Multicentre, randomised controlled trial of physiological-based cord clamping versus immediate cord clamping in infants with a congenital diaphragmatic hernia (PinC): statistical analysis plan
We describe the statistical analysis plan for the clinical trial evaluating the effects of PBCC versus immediate cord clamping on pulmonary hypertension in infants with CDH (PinC trial).DesignThe PinC trial is a multicentre, randomised controlled trial in infants with isolated left-sided CDH, born ≥ 35.0 weeks of gestation. The primary outcome is the incidence of pulmonary hypertension in the first 24 h after birth. Maternal outcomes include estimated maternal blood loss. Neonatal secondary outcomes include mortality before discharge, extracorporeal membrane oxygenation therapy, and number of days of mechanical ventilati...
Source: Trials - March 20, 2024 Category: Research Source Type: clinical trials
Correction: Detailed statistical analysis plan for ALBINO: effect of Allopurinol in addition to hypothermia for hypoxic-ischemic Brain Injury on Neurocognitive Outcome — a blinded randomized placebo-controlled parallel group multicenter trial for superiority (phase III)
(Source: Trials)
Source: Trials - March 15, 2024 Category: Research Source Type: clinical trials
Correction: Statistical analysis plan and protocol updates for Gestational diabetes in Uganda and India: Design and Evaluation of Educational Films for Improving Screening and Self-management (GUIDES) trial
(Source: Trials)
Source: Trials - March 13, 2024 Category: Research Source Type: clinical trials
The clinical effectiveness of a self-management intervention for patients with persistent depressive disorder and their partners/caregivers: results from a multicenter, pragmatic randomized controlled trial
ConclusionAlthough depressive symptoms did not improve relative to CAU, this only confirmed that treatment for patients with treatment-resistant PDD should move from symptom reduction to functional recovery. Also, functional recovery may be reflected in other outcomes than psychosocial burden, such as self-empowerment, in patients with treatment-resistant PDD. Future research on PPEP4All-PDD could focus on a longer-term program and/or online program that may also be offered earlier in the treatment process as an empowerment intervention. Trial registrationNetherlands Trial Register Identifier NL5818. Registered on 20 Jul...
Source: Trials - March 13, 2024 Category: Research Source Type: clinical trials
Statistical analysis plan for the PRO B study: open-label, superiority randomised controlled trial of alarm-based patient-reported outcome monitoring in patients with metastatic breast cancer
ConclusionThis detailed SAP defines the main components of the statistical analysis for the PRO B study to assist the statistician and prevent bias in selecting analysis and reporting findings. Version 1 of the SAP was finalised on January 18, 2024.Trial registrationDRKS (German Clinical Trials Register)DRKS00024015. Registered on February 15, 2021. (Source: Trials)
Source: Trials - March 7, 2024 Category: Research Source Type: clinical trials
Physiological-based cord clamping in very preterm infants: the Aeration, Breathing, Clamping 3 (ABC3) trial —statistical analysis plan for a multicenter randomized controlled trial
DiscussionThe findings of this trial will provide evidence for future clinical guidelines on optimal cord clamping management at birth.Trial registrationClinicalTrials.gov NCT03808051. Registered on 17 January 2019. (Source: Trials)
Source: Trials - March 4, 2024 Category: Research Source Type: clinical trials
Coenzyme Q10 supplementation in burn patients: a double-blind placebo-controlled randomized clinical trial
ConclusionResults showed that in patients with burn injury, CoQ10 administration had no effect on inflammatory markers and oxidative stress, although serum albumin levels were improved after supplementation. Further studies with albumin as the primary outcome are needed to confirm this finding. (Source: Trials)
Source: Trials - March 2, 2024 Category: Research Source Type: clinical trials
Efficacy of propofol-supplemented cardioplegia on biomarkers of organ injury in patients having cardiac surgery using cardiopulmonary bypass: a statistical analysis plan for the ProMPT-2 randomised controlled trial
DiscussionThis manuscript prospectively describes, prior to the completion of data collection and database lock, the analyses to be undertaken for the ProMPT-2 trial to reduce risk of reporting and data-driven analyses.Trial registrationISRCTN ISRCTN15255199. Registered on 26 March 2019. (Source: Trials)
Source: Trials - February 29, 2024 Category: Research Source Type: clinical trials
Physiologically Based Cord Clamping To Improve Neonatal Outcomes In Moderate And Late Preterm Newborns
Conditions: Premature Birth; Respiratory Distress Syndrome in Premature Infant; Sepsis; Intraventricular Hemorrhage of Prematurity; Bronchodysplasia; Jaundice Interventions: Other: Physiological Based Cord Clamping; Other: Differed Cord Clamping Sponsors: Queen Fabiola Children ' s University Hospital; The Belgian Kids Fund; Fonds IRIS-Recherche; Ars Statistica Recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - February 28, 2024 Category: Research Source Type: clinical trials
Protective Anesthesiological Management Procedure Imposes Control on Respiratory Comlications
Conditions: Well-Being, Psychological Interventions: Procedure: The procedure of protective lung ventilation Sponsors: Masa Kontic; Prof.Dinko Tonkovi ć, MD, PhD Head of Department of Anesthesiology, Reanimatology and Intensive Care Medicine and Pain Therapy, University Hospital Centre Zagreb; Assist. Prof. Slavica Sović, MD, PhD Department of Medical Statistics, Epidemiology and Medical Informatics, School of Public Health Andrija Štampar; Pro f. Goran Šimić, MD, PhD Professor of Neuroscience and Anatomy, Chair, Department of Neuroscience, Croatian Institute for Brain Research, University of Zagreb; Prof. Anamarija J...
Source: ClinicalTrials.gov - February 28, 2024 Category: Research Source Type: clinical trials
Physiologically Based Cord Clamping To Improve Neonatal Outcomes After Elective Cesarean Delivery
Conditions: Transient Tachypnea of the Newborn Interventions: Other: Physiological based cord clamping; Other: Differed cord clamping Sponsors: Queen Fabiola Children ' s University Hospital; The Belgian Kids Fund; Fonds IRIS-Recherche; Ars Statistica Recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - February 26, 2024 Category: Research Source Type: clinical trials
Comparing the effects of pulsed and radiofrequency catheter ablation on quality of life, anxiety, and depression of patients with paroxysmal supraventricular tachycardia: a single-center, randomized, single-blind, standard-controlled trial
ConclusionsOur study provided new and meaningful evidence that PFA was effective in significantly improving QOL and decreasing anxiety and depression in PFA patients.Trial registrationChinese Clinical Trial Registry, ChiCTR2200060272. (Source: Trials)
Source: Trials - February 24, 2024 Category: Research Source Type: clinical trials
Statistical analysis plan for the phaco TIp position during clear corneal Phacoemulsification Surgery (TIPS) randomized controlled trial
ConclusionIn this paper, we describe the detailed statistical analysis plan (SAP) for the TIPS trial, which was prepared prior to database lock. The SAP includes details of planned analyses and unpopulated tables, which will be reported in the publications. We plan to lock the database in July 2023 and publish the results later in the same year.SAP Version 0.1 (dated: 28 April 2023)Protocol version:2.0Trial registrationClinical Trial Registry of India CTRI/2019/02/017464. Registered on 5 February 2019;https://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=29764&EncHid=&userName=2019/02/017464 (Source: Trials)
Source: Trials - February 22, 2024 Category: Research Source Type: clinical trials
Exploring critical intervention features and trial processes in the evaluation of sensory integration therapy for autistic children
ConclusionsThe process evaluation was highly valuable in identifying contextual factors that could impact the effectiveness of this individualised intervention. Rigorous evaluations of interventions for autistic children are important, especially given the limitations such as limited sample sizes and short-term follow-up as faced by previous research. One of the challenges lies in the variability of outcomes considered important by caregivers, as each autistic child faces unique challenges. It is crucial to consider the role of parents or other caregivers in facilitating access to these interventions and how this may impac...
Source: Trials - February 17, 2024 Category: Research Source Type: clinical trials
Good Statistical Practice —development of tailored Good Clinical Practice training for statisticians
ConclusionAll research staff should have training in GCP yet the training undertaken by most academic statisticians does not cover activities related to their role. The Good Statistical Practice (GCP for Statisticians) project has developed and extensively piloted new, role-specific, comprehensive, accessible GCP training tailored to statisticians working in clinical research, particularly the clinical trials arena. This role-specific training will encourage best practice, leading to transparent and reproducible statistical activity, as required by regulatory authorities and funders. (Source: Trials)
Source: Trials - February 10, 2024 Category: Research Source Type: clinical trials
