scholarly journals Randomised controlled pilot trial comparing low dose and very low- dose microdrop administration of phenylephrine and cyclopentolate for retinopathy of prematurity eye examinations in neonates

2020 ◽  
pp. archdischild-2019-318733
Author(s):  
Lisa Jean Kremer ◽  
Roland Broadbent ◽  
Natalie Medlicott ◽  
Mary Jane Sime ◽  
Frances McCaffrey ◽  
...  
Keyword(s):  
New Zealand ◽  
Adverse Effects ◽  
Retinopathy Of Prematurity ◽  
Neonatal Intensive Care ◽  
Low Dose ◽  
Pilot Trial ◽  
Safety Data ◽  
List Type ◽  
Registration Number ◽  
Randomised Controlled

AimsTo determine ifVery low dose mydriatic eye microdrop regimen sufficiently dilates the pupil (above 4.1 mm) compared with the currently used low dose mydriatic eye microdrop regimen.Cardiovascular, gastrointestinal and respiratory adverse effects occur following eye drop instillation.MethodsSeventeen premature infants were recruited into this prospective, randomised controlled pilot trial in January 2017 to November 2018. Data were collected from the single-centre Neonatal Intensive Care Unit, Dunedin Hospital, New Zealand. The inclusion criteria were birth weight less than 1500 g or gestational age less than 31 weeks, or any premature infant requiring red reflex testing. Infants were randomised to receive either phenylephrine 1% or 0.5% and cyclopentolate 0.2% or 0.1%, 1 microdrop in both eyes. Efficacy outcome measures were pupil size at retinopathy of prematurity eye examination (ROPEE) and ophthalmologist rating of ease of screen.ResultsAll participants had sufficient pupillary dilation for a successful ROPEE. Ophthalmologists rated the ROPEE as easy for 90% of all examinations. Pupil dilation measurements at the time of examination, mean±SD, 4.8±0.2 (95% CI 4.5 to 5.2) mm for treatment A and 5±0.2 (95%CI 4.6 to 5.4) mm for treatment B (p=0.61). There were no statistically significant differences between the groups for safety data.ConclusionsVery low dose microdrop administration of phenylephrine and cyclopentolate appears to be effective at sufficiently dilating the neonatal pupil for ROPEEs. Low dose and very low dose microdrop mydriatic regimens may also reduce the risk of unwanted adverse effects associated with these medicines.Trial registration numberAustralian New Zealand Clinical Trials Registry (reference ACTRN12616001266459p).

A Survey of Neonatal Nurses on Mydriatic Regimens Used in Neonatal Retinopathy of Prematurity Eye Examinations

2021 ◽  
Author(s):  
Lisa Kremer ◽  
David Reith ◽  
Natalie J. Medlicott ◽  
Mary J. Sime ◽  
Liza Edmonds ◽  
...  
Keyword(s):  
New Zealand ◽  
Adverse Effects ◽  
Retinopathy Of Prematurity ◽  
Adverse Drug Events ◽  
Preterm Neonates ◽  
Eye Drops ◽  
Cross Sectional Survey ◽  
Cross Sectional ◽  
Aotearoa New Zealand ◽  
Adult Dose

Objective This study was aimed to determine mydriatic regimen(s) used in neonatal units in Aotearoa New Zealand (NZ) and Australia and to estimate the frequency of adverse drug events following mydriatic administration in preterm neonates. Study Design A cross-sectional survey was sent to neonatal nursing staff listed in the Australian and New Zealand Neonatal Network contact list. Participants were asked to state what mydriatic regimen they use, and to estimate the frequency of adverse drug events when eye drops were administered for retinopathy of prematurity eye examinations (ROPEE). Results Thirteen different mydriatic regimens were identified; phenylephrine 2.5% and cyclopentolate 0.5% (1 standard drop of each) was the most commonly used regimen. Two of the regimens exceeded adult doses and five regimens included a mydriatic that is equivalent to an adult dose. Following mydriatic instillation, the three most common adverse effects were apnea, tachycardia, and periorbital pallor. Conclusion Low-concentration single-microdrop regimens are currently in use and resulting in successful ROPEE, yet doses exceeding adult doses are in use throughout Aotearoa NZ and Australian units. We know from this dataset that neonates are experiencing unwanted and potentially preventable, adverse effects associated with mydriatics, and every effort should be made to minimize this risk. Key Points

scholarly journals Safety and efficacy of subcutaneous tocilizumab in systemic sclerosis: results from the open-label period of a phase II randomised controlled trial (faSScinate)

2017 ◽  
Vol 77 (2) ◽  
pp. 212-220 ◽  
Author(s):  
Dinesh Khanna ◽  
Christopher P Denton ◽  
Celia J F Lin ◽  
Jacob M van Laar ◽  
Tracy M Frech ◽  
...  
Keyword(s):  
Systemic Sclerosis ◽  
Phase Ii ◽  
Controlled Trial ◽  
Safety Data ◽  
Open Label ◽  
Double Blind ◽  
Skin Score ◽  
Open Label Extension ◽  
Registration Number ◽  
Randomised Controlled

ObjectivesAssess the efficacy and safety of tocilizumab in patients with systemic sclerosis (SSc) in a phase II study.MethodsPatients with SSc were treated for 48 weeks in an open-label extension phase of the faSScinate study with weekly 162 mg subcutaneous tocilizumab. Exploratory end points included modified Rodnan Skin Score (mRSS) and per cent predicted forced vital capacity (%pFVC) through week 96.ResultsOverall, 24/44 (55%) placebo-tocilizumab and 27/43 (63%) continuous-tocilizumab patients completed week 96. Observed mean (SD (95% CI)) change from baseline in mRSS was –3.1 (6.3 (–5.4 to –0.9)) for placebo and –5.6 (9.1 (–8.9 to–2.4)) for tocilizumab at week 48 and –9.4 (5.6 (–8.9 to –2.4)) for placebo-tocilizumab and –9.1 (8.7 (–12.5 to –5.6)) for continuous-tocilizumab at week 96. Of patients who completed week 96, any decline in %pFVC was observed for 10/24 (42% (95% CI 22% to 63%)) placebo-tocilizumab and 12/26 (46% (95% CI 27% to 67%)) continuous-tocilizumab patients in the open-label period; no patients had >10% absolute decline in %pFVC. Serious infection rates/100 patient-years (95% CI) were 10.9 (3.0 to 27.9) with placebo and 34.8 (18.0 to 60.8) with tocilizumab during the double-blind period by week 48 and 19.6 (7.2 to 42.7) with placebo-tocilizumab and 0.0 (0.0 to 12.2) with continuous-tocilizumab during the open-label period.ConclusionsSkin score improvement and FVC stabilisation in the double-blind period were observed in placebo-treated patients who transitioned to tocilizumab and were maintained in the open-label period. Safety data indicated increased serious infections in patients with SSc but no new safety signals with tocilizumab.Trial registration numberNCT01532869; Results.

Ready Player Two: A randomised controlled pilot trial investigating the feasibility of using games to improve healthy lifestyle knowledge in youth (9-16 years) at risk for type two diabetes. (Preprint)

2021 ◽  
Author(s):  
Ralph Maddison ◽  
Nilufar Baghaei ◽  
Amanda Jane Calder ◽  
Rinki Murphy ◽  
Varsha Parag ◽  
...  
Keyword(s):  
At Risk ◽  
New Zealand ◽  
Healthy Lifestyle ◽  
Pilot Trial ◽  
Extended Period ◽  
Trial Registration ◽  
Diabetes Knowledge ◽  
Game Play ◽  
Health Research Council ◽  
Randomised Controlled

UNSTRUCTURED Objective: To determine the comparative use and knowledge effects of two prototype serious games for health on healthy lifestyle knowledge in youth aged 9-16 years at risk for type 2 diabetes (T2D). Methods: A three-arm parallel randomized controlled pilot trial was undertaken to assess use of the game, and the effect of the game on healthy lifestyle and T2D diabetes knowledge. Participants were allocated to ‘Diabetic Jumper’ (n=7), ‘Ari and Friends’ (n=8), or a control game (n=8). All participants completed healthy lifestyle and T2D knowledge questionnaires at baseline, immediately after game play, and four weeks after game play. Game attitudes and preferences were also assessed. The primary outcome was the use of the game, specifically, the number of minutes played over four weeks. Results: There were no statistical differences in healthy lifestyle knowledge or diabetes knowledge over time or across games. Only one participant accessed the game for an extended period, playing the game for a total of 33 min over 4 weeks. Conclusion: Two prototype serious were unsuccessful at sustaining long-term play outside a clinic environment. However, the potential for these games to be used as stimulus to engage young people with healthy lifestyle and diabetes knowledge in a clinic setting should be further explored. Suggested improvements for future studies are discussed. Trial Registration: Australia New Zealand Clinical Trials Registry, ACTRN12619000380190. Registered 11 March 2019, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377123 Funding: The trial was funded by a Health Research Council of New Zealand Feasibility grant.

scholarly journals The perioperative administration of dexamethasone and infection (PADDI) trial protocol: rationale and design of a pragmatic multicentre non-inferiority study

BMJ Open ◽  
2019 ◽  
Vol 9 (9) ◽  
pp. e030402 ◽  
Author(s):  
Tomás B Corcoran ◽  
Paul S Myles ◽  
Andrew B Forbes ◽  
Ed O'Loughlin ◽  
Kate Leslie ◽  
...  
Keyword(s):  
New Zealand ◽  
Postoperative Nausea And Vomiting ◽  
Ethics Committees ◽  
Immunosuppressive Agent ◽  
Research Network ◽  
Major Surgery ◽  
Diabetes Status ◽  
Registration Number ◽  
Randomised Controlled ◽  
Patient Enrolment

IntroductionThe intraoperative administration of dexamethasone for prophylaxis against postoperative nausea and vomiting is a common and recommended practice. The safety of the administration of this immunosuppressive agent at a time of significant immunological disruption has not been rigorously evaluated in terms of infective complications.Methods/analysisThis is a pragmatic, multicentre, randomised, controlled, non-inferiority trial. A total of 8880 patients undergoing elective major surgery will be enrolled. Participants will be randomly allocated to receive either dexamethasone 8 mg or placebo intravenously following the induction of anaesthesia in a 1:1 ratio, stratified by centre and diabetes status. Patient enrolment into the trial is ongoing. The primary outcome is surgical site infection at 30 days following surgery, defined according to the Centre for Disease Control criteria.Ethics/disseminationThe PADDI trial has been approved by the ethics committees of over 45 participating sites in Australia, New Zealand, Hong Kong, South Africa and the Netherlands. The trial has been endorsed by the Australia and New Zealand College of Anaesthetists Clinical Trials Network and the Australian Society for Infectious Diseases Clinical Research Network. Participant recruitment began in March 2016 and is expected to be complete in mid-2019. Publication of the results of the PADDI trial is anticipated to occur in early 2020.Trial registration numberACTRN12614001226695.

scholarly journals Efficacy of Low-Dose Epinephrine Continuous Infusion in Neonatal Intensive Care Unit Patients

2021 ◽  
Vol 26 (1) ◽  
pp. 51-55
Author(s):  
Gloria Lee ◽  
Jeffrey R. Kaiser ◽  
Brady S. Moffett ◽  
Emily Rodman ◽  
Cynthia Toy ◽  
...  
Keyword(s):  
Intensive Care Unit ◽  
Intensive Care ◽  
Adverse Effects ◽  
Neonatal Intensive Care Unit ◽  
Continuous Infusion ◽  
Neonatal Intensive Care ◽  
Low Dose ◽  
Epinephrine Infusion ◽  
Starting Dose ◽  
Few Data

OBJECTIVES Although epinephrine is used in the neonatal intensive care unit, few data exist on efficacy of doses <0.05 mcg/kg/min. This study evaluates the efficacy and safety of low-dose epinephrine continuous infusion at doses <0.05 mcg/kg/min in infants. METHODS Single-center, retrospective review of hypotensive infants from 2011–2018. Charts were reviewed for initial and maximum epinephrine doses, additional vasoactive agents, short-term efficacy, and adverse effects. The primary outcome was percentage of patients initiated on low-dose epinephrine whose dose did not require titration to ≥0.05 mcg/kg/min. RESULTS A total of 115 patients met study criteria with 131 distinct occurrences of low-dose epinephrine initiation. Most patients were unresponsive to other vasopressors at the time of epinephrine initiation. The median (IQR) starting dose of low-dose epinephrine was 0.01 (0.01–0.04) mcg/kg/min and median (IQR) maximum dose was 0.04 (0.02–0.08) mcg/kg/min. Fifty-five percent were responders. Patients in this cohort demonstrated significant improvement of blood pressure and urine output (p < 0.001) without adverse effects. CONCLUSIONS Low-dose epinephrine infusion may be considered as an alternative treatment to standard starting doses in hypotensive neonatal intensive care unit patients.

Premedication for Endotracheal Intubation in the Neonate

2018 ◽  
Vol 37 (4) ◽  
pp. 238-247
Author(s):  
Christopher McPherson
Keyword(s):  
Adverse Effects ◽  
Endotracheal Intubation ◽  
Muscle Relaxant ◽  
Neonatal Intensive Care ◽  
Safety Data ◽  
Pharmacokinetic Profile ◽  
Preterm Neonates ◽  
Pharmacokinetic Data ◽  
Common Procedure ◽  
Duration Of Action

Endotracheal intubation, a common procedure in neonatal intensive care, results in distress and disturbs physiologic homeostasis in the newborn. Analgesics, sedatives, vagolytics, and/or muscle relaxants have the potential to blunt these adverse effects, reduce the duration of the procedure, and minimize the number of attempts necessary to intubate the neonate. The medical care team must understand efficacy, safety, and pharmacokinetic data for individual medications to select the optimal cocktail for each clinical situation. Although many units utilize morphine for analgesia, remifentanil has a superior pharmacokinetic profile and efficacy data. Because of hypotensive effects in preterm neonates, sedation with midazolam should be restricted to near-term and term neonates. A vagolytic, generally atropine, blunts bradycardia induced by vagal stimulation. A muscle relaxant improves procedural success when utilized by experienced practitioners; succinylcholine has an optimal pharmacokinetic profile, but potentially concerning adverse effects; rocuronium may be the agent of choice based on more robust safety data despite a relatively prolonged duration of action. In the absence of an absolute contraindication, neonates should receive analgesia with consideration of sedation, a vagolytic, and a muscle relaxant before endotracheal intubation. Neonatal units must develop protocols for premedication and optimize logistics to ensure safe and timely administration of appropriate agents.

scholarly journals Bevacizumab in Retinopathy of Prematurity : Concerns and adverse effects

2020 ◽  
Vol 12 (2) ◽  
pp. 298-307
Author(s):  
Anuj Sharma ◽  
Adheesh Shetty ◽  
Y.C. Venu Gopal Reddy
Keyword(s):  
Developing Countries ◽  
Adverse Effects ◽  
Retinopathy Of Prematurity ◽  
Controlled Trial ◽  
Case Series ◽  
Intravitreal Bevacizumab ◽  
Vital Role ◽  
Age Group ◽  
Paediatric Age ◽  
Randomised Controlled

Retinopathy of prematurity (ROP) ranks as one of the leading causes of blindness in the paediatric age group, the incidence of which is increasing in developing countries as the economy strengthens and healthcare practices improve. As a vasoproliferative disorder affecting premature neonates VEGF is said to play a vital role in the pathogenesis of ROP. Evidence of the efficacy of anti-VEGF agents in treatment of ROP have been seen in literature since early 2007 with most published reports being either case studies or small case series. The only randomised controlled trial in this regard was the BEAT-ROP study which was published in 2011. However, even in that study the adverse effects of Bevacizumab were not analysed. This review aims to discuss the complications prior to the blanket administration of intravitreal bevacizumab in the management of ROP.

Interactive multiple area spectrum integration (MASI)

1994 ◽  
Vol 52 ◽  
pp. 942-943
Author(s):  
John A. Hunt ◽  
Richard D. Leapman ◽  
David B. Williams
Keyword(s):  
Image Processing ◽  
Low Dose ◽  
Routine Analysis ◽  
Reference Image ◽  
Area Spectrum ◽  
List Type ◽  
Type Number ◽  
Image Processor ◽  
X Ray ◽  
Scanning Path

Interactive MASI involves controlling the raster of a STEM or SEM probe to areas predefined byan integration mask which is formed by image processing, drawing or selecting regions manually. EELS, x-ray, or other spectra are then acquired while the probe is scanning over the areas defined by the integration mask. The technique has several advantages: (1) Low-dose spectra can be acquired by averaging the dose over a great many similar features. (2) MASI can eliminate the risks of spatial under- or over-sampling of multiple, complicated, and irregularly shaped objects. (3) MASI is an extremely rapid and convenient way to record spectra for routine analysis. The technique is performed as follows:Acquire reference imageOptionally blank beam for beam-sensitive specimensUse image processor to select integration mask from reference imageCalculate scanning path for probeUnblank probe (if blanked)Correct for specimen drift since reference image acquisition

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