Abstract：Real world study (RWS) has attracted more and more attention of neonatologists since it involves less clinical intervention and is closer to actual clinical conditions. Generally speaking, RWS means to select treatment measures based on the internal efficacy and safety verified by randomized controlled trials (RCTs), more representative samples, and patients' actual conditions and their guardians' will and conduct follow-up evaluation of short-and long-term outcomes, in order to further evaluate the external efficacy and safety of interventional measures. Most guidelines for clinical practice are based on RCTs and lack the support of real world data. Strengthening of neonatal RWS helps to make these guidelines more practical and thus promotes the development of neonatal medicine.
Henderson-Smart DJ, Steer PA. Caffeine versus theophylline for apnea in preterm infants[J]. Cochrane Database Syst Rev, 2010, (1):CD000273.
[3]
Henderson-Smart DJ, Davis PG. Prophylactic methylxanthines for extubation in preterm infants[J]. Cochrane Database Syst Rev, 2003, (1):CD000139.
[4]
Schmidt B, Roberts RS, Davis P, et al. Caffeine therapy for apnea of prematurity[J]. N Engl J Med, 2006, 354(20):2112-2121.
[5]
Schmidt B, Roberts RS, Davis P, et al. Long-term effects of caffeine therapy for apnea of prematurity[J]. N Engl J Med, 2007, 357(19):1893-1902.
[6]
Schmidt B, Anderson PJ, Doyle LW, et al. Survival without disability to age 5 years after neonatal caffeine therapy for apnea of prematurity[J]. JAMA, 2012, 307(3):275-282.
[7]
Dukhovny D, Lorch SA, Schmidt B, et al. Economic evaluation of caffeine for apnea of prematurity[J]. Pediatrics, 2011, 127(1):e146-e155.
[8]
Schoen K, Yu T, Stockmann C, et al. Use of methylxanthine therapies for the treatment and prevention of apnea of prematurity[J]. Paediatr Drugs, 2014, 16(2):169-177.
[9]
Lista G, Fabbri L, Polackova R, et al. The real-world routine use of caffeine citrate in preterm infants:a European postauthorization safety study[J]. Neonatology, 2016, 109(3):221-227.
Vázquez-Baeza Y, Callewaert C, Debelius J, et al. Impacts of the human gut microbiome on therapeutics[J]. Annu Rev Pharmacol Toxicol, 2018, 58:253-270.
[12]
De Luca D, van Kaam AH, Tingay DG, et al. The Montreux definition of neonatal ARDS:biological and clinical background behind the description of a new entity[J]. Lancet Respir Med, 2017, 5(8):657-666.
[13]
Pediatric Acute Lung Injury Consensus Conference Group. Pediatric acute respiratory distress syndrome:consensus recommendations from the Pediatric Acute Lung Injury Consensus Conference[J]. Pediatr Crit Care Med, 2015, 16(5):428-439.
[14]
U.S. House Energy and Commerce Committee. Text of house amendment to the senate amendment to H.R.34, Tsunami Warning, Education and Research Act of 2015[DB/OL].
[15]
Sherman RE, Anderson SA, Dal Pan GJ, et al. Real-world evidence-What is it and what can it tell us?[J]. N Engl J Med, 2016, 375(23):2293-2297.
Stefanescu BM, Murphy WP, Hansell BJ, et al. A randomized, controlled trial comparing two different continuous positive airway pressure systems for the successful extubation of extremely low birth weight infants[J]. Pediatrics, 2003, 112(5):1031-1038.
[18]
Bhandari V. Nasal intermittent positive pressure ventilation in the newborn:review of literature and evidence-based guidelines[J]. J Perinatol, 2010, 30(8):505-512.
[19]
Tang S, Zhao J, Shen J, et al. Nasal intermittent positive pressure ventilation versus nasal continuous positive airway pressure in neonates:a systematic review and meta-analysis[J]. Indian Pediatr, 2013, 50(4):371-376.
[20]
Meneses J, Bhandari V, Alves JG. Nasal intermittent positive-pressure ventilation vs nasal continuous positive airway pressure for preterm infants with respiratory distress syndrome:a systematic review and meta-analysis[J]. Arch Pediatr Adolesc Med, 2012, 166(4):372-376.
[21]
Lemyre B, Laughon M, Bose C, et al. Early nasal intermittent positive pressure ventilation (NIPPV) versus early nasal continuous positive airway pressure (NCPAP) for preterm infants[J]. Cochrane Database Syst Rev, 2016, 12:CD005384.
[22]
Meneses J, Bhandari V, Alves JG, et al. Noninvasive ventilation for respiratory distress syndrome:a randomized controlled trial[J]. Pediatrics, 2011, 127(2):300-307.
[23]
Kirpalani H, Millar D, Lemyre B, et al. A trial comparing noninvasive ventilation strategies in preterm infants[J]. N Engl J Med, 2013, 369(7):611-620.
[24]
Li W, Long C, Zhangxue H, et al. Nasal intermittent positive pressure ventilation versus nasal continuous positive airway pressure for preterm infants with respiratory distress syndrome:a meta-analysis and up-date[J]. Pediatr Pulmonol, 2015, 50(4):402-409.
[25]
Chen L, Wang L, Li J, et al. Noninvasive ventilation for preterm twin neonates with respiratory distress syndrome:a randomized controlled trial[J]. Sci Rep, 2015, 5:14483.
