non-completed studies ( terminated and suspended ) increased linearly by 186 % between 2001 and 2009 , from 1.9 % to 8.4 % . Of the 152 terminated studies , 48 did not report reasons for termination , 21 cited safety concerns , and 83 cited poor recruitment or other administrative reasons . Only 29 % of completed studies were published . Publication that did occur was an average of 2 years after study completion . Completed interventional studies were published more often than observational studies . Completed industry-funded studies were published less often than studies funded by the NIH . Registered NIH-funded trials were published more often than unregistered . CONCLUSIONS : Results are unavailable for more than half of the studies involving children , revealing a substantial publication bias . Registration and posting of results on Clinical Trials.gov should be m and atory for all studies involving children Abstract Background : Reactive oxygen species have been considered to play a role in several clinical complications in pre-term infants . The aim of this study was to determine the pharmacokinetics of intravenous N-acetylcysteine in pre-term neonates . This information is needed to evaluate the use of N-acetylcysteine as an antioxidant in this patient group . Methods : N-acetylcysteine was infused intravenously in ten patients ( gestational age 24.9–31.0 weeks , weight 500–1384 g ) for 24 h ( 3.4–4.6 mg/kg/h ) , starting 2.0–11.2 h from birth ( study I ) and in six patients ( gestational age 25.9–29.7 weeks , weight 520–1335 g ) for 6 days ( 0.3–1.3 mg/kg/h ) , starting at the age of 24 h ( study II ) . Arterial plasma N-acetylcysteine and cyst(e)ine concentrations were determined from timed sample s taken during ( study I and II ) and after ( study 
    Output:
    
Conclusion : The majority of the drugs studied in RCTs failed to reduce the incidence of BPD .