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- The need for rigorous evidence on medication use in preterm infants: is it time for a neonatal rule?.JAMA. 2012; 308: 1435-1436https://doi.org/10.1001/jama.2012.12883
- Development of drug therapies for newborns and children: the scientific and regulatory imperatives.Pediatr Clin. 2017; 64: 1185-1196https://doi.org/10.1016/j.pcl.2017.08.015
- General clinical pharmacology considerations for neonatal studies for drugs and biological products.2019
- March of dimes report card.2019
- Newborns, one of the last therapeutic orphans to be adopted.JAMA Pediatr. 2014; 168: 106-108https://doi.org/10.1001/jamapediatrics.2013.4604
- Global shortage of neonatal and paediatric antibiotic trials: rapid review.BMJ Open. 2017; 7e016293https://doi.org/10.1136/bmjopen-2017-016293
Inomax, U.S. Prescribing Information, https://www.inomax.com/wp-content/themes/inomax-website/dist/downloads/Inomax-PI.pdf Accessed:.
Clinical Trials. Gov, PPHN neonates, https://clinicaltrials.gov/ct2/results?cond=PPHN&term=neonates+vasodilator&cntry=&state=&city=&dist= Accessed: 25 February 2022.
- 21st Century Cures Act.in: HR 34, 114th congress, enacted on dec 13. 2016
- Submitting documents using real-world data and real-world evidence to FDA for drugs and biologics.2019
U.S. Food and Drug Administration, Consideration on use of RWD and RWE, https://www.fda.gov/regulatory-information/search-fda-guidance-documents/considerations-use-real-world-data-and-real-world-evidence-support-regulatory-decision-making-drug 2021 Accessed: 25 February 2022.
European Medicines Agency, Use of Real World Evidence, https://www.ema.europa.eu/en/news/vision-use-real-world-evidence-eu-medicines-regulation Accessed: 25 February 2022.
- Marketing authorization applications made to the European Medicines agency in 2018-2019: what was the contribution of real-world evidence?.Clin Pharmacol Ther. 2022; 111: 90-97https://doi.org/10.1002/cpt.2461
- Development of a neonatal adverse event severity scale through a Delphi consensus approach.Arch Dis Child. 2019; 104: 1167-1173https://doi.org/10.1136/archdischild-2019-317399
- Clinical laboratory reference intervals in pediatrics: the CALIPER initiative.Clin Biochem. 2009; 42: 1589-1595https://doi.org/10.1016/j.clinbiochem.2009.06.025
- The CBC: reference ranges for neonates.Semin Perinatol. 2009; 33: 3-11https://doi.org/10.1053/j.semperi.2008.10.010
- Reference intervals for reticulocyte parameters of infants during their first 90 days after birth.J Perinatol. 2016; 36: 61-66https://doi.org/10.1038/jp.2015.140
- Pediatric pulmonary hypertension: definitions, mechanisms, diagnosis, and treatment.Compr Physiol. 2021; 11: 2135-2190https://doi.org/10.1002/cphy.c200023
IBM, IBM Explorys EHR database, https://www.ibm.com/watson-health/about/explorys Accessed:.
Optum Clinformatics, Clinformatics Data Mart https://www.optum.com/content/dam/optum/resources/productSheets/Clinformatics_for_Data_Mart.pdf Accessed: 25 February 2022.
- Multiscale classification of heart failure phenotypes by unsupervised clustering of unstructured electronic medical record data.Sci Rep. 2020; 10: 21340https://doi.org/10.1038/s41598-020-77286-6
- Synthetic and external controls in clinical trials - a primer for researchers.Clin Epidemiol. 2020; 12: 457-467https://doi.org/10.2147/clep.S242097
- IGF-I in the clinics: use in retinopathy of prematurity.Growth Hormone IGF Res. 2016; 30–31: 75-80https://doi.org/10.1016/j.ghir.2016.09.005
- Retinopathy of prematurity.Lancet. 2013; 382: 1445-1457https://doi.org/10.1016/S0140-6736(13)60178-6
- Treatment of retinopathy of prematurity: a review of conventional and promising new therapeutic options.Int J Ophthalmol. 2013; 6: 228-236https://doi.org/10.3980/j.issn.2222-3959.2013.02.23
- A systematic review and meta-analysis on the safety of vascular endothelial growth factor (VEGF) inhibitors for the treatment of retinopathy of prematurity.PLoS One. 2015; 10: 1-16https://doi.org/10.1371/journal.pone.0129383
- Structural, visual and refractive outcomes of intravitreal aflibercept injection in high-risk prethreshold type 1 retinopathy of prematurity.Ophthalmic Res. 2015; 53: 15-20https://doi.org/10.1159/000364809
- Ranibizumab versus laser therapy for the treatment of very low birthweight infants with retinopathy of prematurity (RAINBOW): an open-label randomised controlled trial.Lancet. 2019; 394: 1551-1559https://doi.org/10.1016/s0140-6736(19)31344-3
- Summarizing historical information on controls in clinical trials.Clin Trials. 2010; 7: 5-18https://doi.org/10.1177/1740774509356002
- Bronchopulmonary dysplasia: new becomes old again.Pediatr Res. 2017; 81: 210-213https://doi.org/10.1038/pr.2016.201
- Revisiting the definition of bronchopulmonary dysplasia: effect of changing panoply of respiratory support for preterm neonates.JAMA Pediatr. 2017; 171: 271-279https://doi.org/10.1001/jamapediatrics.2016.4141
- The discovery BPD (D-BPD) program: study protocol of a prospective translational multicenter collaborative study to investigate determinants of chronic lung disease in very low birth weight infants.BMC Pediatr. 2019; 19: 227https://doi.org/10.1186/s12887-019-1610-8