Tocopherol Efficacy and Safety for Preventing Retinopathy of Prematurity: A Randomized, Controlled, Double-Masked Trial

PEDIATRICS ◽  
1987 ◽  
Vol 79 (4) ◽  
pp. 489-500 ◽  
Author(s):  
Dale L. Phelps ◽  
Arthur L. Rosenbaum ◽  
Sherwin J. lsenberg ◽  
Rosemary D. Leake ◽  
Frederick J. Dorey
Keyword(s):  
Premature Infants ◽  
Retinopathy Of Prematurity ◽  
Plasma Levels ◽  
Late Onset ◽  
Retinal Hemorrhage ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
Late Onset Sepsis ◽  
Prospective Monitoring

To test the efficacy and safety of vitamin E in preventing retinopathy of prematurity, 287 infants with birth weights of less than 1.5 kg or gestational ages of less than 33 weeks were enrolled within 24 hours of birth in a randomized, double-masked trial of IV, followed by oral, placebo v tocopherol (adjusted to plasma levels of 3 to 3.5 mg/dL). In the 196 infants completing ophthalmic follow-up, tocopherol did not prevent retinopathy of prematurity of any stage (28% placebo treated v 26% tocopherol treated) or moderately severe retinopathy of prematurity (8% placebo treated v 11% tocopherol treated). Cicatricial sequelae were not significantly different (1/97 placebo treated v 3/99 tocopherol treated), with one placebo-treated infant and one tocopherol-treated infant having retinal detachments. Among all 232 infants examined, those treated with tocopherol had more retinal hemorrhage than placebo-treated infants (8/121 placebo treated v 16/111 tocopherol treated), and retinal hemorrhage correlated positively (P < .01) with plasma levels of tocopherol after the first 2 weeks of age. Prospective monitoring of morbidity including late-onset sepsis, necrotizing enterocolitis, etc revealed no differences between groups except that grades 3 and 4 intraventricular hemorrhage occurred more frequently in infants weighing less than 1 kg at birth who had received tocopherol (14/42, 33%) v those who had received placebo (4/43, 9%) (P < .02). Our data do not support the use of tocopherol for prophylaxis against retinopathy of prematurity in premature infants and suggest that IV tocopherol treatment starting on day 1 may increase the incidence of hemorrhagic complications of prematurity, particularly in infants with birth weights of less than 1 kg.

Effect of lactoferrin in the prevention of late-onset sepsis in preterm neonates: a randomized-controlled trial

2021 ◽  
Vol 34 (1) ◽  
pp. 1
Author(s):  
MarwaM Farag ◽  
OmneyaM.K.B Eldin ◽  
MennattAllahH Attia ◽  
NadaI.A Morsi ◽  
RaniaM.A.S El haddad
Keyword(s):  
Randomized Controlled Trial ◽  
Late Onset ◽  
Controlled Trial ◽  
Preterm Neonates ◽  
Randomized Controlled ◽  
Late Onset Sepsis

scholarly journals Oral dexamethasone for the prevention of acute migraine recurrence in pediatric patients presenting to the emergency department with migraine

2018 ◽  
Vol 1 ◽  
pp. 251581631880415
Author(s):  
Serena L Orr ◽  
Lawrence Richer ◽  
Nick Barrowman ◽  
Roger Zemek
Keyword(s):  
Emergency Department ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Pilot Trial ◽  
Recruitment Rate ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
Oral Dexamethasone ◽  
Safety Outcomes

Objective: To assess the feasibility of a randomized controlled trial protocol that aims to determine the efficacy and safety of oral dexamethasone compared to placebo for the prevention of migraine recurrence in children and adolescents visiting the pediatric emergency department (ED) with migraine. Methods: This study was a two-arm, parallel-group, randomized, placebo-controlled, double-blind pilot trial of patients presenting to the pediatric ED with migraine. Eligible participants were randomized at 1:1 ratio to receive either oral dexamethasone 0.6 mg/kg (maximum 15 mg) or matched placebo as a single dose. Efficacy and safety outcomes were assessed at discharge, 48 h and 7 days after discharge. The primary outcome of the trial was feasibility and was assessed through participant recruitment rate, follow-up completion rates, participant satisfaction ratings and comparison of enrolled versus non-enrolled participants. Efficacy and safety outcomes were not analyzed given that this was a pilot study. Results: Twelve participants were enrolled over the 6-month recruitment period. This represents 60% of the planned sample size and a 10.5% recruitment rate. No other feasibility issues were identified and patients expressed high satisfaction rates with their treatment: 90.9% were satisfied with their treatment at discharge and at 48-h follow-up and 81.8% were satisfied with their treatment at 7-day follow-up (81.8%). There were no significant differences observed when comparing enrolled participants to those not enrolled. Conclusion: This pilot randomized controlled trial is the first to assess dexamethasone in the pediatric ED for the prevention of migraine recurrence. The protocol is feasible but recruitment in a single center was lower than expected. Future pediatric ED migraine studies may use innovative or pragmatic trial designs to maximize feasibility from a recruitment standpoint.

Efficacy and Safety of Galantamine Hydrobromide in the Treatment of Mild to Moderate Dementia

2010 ◽  
Vol 2 ◽  
pp. CMT.S5884
Author(s):  
Mark Oremus ◽  
Pasqualina Santaguida ◽  
Parminder Raina
Keyword(s):  
Daily Living ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Disease Course ◽  
Efficacy And Safety ◽  
Screening Process ◽  
Global Function ◽  
Randomized Controlled ◽  
Moderate Dementia

We conducted a systematic review and meta analysis of randomized controlled trials of galantamine hydrobromide in the treatment of mild to moderate dementia. Following a literature search and screening process, we included 15 trials and five companion papers in the review. Moderate-quality evidence suggested galantamine-treated persons generally had better outcomes than placebo-treated persons after a maximum 6-month follow-up. Outcome domains included cognitive function, global function, behaviour and mood, and activities of daily living. The evidence requires careful interpretation because ‘better outcomes’ can mean less deterioration, rather than improvement, relative to placebo. Galantamine has not been shown to halt dementia progression nor reverse disease course. The most frequently reported harms were nausea, diarrhea, and dizziness. Reported rates of these harms were highly variable (range, 0%–40%); reporting was at high risk of bias because authors rarely specified the frequency or timing of harms assessment, nor did they report active methods of collecting harms.

Neurodevelopmental outcomes following neonatal late-onset sepsis and blood culture-negative conditions

2021 ◽  
pp. fetalneonatal-2020-320664
Author(s):  
Sagori Mukhopadhyay ◽  
Karen M Puopolo ◽  
Nellie I Hansen ◽  
Scott A Lorch ◽  
Sara B DeMauro ◽  
...  
Keyword(s):  
Blood Culture ◽  
Late Onset ◽  
Antibiotic Administration ◽  
Adjusted Relative Risk ◽  
Neurodevelopmental Outcomes ◽  
Risk Of Death ◽  
Late Onset Sepsis ◽  
Early Onset Sepsis ◽  
Culture Negative

ObjectiveDetermine risk of death or neurodevelopmental impairment (NDI) in infants with late-onset sepsis (LOS) versus late-onset, antibiotic-treated, blood culture-negative conditions (LOCNC).DesignRetrospective cohort study.Setting24 neonatal centres.PatientsInfants born 1/1/2006–31/12/2014, at 22–26 weeks gestation, with birth weight 401–1000 g and surviving >7 days were included. Infants with early-onset sepsis, necrotising enterocolitis, intestinal perforation or both LOS and LOCNC were excluded.ExposuresLOS and LOCNC were defined as antibiotic administration for ≥5 days with and without a positive blood/cerebrospinal fluid culture, respectively. Infants with these diagnoses were also compared with infants with neither condition.OutcomesDeath or NDI was assessed at 18–26 months corrected age follow-up. Modified Poisson regression models were used to estimate relative risks adjusting for covariates occurring ≤7 days of age.ResultsOf 7354 eligible infants, 3940 met inclusion criteria: 786 (20%) with LOS, 1601 (41%) with LOCNC and 1553 (39%) with neither. Infants with LOS had higher adjusted relative risk (95% CI) for death/NDI (1.14 (1.05 to 1.25)) and death before follow-up (1.71 (1.44 to 2.03)) than those with LOCNC. Among survivors, risk for NDI did not differ between the two groups (0.99 (0.86 to 1.13)) but was higher for LOCNC infants (1.17 (1.04 to 1.31)) compared with unaffected infants.ConclusionsInfants with LOS had higher risk of death, but not NDI, compared with infants with LOCNC. Surviving infants with LOCNC had higher risk of NDI compared with unaffected infants. Improving outcomes for infants with LOCNC requires study of the underlying conditions and the potential impact of antibiotic exposure.

Optimized Detection of Central Apneas Preceding Late-Onset Sepsis in Premature Infants

2021 ◽  
Author(s):  
Gabriele Varisco ◽  
Deedee Kommers ◽  
Xi Long ◽  
Zhuozhao Zhan ◽  
Marina M. Nano ◽  
...  
Keyword(s):  
Premature Infants ◽  
Late Onset ◽  
Late Onset Sepsis ◽  
Central Apneas

scholarly journals Serum Amyloid A, Procalcitonin, Tumor Necrosis Factor-α, and Interleukin-1βLevels in Neonatal Late-Onset Sepsis

2008 ◽  
Vol 2008 ◽  
pp. 1-7 ◽  
Author(s):  
Birsen Ucar ◽  
Bilal Yildiz ◽  
M. Arif Aksit ◽  
Coskun Yarar ◽  
Omer Colak ◽  
...  
Keyword(s):  
Serum Amyloid A ◽  
Late Onset ◽  
Serum Amyloid ◽  
Amyloid A ◽  
Late Onset Sepsis ◽  
Sepsis Score ◽  
Reliable Marker ◽  
Factor Α ◽  
Necrosis Factor

Background. Sepsis is an important cause of mortality in newborns. However, a single reliable marker is not available for the diagnosis of neonatal late-onset sepsis (NLS). The aim of this study is to evaluate the value of serum amyloid A (SAA) and procalcitonin (PCT) in the diagnosis and follow-up of NLS.Methods. 36 septic and healthy newborns were included in the study. However, SAA, PCT, TNF-α, IL-1β, and CRP were serially measured on days 0, 4, and 8 in the patients and once in the controls. Töllner's sepsis score (TSS) was calculated for each patient.Results. CRP, PCT, and TNF-αlevels in septic neonates at each study day were significantly higher than in the controls (P=.001). SAA and IL-1βlevels did not differ from healthy neonates. The sensitivity and specificity were 86.8% and 97.2% for PCT, 83.3% and 80.6% for TNF-α, 75% and 44.4% for SAA on day 0.Conclusion. Present study suggests that CRP seems to be the most helpful indicator and PCT and TNF-αmay be useful markers for the early diagnosis of NLS. However, SAA, IL-1β, and TSS are not reliable markers for the diagnosis and follow-up of NLS.

Matrix-Applied Characterized Autologous Cultured Chondrocytes Versus Microfracture: Five-Year Follow-up of a Prospective Randomized Trial

2018 ◽  
Vol 46 (6) ◽  
pp. 1343-1351 ◽  
Author(s):  
Mats Brittberg ◽  
David Recker ◽  
John Ilgenfritz ◽  
Daniel B.F. Saris ◽  
Keyword(s):  
Clinical Trial ◽  
Informed Consent ◽  
Extension Study ◽  
Cartilage Defects ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
And Function ◽  
Mri Evaluation ◽  
Cultured Chondrocytes

Background: Matrix-based cell therapy improves surgical handling, increases patient comfort, and allows for expanded indications with better reliability within the knee joint. Five-year efficacy and safety of autologous cultured chondrocytes on porcine collagen membrane (MACI) versus microfracture for treating cartilage defects have not yet been reported from any randomized controlled clinical trial. Purpose: To examine the clinical efficacy and safety results at 5 years after treatment with MACI and compare these with the efficacy and safety of microfracture treatment for symptomatic cartilage defects of the knee. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: This article describes the 5-year follow-up of the SUMMIT (Superiority of MACI Implant Versus Microfracture Treatment) clinical trial conducted at 14 study sites in Europe. All 144 patients who participated in SUMMIT were eligible to enroll; analyses of the 5-year data were performed with data from patients who signed informed consent and continued in the Extension study. Results: Of the 144 patients randomized in the SUMMIT trial, 128 signed informed consent and continued observation in the Extension study: 65 MACI (90.3%) and 63 microfracture (87.5%). The improvements in Knee injury and Osteoarthritis Outcome Score (KOOS) Pain and Function domains previously described were maintained over the 5-year follow-up. Five years after treatment, the improvement in MACI over microfracture in the co-primary endpoint of KOOS pain and function was maintained and was clinically and statistically significant ( P = .022). Improvements in activities of daily living remained statistically significantly better ( P = .007) in MACI patients, with quality of life and other symptoms remaining numerically higher in MACI patients but losing statistical significance relative to the results of the SUMMIT 2-year analysis. Magnetic resonance imaging (MRI) evaluation of structural repair was performed in 120 patients at year 5. As in the 2-year SUMMIT (MACI00206) results, the MRI evaluation showed improvement in defect filling for both treatments; however, no statistically significant differences were noted between treatment groups. Conclusion: Symptomatic cartilage knee defects 3 cm2 or larger treated with MACI were clinically and statistically significantly improved at 5 years compared with microfracture treatment. No remarkable adverse events or safety issues were noted in this heterogeneous patient population.

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