Clinical trials of medicines in neonates: the influence of ethical and practical issues on design and conduct

scientific article

Clinical trials of medicines in neonates: the influence of ethical and practical issues on design and conduct is …
instance of (P31):
scholarly articleQ13442814

External links are
P356DOI10.1111/BCP.12467
P932PMC publication ID4345948
P698PubMed publication ID25041601

P2093author name stringMark A Turner
P2860cites workRandomized, controlled trial evaluating a baby wash product on skin barrier function in healthy, term neonatesQ24619472
Determining population and developmental pharmacokinetics of metronidazole using plasma and dried blood spot samples from premature infantsQ24626231
Innovative clinical trial design for pediatric therapeuticsQ24635308
Fluconazole pharmacokinetics and safety in premature infantsQ27014816
Randomized trial of drainage, irrigation and fibrinolytic therapy for premature infants with posthemorrhagic ventricular dilatation: developmental outcome at 2 yearsQ28275307
Effect of fluconazole prophylaxis on candidiasis and mortality in premature infants: a randomized clinical trialQ30405312
Azithromycin to prevent bronchopulmonary dysplasia in ureaplasma-infected preterm infants: pharmacokinetics, safety, microbial response, and clinical outcomes with a 20-milligram-per-kilogram single intravenous dose.Q30416493
Accounting for multiple births in neonatal and perinatal trials: systematic review and case studyQ33748656
NeOProM: Neonatal Oxygenation Prospective Meta-analysis Collaboration study protocolQ33793656
Infant skin-cleansing product versus water: a pilot randomized, assessor-blinded controlled trialQ33899049
SCAMP: standardised, concentrated, additional macronutrients, parenteral nutrition in very preterm infants: a phase IV randomised, controlled exploratory study of macronutrient intake, growth and other aspects of neonatal careQ33929561
Managing clinical trialsQ34049734
Extrapolation of adult data and other data in pediatric drug-development programsQ34057100
Neurodevelopmental outcomes in the early CPAP and pulse oximetry trialQ34075235
Developmental pharmacology--drug disposition, action, and therapy in infants and childrenQ34247047
Neuraxial analgesia in neonates and infants: a review of clinical and preclinical strategies for the development of safety and efficacy data.Q34338289
Childhood outcomes after prescription of antibiotics to pregnant women with preterm rupture of the membranes: 7-year follow-up of the ORACLE I trialQ34597346
Randomized controlled trials of antibiotics for neonatal infections: a systematic reviewQ34619963
The impact of neonatal intensive care practices on the developing brainQ34694273
Population pharmacokinetics of metronidazole evaluated using scavenged samples from preterm infantsQ35867330
Risk assessment of neonatal excipient exposure: lessons from food safety and other areas.Q54589926
Parental perception of time and decision-making in neonatal researchQ56781870
Top 15 UK research priorities for preterm birthQ57281265
Newborns and drug studies: The NICHD/FDA newborn drug development initiativeQ58392330
Plasma aminotransferase concentrations in preterm infantsQ61698277
Should newborn infants be excluded from multiple research studies?Q81765186
NO for preterm infants at risk of bronchopulmonary dysplasiaQ84590190
Informed consent in the NICU setting: an ethically optimal model for research solicitationQ35889572
Age terminology during the perinatal periodQ35936113
Population pharmacokinetics of piperacillin using scavenged samples from preterm infantsQ35965812
Neurological and developmental outcome in extremely preterm children born in England in 1995 and 2006: the EPICure studiesQ36445514
TIPIT: A randomised controlled trial of thyroxine in preterm infants under 28 weeks' gestationQ36585122
Clinical trials in neonates and children: Report of the pulmonary hypertension academic research consortium pediatric advisory committee.Q36810827
Improving the quality of consent to randomised controlled trials by using continuous consent and clinician training in the consent processQ36927488
Recruitment to randomised trials: strategies for trial enrollment and participation study. The STEPS studyQ37000038
An explanatory randomised placebo controlled trial of levothyroxine supplementation for babies born <28 weeks' gestation: results of the TIPIT trialQ37014390
Prioritising neonatal medicines research: UK Medicines for Children Research Network scoping surveyQ37324844
Pharmacokinetics of melatonin in preterm infants.Q37369312
Treatment of persistent patent ductus arteriosus in preterm infants: time to accept the null hypothesis?Q37698200
Developmental pharmacokinetics of piperacillin and tazobactam using plasma and dried blood spots from infantsQ37713019
A composite outcome for neonatal cardiac surgery research.Q37731220
A structured review of the recent literature on the economic consequences of preterm birthQ37757783
Long-term effects of neonatal drugs on the kidney.Q37775006
Azithromycin, Ureaplasma and chronic lung disease of prematurity: a case study for neonatal drug developmentQ37893338
Drug studies in newborns: a therapeutic imperativeQ37985058
The long-term renal and cardiovascular consequences of prematurityQ37988805
Measuring neurodevelopmental outcome in neonatal trials: a continuing and increasing challengeQ38120505
Clinical trials in neonatal sepsisQ38125671
Intravenous drug delivery in neonates: lessons learntQ38183808
Paediatric drug development: the impact of evolving regulationsQ38189937
Death, bereavement and randomised controlled trials (BRACELET): a methodological study of policy and practice in neonatal and paediatric intensive care trialsQ39166089
Adverse drug reactions in neonatesQ40743354
Ceftazidime pharmacokinetics in preterm infants: effect of postnatal age and postnatal exposure to indomethacinQ41763473
Long-term effects of indomethacin prophylaxis in extremely-low-birth-weight infantsQ41923576
Glomerular filtration rate reference values in very preterm infantsQ43109210
Postnatal head growth in preterm infants: a randomized controlled parenteral nutrition studyQ43471063
Long-term follow-up of extremely low birth weight infants with neonatal renal failureQ44498147
Modelling the hierarchical structure in datasets with very small clusters: a simulation study to explore the effect of the proportion of clusters when the outcome is continuousQ44563796
Human renal function maturation: a quantitative description using weight and postmenstrual age.Q45281878
Does neonatal morphine use affect neuropsychological outcomes at 8 to 9 years of age?Q45821670
Childhood outcomes after prescription of antibiotics to pregnant women with spontaneous preterm labour: 7-year follow-up of the ORACLE II trialQ46356973
Dose-finding study of ibuprofen in patent ductus arteriosus using the continual reassessment methodQ46422692
Processes in recruitment to randomised controlled trials of medicines for children (RECRUIT): a qualitative studyQ46498288
A gestation- and postnatal age-based reference chart for assessing renal function in extremely premature infantsQ46743368
Blood loss related to participation in pharmacokinetic study in preterm neonates.Q50543758
Management of hypotension in preterm infants (The HIP Trial): a randomised controlled trial of hypotension management in extremely low gestational age newborns.Q50684310
An algorithm to detect adverse drug reactions in the neonatal intensive care unit.Q51260077
P433issue3
P407language of work or nameEnglishQ1860
P921main subjectresearch ethicsQ1132684
medical ethicsQ237151
P304page(s)370-378
P577publication date2015-03-01
P1433published inBritish Journal of Clinical PharmacologyQ176044
P1476titleClinical trials of medicines in neonates: the influence of ethical and practical issues on design and conduct
P478volume79

Reverse relations

cites work (P2860)
Q90225732A universal right to pain relief: balancing the risks in a vulnerable patient population
Q89598857Barriers and Challenges in Performing Pharmacokinetic Studies to Inform Dosing in the Neonatal Population
Q93107049Issues, challenges, and the way forward in conducting clinical trials among neonates: investigators' perspective
Q38469763Neonatal medicines research: challenges and opportunities
Q42586100Paediatric prescribing: why children are not small adults
Q52575612Pharmacokinetic-Pharmacodynamic Modeling in Pediatric Drug Development, and the Importance of Standardized Scaling of Clearance.
Q90745655Recommendations for the design of therapeutic trials for neonatal seizures
Q47428031Safety, dosing, and pharmaceutical quality for studies that evaluate medicinal products (including biological products) in neonates
Q38809090The prevalence of child-specific utilities in NICE appraisals for paediatric indications: rise of the economic orphans?

Search more.