Intravenous drug delivery in neonates: lessons learnt

Sherwin, Catherine M.T.; Medlicott, Natalie J.; Reith, David; Broadbent, Roland

doi:10.1136/archdischild-2013-304887

Cited by 48 publications

(44 citation statements)

References 45 publications

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“…Increased syringe size will result in increased bolus volume caused by vertical displacement. Clinicians need to be aware of flow variability, which has been highlighted in a number of animal studies [47,48,49,50]. …”

Section: What Interventions Should Be Used?mentioning

confidence: 99%

What Should We Do about Low Blood Pressure in Preterm Infants

Dempsey¹

2017

Neonatology

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The management of preterm infants with low blood pressure soon after birth remains unresolved. The definition of what constitutes low blood pressure is uncertain. At birth, mean blood pressure appears to be gestation specific and increases in the first few days of life. Antenatal steroids, delayed cord clamping, and the avoidance of mechanical ventilation are all associated with higher mean blood pressure and less hypotension after birth. Rates of hypotension of 15-50% have been reported in various studies of extremely preterm infants. However, only about 10% of all extremely preterm infants receive inotropes, suggesting that clinicians take into account other factors such as clinical, biochemical, and echocardiographic findings before deciding to intervene. The exact role of functional echocardiography in assessing the need for treatment of low blood pressure in extremely preterm infants remains to be determined. Near- infrared spectroscopy to assess cerebral perfusion may also have a role to play. Volume expansion (usually 10 mL/kg of saline) remains the most commonly used intervention for low blood pressure but evidence of benefit is lacking and there may be safety concerns. Whilst dopamine is the most commonly used inotropic drug, dobutamine, epinephrine, corticosteroids, milrinone, and vasopressin have also been utilised in preterm infants with low blood pressure. Clinical trials with long-term outcomes are needed to determine the most suitable inotrope and when to use it. Early hypotension differs from late hypotension with regard to cause, treatment, and outcome. A number of recent studies aimed at improving the evidence base for the treatment of early hypotension in extremely preterm infants have been terminated early because of poor recruitment. Currently, the answer to the question of what to do about low blood pressure in preterm infants remains unclear.

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Section: What Interventions Should Be Used?mentioning

confidence: 99%

What Should We Do about Low Blood Pressure in Preterm Infants

Dempsey¹

2017

Neonatology

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“…These challenges arise from slow intravenous flow rates, small drug volume, dead space volume, excipients, and limitations on the flush volume that can be given in neonates. An appreciation of the substantial delay and variability in the rate of drug delivery from the intravenous line is often lacking, but the available knowledge on this aspect has recently been summarized [13]. Knowledge on neonatal drug delivery has advanced, but there is still a deficiency of technologies and formulations developed specifically for this population.…”

Section: Neonatal Clinical Pharmacy: How To Cope With Neonatal Formulmentioning

confidence: 99%

“…As a recent illustration, we refer to the evaluation of the use of uncoated mini-tablets instead of syrup for neonates. Uncoated mini-tablets offer the potential of a single formulation for different age groups and [5,6,10,11,13,15], and pharmacovigilance [7,8] in neonates, but should also shift towards medicines and product development driven by neonatal pathophysiology [9] avoid the need for specific excipients or taste-masking compounds [10,15].…”

Section: Neonatal Clinical Pharmacy: How To Cope With Neonatal Formulmentioning

confidence: 99%

Neonates and medicines: a roadmap to further improve neonatal pharmaceutical care

Allegaert

Sherwin

2016

Eur J Pediatr

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The treatment of newborns with safe and effective medicines is of critical importance for their outcome and subsequent quality of life. Despite this, it is still a common practice to prescribe medicines to neonates outside the label, extrapolating from dosing regimens and indications validated in older populations and based on non-neonatal pathophysiology. In a recent meta-analysis (2015) evaluating 829 (1994-2012) studies on prescribing practices in pediatric hospital care, off-label and unlicensed medicines prescriptions ranged from 12 to 71 % and 0.2 to 48 %. These authors hereby reconfirmed that (pre)term neonates were still most commonly exposed to off-label and unlicensed medicines [12].The federal US legislation and similar European initiatives have resulted in a relevant increase in pharmacological studies in children, with a subsequent significant increase in label changes. Unfortunately, too few included drug label changes specific to neonates. To further illustrate this, there were 406 pediatric label changes (Food and Drug Administration, 1997-2010), but only 23 drugs resulted in 11 labeled indications (e.g., linezolid, rocuronium, remifentanil, sevoflurane, stavudine, nevirapine) for neonates. The absence of label change was most commonly because of unproven efficacy, despite the fact that these compounds (e.g., paracetamol, caspofungin, valganciclovir) are likely relevant for neonates [14]. This may largely reflect the difficulties to proof efficacy due to heterogeneity in patients, variability in outcome variables, and uncertainty on biomarkers, in addition to demonstrating safety (risk of adverse drug events) in neonates. Despite the significant improvements in the knowledge on pharmacotherapy in older children, neonates still remain therapeutic orphans [2,14].In this issue of the journal, Campino et al. report on the rate of errors (calculation or accuracy) in intravenous medicine preparations when performed either bedside in 10 Spanish neonatal intensive care units (NICUs) or in hospital pharmacy (HP) services. The study group hereby evaluated the impact of a structured intervention (protocol standardization, education) on the number of errors and documented significant improvements in both calculation errors (1.35 to 0 %) and accuracy (54.7 and 38.3 % to 38.3 and 14.6 % in NICU and HP, respectively) [6]. This intervention paper follows on a previous paper which described a pre-intervention phase [5] and illustrates the potential impact of preventive strategies on the extent of drug errors.Development of a roadmap to improve neonatal pharmaceutical care should aim to improve the knowledge on clinical pharmacology, clinical pharmacy, and approaches to improve the knowledge and use of neonatal pharmacovigilance initiatives [1]. Another keystone component of such a roadmap should focus on neonatal drug development, i.e., drug development driven by neonatal pathophysiology (Fig. 1).

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“…This includes considering the impact on clinical routines of preparing medicines and collecting data. Units differ markedly with respect to how medicines are administered (syringe driver, filtration policies, approach to infusing multiple medicines, dead spaces in complex infusion setups) and this can affect the implementation of the study [19]. Failure to appreciate the details of care can delay site opening by several months.…”

Section: Investigatormentioning

confidence: 99%

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

Turner

2015

Brit J Clinical Pharma

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In the past, there has been a perception that ethical and practical problems limit the opportunities for research in neonates. This perception is no longer appropriate. It is now clear that research about the medicines used in neonates is an ethical requirement. It is possible to conduct high quality research in neonates if the research team adapt to the characteristics of this population. Good practice involves respecting the specific needs of newborn babies and their families by adopting relevant approaches to study design, recruitment, pharmacokinetic studies and safety assessment. Neonatal units have a unique culture that requires careful development in a research setting. Clinical investigators need to recognize the clinical and ethical imperative to conduct rigorous research. Industry needs to engage with neonatal networks early in the process of drug development, preferably before contacting regulatory agencies. Follow-up over 3-5 years is essential for the evaluation of medicines in neonates and explicit funding for this is required for the assessment of the benefit and risk of treatments given to sick newborn babies. The views of parents must be central to the development of studies and the research agenda. Ethical and practical problems are no longer barriers to research in neonates. The current challenges are to disseminate good practice and maximize capacity in order to meet the need for research among newborn babies.

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Intravenous drug delivery in neonates: lessons learnt

Cited by 48 publications

References 45 publications

What Should We Do about Low Blood Pressure in Preterm Infants

What Should We Do about Low Blood Pressure in Preterm Infants

Neonates and medicines: a roadmap to further improve neonatal pharmaceutical care

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

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