Background Bronchopulmonary dysplasia (BPD) is the need for oxygen therapy at 36 weeks postmenstrual age (PMA). Sildenafil has been shown to enhance the lung alveolarization and vascularization in newborn animal models after lung injury and has possible therapeutic potential for the prevention of BPD. Objective To perform a proof-of-concept, Phase II, pilot randomized, double-blind, clinical trial to study the efficacy of sildenafil in preventing BPD, in postnatal (< 24 h), extremely and very preterm infants. Methods This Phase II, pilot randomized, double-blind, clinical trial was conducted in the Neonatal Intensive Care Unit of Women's Wellness and Research Center, Doha, Qatar during 2012-2014. Infants of 24 0/7-29 6/7 weeks' gestation were eligible if they needed respiratory or oxygen support ≥ 25% at randomization, and if they were at a postnatal age of < 24 h at randomization. Forty preterm infants were randomly assigned to receive off-label oral sildenafil (0.5 mg/kg every 6 h) or a placebo solution, for one week. The primary endpoints were the incidence of BPD and death at 36 weeks PMA, and the side effects. Secondary outcomes included the incidence of BPD and the respiratory support at day 28 of life, duration of oxygen use, fraction of inspired oxygen use at 36 weeks and 28 days of life, duration of hospitalization, and the incidence of significant retinopathy of prematurity, severe intraventricular hemorrhage, periventricular leukomalacia, necrotizing enterocolitis, patent ductus arteriosus, and late sepsis. Results No significant differences were observed between the sildenafil and placebo study groups in mortality at 36 weeks PMA (10% vs 20%, p = 1), respiratory support at 36 weeks (30% vs 25%, p = 0.57), and side effects (0% vs 0%). For all other secondary outcomes, no significant differences were detected. Conclusions While not associated with side effects, off-label oral sildenafil did not demonstrate benefits in the prevention of BPD or death in the extreme and very preterm infants. Future studies of dosing and efficacy that target different regimens of sildenafil are warranted before sildenafil is recommended for the prevention of BPD.
Background and Objective: The State of Qatar has achieved maternal, neonatal and perinatal survival rates which are comparable to many high income countries, both from the West and East. Our study aims to analyze fetal and perinatal determinants of Qatar's neonatal mortality rate (NMR) during 2011. Methodology: A PEARL Study (Perinatal Neonatal Outcomes Research Study in the Arabian Gulf), a joint collaborative research project between Hamad Medical Corporation (HMC) Qatar and University of Gloucestershire United Kingdom, is Qatar's prospective national perinatal epidemiological Study funded by Qatar National Research Fund. The study is quantifying maternal, neonatal and perinatal mortality, morbidities and their correlates by establishing a national neonatal perinatal registry for Qatar called Q-Peri-Reg. Data on live births and neonatal mortality were collected from all public and private maternity facilities in Qatar during 2011. Data on fetal and perinatal determinants was ascertained from maternal obstetric and delivery room record on predesigned performas. Univariate and multivariate regression analysis was done using Epi Info and SPSS-20. Results: Qatar's NMR during 2011 was 4.9. The incidence of low birth weight in Qatar is 11% and the incidence of preterm deliveries 10.7%. 10% of the babies required delivery room resuscitation. The relative risk of neonatal mortality was higher and statistically significant with fetal growth (p<0.001), fetal weight at birth (p<0.001), fetal gestation at birth (p<0.001), APGAR score at 1 and 5 minute (p<0.001) and the need for delivery room resuscitation (p<0.001). The RR of neonatal mortality increased (Table 1) with decreasing birth weight (p<0.001) and gestational age (p<0.001). Conclusion: Further improvement in Qatar's neonatal mortality is possible by addressing the high incidence of low birth weight and preterm deliveries. Better maternal nutrition, improved antenatal care, birth spacing and best obstetric and neonatal practices at delivery are likely to be most helpful.
BACKGROUND: Transient tachypnea of the newborn (TTN) is a self-limited increase in the work of breathing in near-and full-term infants; it is attributed to a delay in the clearance of alveolar fluids. Prophylactic antibiotics are usually administered until blood cultures are reported negative for 48 hours. OBJECTIVES: To prospectively compare outcomes of infants presented with classic TTN who were treated with or denied from intravenous antibiotics. METHODS: A prospective cohort study was conducted on all infants admitted with classic TTN. Pre-set diagnostic criteria for classic TTN were applied in order to exclude other cases presenting with respiratory distress. Infants with classic TTN were stratified into two groups based on whether they received or did not receive antibiotics. The decision to administer antibiotics solely depended upon the style of the covering physician at the time of admission to the NICU. The following investigations were obtained from infants of both groups: blood culture, C-reactive protein, complete blood count, blood gas profile and chest X-ray. RESULTS: A total of 15146 full-term infants were delivered during the study period; of them 923 were admitted to the NICU. Classic TTN was diagnosed in 168 infants; of them 106 (63%) received and 62 (37%) did not receive antibiotics. Two infants in the treated group and an infant in the non-treated group had microbiologically confirmed bacteremia. Infants in the treatment group stayed longer in the hospital (72 ± 6 vs. 48 ± 3 hrs). No recorded cases required readmission in either group. CONCLUSIONS: With the application of strict criteria for classic TTN and the close observation in the NICU, the empiric use of antibiotics may be avoidable. Randomized controlled trials are needed to confirm the feasibility and safety of such approach.
infliximab, respectively, were necessary in order to achieve similar levels of cost-effectiveness as secukinumab, whereas discounts as high as 90% for etanercept, 60% for ustekinumab, 55% for adalimumab and 50% for infliximab were necessary to reach similar levels of cost-effectiveness as ixekizumab and brodalumab. Conclusion According to this economic model, modern anti-IL-17s are highly cost-effective compared to anti-TNFs and anti-IL-12/23. Though discounts may be a way of making anti-TNFs and anti-IL-12/23 more cost-effective, this study indicates that very high levels of discounts would be necessary to achieve this.
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