scholarly journals Breastmilk as a Multisensory Intervention for Relieving Pain during Newborn Screening Procedures: A Randomized Control Trial

2021 ◽  
Vol 18 (24) ◽  
pp. 13023
Author(s):  
Hsiang-Yun Lan ◽  
Luke Yang ◽  
Chiao-Hsuan Lin ◽  
Kao-Hsian Hsieh ◽  
Yue-Cune Chang ◽  
...  
Keyword(s):  
Newborn Screening ◽  
Controlled Trial ◽  
Phase 1 ◽  
Routine Care ◽  
Pain Scale ◽  
Baseline Phase ◽  
Video Recordings ◽  
Treatment Conditions ◽  
Relieve Pain ◽  
Infant Pain

The study aim was to explore the effects of multisensory breastmilk interventions on short-term pain of infants during newborn screening. This is a randomized controlled trial. A total of 120 newborns were recruited and assigned by randomization to one of three treatment conditions: Condition 1 = routine care (gentle touch + verbal comfort); Condition 2 = breastmilk odor + routine care; or Condition 3 = breastmilk odor + taste + routine care. Pain was scored with the Neonatal Infant Pain Scale (NIPS). Data were collected from video recordings at 1 min intervals over the 11 phases of heel sticks: phase 1, 5 min before heel stick without stimuli (baseline); phase 2 to phase 6 (during heel stick); and phase 7 to phase 11 (recovery). Generalized estimating equations compared differences in pain scores for newborns over phases among the three conditions. Compared with the routine care, provision of the odor and taste of breastmilk reduce NIPS scores during heel sticks (B = −4.36, SE = 0.45, p < 0.001 [phase6]), and during recovery (B = −3.29, SE = 0.42, p < 0.001 [phase7]). Our findings provide new data, which supports the use of multisensory interventions that include breastmilk odor and taste in combination with gentle touch and verbal comfort to relieve pain in infants undergoing newborn screening.

scholarly journals Efficacy of Oral Glucose in Reducing Behavioural Responses to a Noxious Stimulus in Healthy Term Neonates

2021 ◽  
Author(s):  
Amal Naous ◽  
Hassan El Khatib ◽  
Bilal Azakir ◽  
Farah Hajjar ◽  
Hanan Baltaji ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Pain Scale ◽  
Full Term ◽  
Oral Glucose ◽  
Pain Response ◽  
Double Blind ◽  
Term Neonates ◽  
Neonatal Pain ◽  
Infant Pain ◽  
Heel Prick

Abstract The aim of the study is to evaluate the effect of orally administered glucose, at concentrations of 5% and 30%, on the nociceptive behavioural pain response among full-term neonates who underwent the heel puncture technique. This is a prospective, randomized, double-blind, placebo-controlled trial which was registered at clinicaltrials.gov under the number Makassed General Hospital Protocol Record 1722017 in July 2017. This trial studied the effect of glucose solution on pain relief in 244 full-term healthy neonates who underwent a heel prick procedure. Neonatal pain was assessed using the Neonatal Infant Pain Scale (NIPS) and the duration of cry. The results showed that neonates receiving 30% glucose during the procedure had significantly the lowest mean NIPS (mean=4.89) compared to placebo and 5% group (mean=5.8 and 5.2 respectively) (p=0.03). Neonates in the glucose groups of both 5% (65.9%) and 30% (70.4%) scored significantly as having less pain compared with the placebo group (86.4%) (p=0.01). The neonates in the 30% glucose group cried less and had a significantly shorter crying duration (mean: 39.9 seconds) than in the 5% and placebo groups (p=0.04). Conclusion: 30% glucose and, to a lesser extent, 5% glucose were effective in reducing the behavioral pain response from heel prick procedures in term neonates.

scholarly journals A Randomized Controlled Trial of Assisted Intention Monitoring for the Rehabilitation of Executive Impairments Following Acquired Brain Injury

2016 ◽  
Vol 31 (4) ◽  
pp. 323-333 ◽  
Author(s):  
Fergus Gracey ◽  
Jessica E. Fish ◽  
Eve Greenfield ◽  
Andrew Bateman ◽  
Donna Malley ◽  
...  
Keyword(s):  
Brain Injury ◽  
Controlled Trial ◽  
Phase 1 ◽  
Memory Task ◽  
Acquired Brain Injury ◽  
Text Messages ◽  
Mean Difference ◽  
Medium Effect ◽  
Double Blind ◽  
Baseline Phase

Background. Acquired brain injury (ABI) can impair executive function, impeding planning and attainment of intentions. Research shows promise for some goal-management rehabilitation interventions. However, evidence that alerts assist monitoring and completion of day-to-day intentions is limited. Objective. To examine the efficacy of brief goal-directed rehabilitation paired with periodic SMS text messages designed to enhance executive monitoring of intentions (assisted intention monitoring [AIM]). Methods. A randomized, double-blind, controlled trial was conducted. Following a baseline phase, 74 people with ABI and executive problems were randomized to receive AIM or control (information and games) for 3 weeks (phase 1) before crossing over to either AIM or no intervention (phase 2). The primary outcome was change in composite score of proportion of daily intentions achieved. A total of 59 people (71% male; 46% traumatic brain injury) completed all study phases. Results. Per protocol crossover analysis found a significant benefit of AIM for all intentions [ F(1, 56) = 4.28; P = .04; f = 0.28; 3.7% mean difference; 95% CI = 0.1%-7.4%] and all intentions excluding a proxy prospective memory task [ F(1, 55) = 4.79; P = .033; f = 0.28, medium effect size; 3% mean difference; 95% CI = 0.3%-5.6%] in the absence of significant changes on tests of executive functioning. Intention-to-treat analyses, comparing AIM against control at the end of phase 1 revealed no statistically significant differences in the attainment of intentions. Conclusion. Combining brief executive rehabilitation with alerts may be effective for some in improving achievement of daily intentions, but further evaluation of clinical effectiveness and mechanisms is required.

scholarly journals Implementation of C-reactive protein point of care testing to improve antibiotic targeting in respiratory illness in Vietnamese primary care (ICAT): a study protocol for a cluster randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (12) ◽  
pp. e040977
Author(s):  
Nga Thi Thuy Do ◽  
Rachel Claire Greer ◽  
Yoel Lubell ◽  
Sabine Dittrich ◽  
Maida Vandendorpe ◽  
...  
Keyword(s):  
Primary Care ◽  
Antibiotic Prescription ◽  
Point Of Care ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Antibiotic Use ◽  
Routine Care ◽  
C Reactive Protein ◽  
Reactive Protein ◽  
Randomised Controlled

IntroductionC-reactive protein (CRP), a biomarker of infection, has been used widely in high-income settings to guide antibiotic treatment in patients presenting with respiratory illnesses in primary care. Recent trials in low- and middle-income countries showed that CRP testing could safely reduce antibiotic use in patients with non-severe acute respiratory infections (ARIs) and fever in primary care. The studies, however, were conducted in a research-oriented context, with research staff closely monitoring healthcare behaviour thus potentially influencing healthcare workers’ prescribing practices. For policy-makers to consider wide-scale roll-out, a pragmatic implementation study of the impact of CRP point of care (POC) testing in routine care is needed.Methods and analysisA pragmatic, cluster-randomised controlled trial, with two study arms, consisting of 24 commune health centres (CHC) in the intervention arm (provision of CRP tests with additional healthcare worker guidance) and 24 facilities acting as controls (routine care). Comparison between the treatment arms will be through logistic regression, with the treatment assignment as a fixed effect, and the CHC as a random effect. With 48 clusters, an average of 10 consultations per facility per week will result in approximately 520 over 1 year, and 24 960 in total (12 480 per arm). We will be able to detect a reduction of 12% to 23% or more in immediate antibiotic prescription as a result of the CRP POC intervention. The primary endpoint is the proportion of patient consultations for ARI resulting in immediate antibiotic prescription. Secondary endpoints include the proportion of all patients receiving an antibiotic prescription regardless of ARI diagnosis, frequency of re-consultation, subsequent antibiotic use when antibiotics are not prescribed, referral and hospitalisation.Ethics and disseminationThe study protocol was approved by the Oxford University Tropical Research Ethics Committee (OxTREC, Reference: 53–18), and the ethical committee of the National Hospital for Tropical Diseases in Vietnam (Reference:07/HDDD-NDTW/2019). Results from this study will be disseminated via meetings with stakeholders, conferences and publications in peer-reviewed journals. Authorship and reporting of this work will follow international guidelines.Trial registration detailsNCT03855215; Pre-results.

scholarly journals 1288. Phase 1 First-in-Human Single- and Multiple-Ascending Dose Trial Demonstrates Pharmacokinetics (PK) and Tolerability of SPR720, an Oral DNA GyrB Inhibitor for Mycobacterial Infections

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S659-S659
Author(s):  
Angela Talley ◽  
Archie Thurston ◽  
Grayson Moore ◽  
Myriah M Satterfield ◽  
Erika L Manyak ◽  
...  
Keyword(s):  
Adverse Events ◽  
Healthy Volunteers ◽  
Controlled Trial ◽  
Phase 1 ◽  
Safety Data ◽  
Elderly Subjects ◽  
Independent Contractor ◽  
Serious Adverse Events ◽  
Healthy Elderly ◽  
Dose Proportional

Abstract Background SPR720 (phosphate pro-drug of SPR719) is a novel aminobenzimidazole bacterial DNA gyrase (GyrB) inhibitor in development for non-tuberculous mycobacterial lung disease (NTM-LD) and pulmonary tuberculosis. SPR719 has broad-spectrum activity versus clinically relevant mycobacteria in vitro and in murine and hollow fiber (HF) infection models. In this first-in-human single ascending dose (SAD) /multiple ascending dose (MAD) study, the safety, tolerability and pharmacokinetics (PK) of SPR720/SPR719 were evaluated in healthy volunteers. Methods This was a Phase 1 randomized, double-blind, placebo-controlled trial with 7 SAD cohorts (including a food effect cohort) and 5 MAD cohorts. Healthy volunteers (n=8/cohort, 3:1 randomization) received SPR720 or placebo in single oral doses of ranging from 100 mg to 2000 mg or repeat total daily doses ranging from 500 mg to 1500 mg for 7 or 14 days. Safety monitoring and PK sampling occurred throughout the trial. Plasma and urine concentrations of SPR720/SPR719 were measured by validated LC-MS/MS methods. PK parameters were calculated using non-compartmental analysis. Results A total of 96 subjects (including 8 healthy elderly subjects, age ≥ 65 years) were randomized and received study drug. SPR720 was well-tolerated at daily doses up to 1000 mg for up to 14 days. Across SAD/MAD cohorts, the most common adverse events were gastrointestinal (nausea, vomiting and diarrhea) and headache, all of mild or moderate severity and dose dependent. No serious adverse events were reported. Across SAD cohorts, a dose proportional and greater-than-dose proportional increase in SPR719 plasma Cmax and AUC0-24, respectively were observed. SPR720 was rapidly absorbed with a mean SPR719 t1/2 of 2.9-4.5 h. Dosing with food decreased SPR719 plasma AUC by ~20%. No clinically meaningful effect of age on plasma AUC was observed. In the MAD cohorts, SPR719 plasma exposure declined approximately 40% between Day 1 and Day 7, suggesting induction of an elimination pathway. However, plasma AUC0-24 was similar at Days 7 and 14. Conclusion Together with HF pharmacodynamic data, human PK and safety data for SPR720 suggest that predicted therapeutic exposures can be attained with a well-tolerated once-daily dose. Further evaluation in a Phase 2 NTM-LD trial is planned. Disclosures Angela Talley, MD, Spero Therapeutics (Employee, Shareholder) Archie Thurston, Jr., PhD, Spero Therapeutics (Consultant) Grayson Moore, BA, RN, Spero Therapeutics, Inc. (Shareholder, Independent Contractor) Vipul Kumar, PhD, Spero Therapeutics (Employee, Shareholder) Suzanne Stokes, PhD, Spero Therapeutics (Employee, Shareholder) Aaron Dane, MSc, Spero theraputics (Consultant) David Melnick, MD, Spero Therapeutics (Employee)Spero Therapeutics (Employee)

scholarly journals Nutrigenetics-based intervention approach for adults with non-alcoholic fatty liver disease (NAFLD): study protocol for a randomised controlled feasibility trial

BMJ Open ◽  
2021 ◽  
Vol 11 (4) ◽  
pp. e045922
Author(s):  
Laura Haigh ◽  
Stuart McPherson ◽  
John C Mathers ◽  
Quentin M Anstee
Keyword(s):  
Liver Disease ◽  
Fatty Liver ◽  
Fatty Liver Disease ◽  
Controlled Trial ◽  
Phase 1 ◽  
Feasibility Trial ◽  
Alcoholic Fatty Liver ◽  
Intervention Protocol ◽  
Randomised Controlled ◽  
Alcoholic Fatty Liver Disease

IntroductionLifestyle interventions targeting weight loss and improved dietary patterns are the recommended treatment for non-alcoholic fatty liver disease (NAFLD). However, the effectiveness of current established diet therapies is suboptimal. The patatin‐like phospholipase domain containing 3 (PNPLA3) gene modifies disease outcome and hepatic lipid handling, but the role of PNPLA3 variants in modulating responsiveness to different diet therapies is unknown.Methods and analysisThis project aims to assess the feasibility of conducting a genotype-driven randomised controlled trial (RCT) investigating the differential response to a Mediterranean diet (MD) intervention of NAFLD patients according to genotype for the rs738409 (I148M) variant of PNPLA3. A single-centre randomised controlled feasibility trial will be undertaken. We will recruit 60 adults with NAFLD from a tertiary hepatology centre in England. In a cross-over design, participants will undertake Diet 1 (MD) and Diet 2 (control) for 4 weeks, in random order (1:1 allocation), separated by a 4 weeks washout period. Participants will complete one-to-one diet and lifestyle consultations at baseline, end of diet phase 1, end of washout and end of diet phase 2. Participants will be advised to maintain baseline levels of physical activity and body weight. The primary outcome is the acceptability and feasibility of the intervention protocol. Secondary outcomes include exploratory assessment of liver fibrosis biomarkers and lipid biomarkers.Ethics and disseminationEthical approval was granted by East of Scotland Research Ethics Service REC 1 (19/ES/0112). Results will be disseminated through peer-reviewed journals and presented at local, national and international meetings and conferences. The findings of this trial will lay the foundation for a future definitive RCT by informing trial design and optimising the intervention diets, instruments and procedures.Trial registration numberISRCTN93410321.

scholarly journals Effect of mesenchymal stromal cell infusions on lung function in COPD patients with high CRP levels

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Daniel J. Weiss ◽  
Karen Segal ◽  
Richard Casaburi ◽  
Jack Hayes ◽  
Donald Tashkin
Keyword(s):  
Lung Function ◽  
Time Course ◽  
Inflammatory Marker ◽  
Controlled Trial ◽  
Phase 1 ◽  
Forced Expiratory Volume ◽  
Allogeneic Mscs ◽  
Copd Exacerbations ◽  
Copd Patients ◽  
Patient Reported

Abstract Background We previously reported a Phase 1/2 randomized placebo-controlled trial of systemic administration of bone marrow-derived allogeneic MSCs (remestemcel-L) in COPD. While safety profile was good, no functional efficacy was observed. However, in view of growing recognition of effects of inflammatory environments on MSC actions we conducted a post-hoc analysis with stratification by baseline levels of a circulating inflammatory marker, C-reactive protein (CRP) to determine the effects of MSC administration in COPD patients with varying circulating CRP levels. Methods Time course of lung function, exercise performance, patient reported responses, and exacerbation frequency following four monthly infusions of remestemcel-L vs. placebo were re-assessed in subgroups based on baseline circulating CRP levels. Results In COPD patients with baseline CRP ≥ 4 mg/L, compared to COPD patients receiving placebo (N = 17), those treated with remestemcel-L (N = 12), demonstrated significant improvements from baseline in forced expiratory volume in one second, forced vital capacity, and six minute walk distance at 120 days with treatment differences evident as early as 10 days after the first infusion. Significant although smaller benefits were also detected in those with CRP levels ≥ 2 or ≥ 3 mg/L. These improvements persisted variably over the 2-year observational period. No significant benefits were observed in patient reported responses or number of COPD exacerbations between treatment groups. Conclusion In an inflammatory environment, defined by elevated circulating CRP, remestemcel-L administration yielded at least transient meaningful pulmonary and functional improvements. These findings warrant further investigation of potential MSC-based therapies in COPD and other inflammatory pulmonary diseases. Trial registration: Clinicaltrials.gov NCT00683722.

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