scholarly journals Latamoxef for Neonates With Early-Onset Neonatal Sepsis: A Study Protocol for a Randomized Controlled Trial

2021 ◽  
Vol 12 ◽  
Author(s):  
Hui Qi ◽  
Yue-E Wu ◽  
Ya-Li Liu ◽  
Chen Kou ◽  
Ze-Ming Wang ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Controlled Trial ◽  
Neonatal Sepsis ◽  
Early Onset ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Clinical Trial Registry ◽  
Randomized Controlled ◽  
Conventional Regimen ◽  
Multicenter Randomized Controlled Trial

Early-onset neonatal sepsis (EONS), a bacterial infection that occurs within 72 h after birth, is associated with high likelihood of neonatal mortality. Latamoxef, a semi-synthetic oxacephem antibiotic developed in 1980s, has been brought back into empirical EONS treatment in recent years. In the preliminary work, we established a population pharmacokinetics (PPK) model for latamoxef in Chinese neonates. Moreover, in order to better guide clinical treatment, we conducted dose simulation and found that ascending administration frequency could improve the target rate of 70% of patients having a free antimicrobial drug concentration exceeding the MIC during 70% of the dosing interval (70% fT > MIC). Accordingly, this study is aimed to compare the 70% fT > MIC, efficacy and safety between conventional regimen and PPK model regimen for rational use of latamoxef in EONS treatment. A single-blind, multicenter randomized controlled trial (RCT) for latamoxef will be conducted in Chinese EONS patients. Neonates (≤3 days of age, expected number = 114) admitted to the hospital with the diagnosis of EONS and fulfilling inclusion and exclusion criteria will be randomized (ratio of 1:1) to either a conventional regimen (30 mg/kg q12h) or model regimen (20 mg/kg q8h) latamoxef treatment group for at least 3 days. Primary outcome measure will be 70% fT > MIC and secondary outcome indicators will be the latamoxef treatment failure, duration of antibiotic therapy, changes of white blood cell count (WBC), C-reactive protein (CRP) and procalcitonin (PCT), blood culture results during administration and incidence of adverse event (AE)s. Assessments will be made at baseline, initial stage of latamoxef treatment (18–72 h) and before the end of latamoxef treatment. Ethical approval of our clinical trial has been granted by the ethics committee of the Beijing Children’s Hospital (ID: 2020-13-1). Written informed consent will be obtained from the parents of the participants. This trial is registered in the Chinese Clinical Trial Registry (ChiCTR 2000040064).It is hoped that our study will provide a clinical basis for the rational clinical use of latamoxef in EONS treatment.

scholarly journals Electroacupuncture for postoperative pain after nasal endoscopic surgery: study protocol for a pilot randomized controlled trial

2020 ◽  
Author(s):  
Shanshan Li ◽  
Qing Zhang ◽  
Xuan Yin ◽  
Hongyu Yue ◽  
Wei Zhang ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Controlled Trial ◽  
Postoperative Pain ◽  
Endoscopic Surgery ◽  
Short Form ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Randomized Controlled ◽  
Pilot Randomized Controlled Trial

Abstract Background: Postoperative pain is a common disorder that interferes with the quality of sleep after nasal endoscopic surgery and delays postoperative recovery. Acupuncture is an effective tool for pain management. However, electroacupuncture specifically for the relief of postoperative pain after nasal endoscopic surgery has not yet been studied through a randomized controlled trial. Method/Design: A pilotrandomized, sham-controlled, patient- and- assessor-blind trial is designed to evaluate the efficacy and safety of electroacupuncturein managing postoperative pain following nasal endoscopic surgery of sinusitis with nasal polyps. There will be 30participants randomly allocated to an electroacupuncture or non-invasive sham control in a 1:1 ratio. Treatment will be done within 2 hours before operation, immediately after the operation upon arrival to the recovery ward, and once daily for 3 days. The primary outcome of the Pain Numerical Rating Scale (NRS) will be analyzed using the area-under-the-curve (AUC) method. The secondary outcome measures include Heart Rate (HR) and Blood Pressure (BP) after operation, the sleep quality during the hospital stay (Actigragh),Quality of Recovery-15 (QoR-15), and the MOS item short form health survey (SF-36). ITT analysis will be used in this RCT. Discussion: This pilot randomized controlled trial will explore the feasibility of further clinical application for the management of postoperative pain using electroacupuncture treatment, and it will inform the design of a further full-scale trial. Trial Registration: Chinese Clinical Trial Registry, ChiCTR1900024183, Date: 2019-06-29. URL: http://www.chictr.org.cn/showproj.aspx?proj=40573 Keywords: Electroacupuncture; postoperative pain;nasal endoscopic surgery; RCT; randomized controlled trial; clinical trial

scholarly journals Acupuncture of fascia points to relieve hand spasm after stroke: a study protocol for a multicenter randomized controlled trial

2019 ◽  
Author(s):  
zengqiao zhang ◽  
Wei Feng ◽  
Kun-Peng Li ◽  
Jing He ◽  
Li-Ming Jiang ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Hand Function ◽  
Sham Acupuncture ◽  
Clinical Trial Registry ◽  
Rehabilitation Therapy ◽  
Evaluation Indexes ◽  
Randomized Controlled ◽  
Multicenter Randomized Controlled Trial ◽  
Functional Exercise

Abstract Background: The loss of life ability of patients after stroke is mostly caused by the dysfunction of upper limbs, especially hands. Hand functional exercise is the premise of alleviating hand dysfunction, and the relief of hand spasm is the basis of timely and effective hand functional exercise. Previous clinical observation showed that fascial point needling could effectively alleviate hand spasm immediately after stroke, but further evidence from large sample studies is needed. The overall objective of this trial is to further evaluate the clinical efficacy of fascial point acupuncture on hand spasm after stroke. Methods/design: This multicenter randomized controlled trial will compare the efficacy of fascial point acupuncture versus sham acupuncture and routine rehabilitation therapy in stroke patients with hand spasm. Patients will be randomized to undergo either the fascial point acupuncture or the sham acupuncture or the control (routine rehabilitation therapy). We will recruit 210 stroke inpatients who meet the trial criteria and observe the remission of hand spasm and improvement of limb function after 4 weeks of intervention. The first evaluation indexes are the remission of hand spasm and the duration of spasm remission. The second evaluation indexes are the hand function of affected limbs and the ability of daily living. When the accumulative total number of cases included reaches 120, a mid-term analysis will be conducted to determine any evidence that experimental intervention does have an advantage. Discussion: Our aim is to evaluate the efficacy of fascial point acupuncture in relieving hand spasm after stroke. The results will provide more evidences for the clinical application of this therapy in the future. Trial registration: The trial has been registered at the Chinese Clinical Trial Registry（ChiCTR）on April 9, 2019. Registration number: ChiCTR1900022379 Keywords: Fascia points, Acupuncture, Spasm, Stroke

scholarly journals Efficacy and safety of dual intravenous artesunate plus quinine compared to intravenous artesunate for cerebral malaria in a triple blinded parallel multisite randomized controlled trial in Nigerian children: DUAL PAQ TRIAL Protocol

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Michael Abel Alao ◽  
Adebola Emmanuel Orimadegun ◽  
Olayinka Rasheed Ibrahim ◽  
Abayomi O. Oyenuga ◽  
Adanze Onyenonachi Asinobi ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Cerebral Malaria ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Efficacy And Safety ◽  
Current Standard ◽  
Clinical Trial Registry ◽  
Nigerian Children ◽  
Randomized Controlled ◽  
Tertiary Hospitals

Abstract Background Evidence exists as to the criticality of the first 24 h in the management of cerebral malaria. The morbidity and the mortality rate (35%) with the current intravenous monotherapy for the initial treatment of cerebral malaria are unacceptably high. Combination therapy and a shorter course of effective medication have been shown to improve outcomes in human participants in the treatment of other diseases. This study outlines a protocol to conduct a triple blinded parallel randomized controlled trial on cerebral malaria using dual intravenous medications compared to the current standard of monotherapy. Methods This is a parallel multi-site randomized controlled superiority triple blinded trial consisting of intravenous artesunate plus quinine and a control arm of intravenous artesunate only. Eligible and assenting children aged 6 months to 17 years will be recruited from 4 tertiary hospitals by random selection from the list of tertiary hospitals in Nigeria. Participants will be randomized and assigned in parallel into two arms using random numbers generated from GraphPad Prism (version 9) by a clinical pharmacologist who has no link with the investigators, the patients, or the statistician. The primary measurable outcome is survival at 12, 24, and 48 h post-randomization. A composite secondary outcome consists of the number of children that regained consciousness, parasitaemia and defervescence at 12 and 24 h post-randomization and haematological and inflammatory markers at 24 and 48 h post-randomization. Adverse events both solicited and unsolicited are recorded all through the study post-randomization. The study is approved by the State Research Ethics Review Committee. Data analysis will be performed in GraphPad Prism version 9. Discussion The outcome of this analysis will give insight into the efficacy and safety of dual intravenous antimalaria in the treatment of cerebral malaria among Nigerian children compared with the standard of care. The safety profile of this intervention will also be highlighted. This may help inform physicians on the optimal treatment for cerebral malaria to improve outcomes and reduce recrudescence and treatment failure. Trial registration Pan Africa Clinical Trial Registry PACTR202102893629864. 23/02/2021.

scholarly journals Acupuncture of fascia points to relieve hand spasm after stroke: a study protocol for a multicenter randomized controlled trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Zeng-Qiao Zhang ◽  
Kun-Peng Li ◽  
Jing He ◽  
Li-Ming Jiang ◽  
Wu Wang ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Hand Function ◽  
Sham Acupuncture ◽  
Clinical Trial Registry ◽  
Rehabilitation Therapy ◽  
Randomized Controlled ◽  
Multicenter Randomized Controlled Trial ◽  
Functional Exercise ◽  
Term Analysis

Abstract Background The loss of functional ability of patients after stroke is mostly caused by dysfunction of the upper limbs, especially the hands. Hand functional exercise is the premise of alleviating hand dysfunction, and the relief of hand spasm is the basis of timely and effective hand functional exercise. Previous clinical observation have shown that fascial-point needling can effectively alleviate hand spasm immediately after stroke, but further evidence from large-sample studies is needed. The overall objective of this trial is to further evaluate the clinical efficacy of fascial-point acupuncture on hand spasm after stroke. Methods/design This multicenter randomized controlled trial will compare the efficacy of fascial-point acupuncture versus sham acupuncture and routine rehabilitation therapy in stroke patients with hand spasm. Patients will be randomized to undergo either the fascial-point acupuncture, the sham acupuncture or the control (routine rehabilitation therapy). We will recruit 210 stroke inpatients who meet the trial criteria and observe the remission of hand spasm and improvement of limb function after 4 weeks of intervention. The first evaluation indices are the remission of hand spasm and the duration of spasm remission. The second evaluation indices are the hand function of the affected limbs and the activities of daily living. When the accumulative total number of cases included reaches 120, a mid-term analysis will be conducted to determine any evidence that experimental intervention does have an advantage. Discussion Our aim is to evaluate the efficacy of fascial-point acupuncture in relieving hand spasm after stroke. The results should provide more evidence for the clinical application of this therapy in the future. Trial registration Chinese Clinical Trial Registry (ChiCTR), ID: ChiCTR1900022379. Registered on 9 April 2019

scholarly journals Chinese Classical Prescription (Liang-Xue-Di-Huang Decoction) for Hemorrhoidal Disease: study protocol for a randomized controlled trial

2019 ◽  
Author(s):  
Qing Zhou ◽  
Shuo-yang Shi ◽  
Ben-sheng Wu ◽  
Cheng-biao Xu ◽  
Ji Geng ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Hemorrhoidal Disease ◽  
Secondary Outcome ◽  
Efficacy And Safety ◽  
Clinical Trial Registry ◽  
Double Blind ◽  
Randomized Controlled ◽  
Objective Evidence ◽  
Agent Group

Abstract Background: Hemorrhoidal disease (HD) is one of the commonest proctologic condition in the general population. Medical therapy for HD has not been formally confirmed due to the inconsistent of results. Liang-Xue-Di-Huang Decoction, a kind of ancient Chinese classical prescription, has been used to treat HD from the 19th century in China. However, clinical research of Liang-Xue-Di-Huang Decoction in the treatment of HD is lack. We designed this study to evaluate the efficacy and safety of Liang-Xue-Di-Huang Decoction in the treatment of HD. Methods/Design: A randomized, controlled, double blind, double-mimetic agent and multicenter trial to evaluate the efficacy and safety of Liang-Xue-Di-Huang Decoction is proposed. HD patients (stage I, Ⅱ, Ⅲ) will be randomly assigned into Liang-Xue-Di-Huang Decoction with the addition of Diosmine mimetic agent group and Diosmine with the addition of Liang-Xue-Di-Huang Decoction mimetic agent group. Patients will receive a 7-day treatments and a 7-day follow-up. The primary outcome measure is the French Bleeding Score in 7 and 14 days. The Secondary outcome measures are Goligher Prolapse Score and Quality-of-Life Score in 7 and 14 days. Discussion: This study will provide objective evidence to evaluate the efficacy and safety of Liang-Xue-Di-Huang Decoction in treatment of HD. Trial registration: Chinese Clinical Trial Registry. ChiCTR-1900022531.Registered 19 Apr 2019, http://www.chictr.org.cn/listbycreater.aspx. Keywords: Hemorrhoidal disease, Liang-Xue-Di-Huang Decoction, Chinese classical prescription, Randomized controlled trial.

scholarly journals TEAS treatment improves gastrointestinal function after abdominal surgery: study protocol for a prospective randomized controlled trial

2020 ◽  
Author(s):  
Yafan Bai ◽  
Chao Gao ◽  
Wenjing Li ◽  
Yi Du ◽  
Lixin An
Keyword(s):  
Randomized Controlled Trial ◽  
Abdominal Surgery ◽  
Perioperative Complications ◽  
Controlled Trial ◽  
Length Of Hospital Stay ◽  
Secondary Outcome ◽  
Clinical Trial Registry ◽  
Colorectal Cancer Surgery ◽  
Randomized Controlled ◽  
Function Recovery

Abstract Background : Postoperative gastrointestinal (GI) dysfunction (PGD) is a common problem after abdominal surgery. PGD can increase the length of hospital stay and the economic burden and may even lead to some serious complications. Acupuncture and moxibustion are alternative therapies recommended for PGD. However, the effect of preventive application of acupuncture or transcutaneous electrical acupuncture stimulation (TEAS) is still uncertain. The purpose of this study is to investigate the efficacy of the continuous application of TEAS on GI function recovery in patients after abdominal surgery. At the same time, we will try to confirm the mechanism of TEAS through the brain-gut axis.Methods/design : This study is a prospective, single-center, two-arm, randomized controlled trial that will be performed in a general hospital. In total, 280 patients scheduled for gastric or colorectal cancer surgery will be stratified into two groups. The experimental group will receive TEAS stimulation at Hegu (L14) and Neiguan (PC6), Zusanli (ST36), and Shangjuxu (ST37) once a day for 30 min during and after surgery until GI function recovery. The sham group will receive pseudo-TEAS at sham acupoints. The primary outcome will be the recovery time of postoperative bowel sounds, flatus, bowel movements and the changes in perioperative brain-intestinal peptides. The secondary outcome will be postoperative pain, perioperative complications, and hospitalization duration.Discussion : The results of this study will demonstrate that continuous preventive application of TEAS can improve the GI function recovery in patients undergoing abdominal surgery and that this effect may act through brain-gut peptides.Trial registration: Chinese Clinical Trial Registry, ID: ChiCTR1900023263, Registered on 11 May 2019,http://www.chictr.org.cn

scholarly journals Evaluating the myopia progression control efficacy of defocus incorporated multiple segments (DIMS) lenses and Apollo progressive addition spectacle lenses (PALs) in 6- to 12-year-old children: study protocol for a prospective, multicenter, randomized controlled trial

2020 ◽  
Author(s):  
Yan Li ◽  
Yafei Fu ◽  
Kai Wang ◽  
Zhiming Liu ◽  
Xiaoqing Shi ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Primary School ◽  
School Children ◽  
Controlled Trial ◽  
Primary School Children ◽  
Secondary Outcome ◽  
Myopia Progression ◽  
Randomized Controlled ◽  
Multicenter Randomized Controlled Trial

Abstract Background: Myopia is increasing in prevalence and is currently recognized as a significant public health issue worldwide, particularly in China. Once myopia develops, appropriate clinical interventions need to be prescribed to slow its progression. Currently, several evidences indicate that myopic defocus (MD) retards eye growth and myopia progression. However, no clinical trials have compared the outcomes of different MD spectacle lenses in the same observational group, especially in mainland China. The aim of the present study is to compare the myopia control efficiency of two different MD spectacle lenses, i.e., defocus incorporated multiple segments (DIMS) lenses and Apollo progressive addition spectacle lenses (PALs). Methods: The trial is designed as a 3-year, prospective, randomized, multicenter clinical trial of school children treated with DIMS lenses and PALs. A total of 600 Chinese primary school children aged 6-12 years will be recruited, and each group is intended to include 300 subjects. The inclusion criteria are myopia between −1.00 and −5.00 D and astigmatism ≤1.50 D. The follow-up time points will be 1 month (m), 3 m, 6 m, 12 m, 18 m, 24 m, 30 m, and 36 m. The primary outcome will be determined by the difference in cycloplegic spherical equivalent refraction (SER) between baseline and the last follow-up visit between the two groups. The secondary outcome is the axial length, and the exploratory outcomes include ocular biometric measures, peripheral refraction, binocular vision, accommodation, compliance and the results of questionnaires related to wearing experiences. Discussion: The present study will be the first randomized controlled trial in primary school myopic children with the treatment of DIMS lenses and PALs in China. The results will indicate whether and how much different MD mechanisms retards myopia progression and axial elongation. In addition, the comparison will provide information on the clinical efficacy and safety of DIMS lenses and PALs, including information related to wearing experiences and visual functions

382 INTRATHORACIC VERSUS CERVICAL ANASTOMOSIS AFTER MINIMALLY INVASIVE ESOPHAGECTOMY FOR OESOPHAGEAL CANCER: A RANDOMIZED CONTROLLED TRIAL (ICAN TRIAL)

2021 ◽  
Vol 34 (Supplement_1) ◽  
Author(s):  
Moniek Verstegen ◽  
Frans Workum ◽  
Bastiaan Klarenbeek ◽  
Stefan Bouwense ◽  
Suzanne Gisbertz ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Minimally Invasive ◽  
Controlled Trial ◽  
Minimally Invasive Esophagectomy ◽  
Secondary Outcome ◽  
Ivor Lewis ◽  
Invasive Esophagectomy ◽  
Randomized Controlled ◽  
Multicenter Randomized Controlled Trial ◽  
Robust Evidence

Abstract   Robust evidence is lacking whether Ivor Lewis minimally invasive esophagectomy (MIE) or McKeown MIE should be preferred for patients with mid to distal esophageal or gastro-esophageal junction Siewert I-II (GEJ) cancer. Methods In this multicenter randomized controlled trial, patients with esophageal (below the level of the carina) or GEJ cancer planned for curative resection were recruited. Eligible patients were randomly assigned (1:1) to either Ivor Lewis MIE or McKeown MIE. The primary endpoint was anastomotic leakage (AL) requiring endoscopic, radiologic or surgical intervention. Secondary outcome parameters were overall AL rate, postoperative complications, length of stay and mortality. Results A total of 262 patients were randomly assigned to Ivor Lewis MIE (n = 130) or McKeown MIE (n = 132). Seventeen patients were excluded due to not meeting inclusion criteria (n = 2), physical unfitness for surgery (n = 3), patients’ choice (n = 3), interval metastases (n = 5) or peroperative metastases (n = 4). AL necessitating reintervention occurred in 15 (12.3%) of 122 patients after Ivor Lewis MIE and in 39 (31.7%) of 123 patients after McKeown MIE (RR 0.39, 95%CI 0.22–0.65). Severe complications (Clavien-Dindo ≥3b) were observed in 10.7% after Ivor Lewis MIE and in 22.0% after McKeown MIE (RR 0.49, 95%CI 0.25–0.88). Conclusion This study provides evidence for a lower rate of AL requiring reintervention after Ivor Lewis MIE compared to McKeown MIE for patients with mid to distal esophageal or GEJ cancer.

scholarly journals Computer-based patient education is non-inferior to nurse counselling prior to colonoscopy: a multicenter randomized controlled trial

Endoscopy ◽  
2020 ◽  
Author(s):  
Govert Veldhuijzen ◽  
Michael Klemt-Kropp ◽  
Jochim S. Terhaar sive Droste ◽  
Bas van Balkom ◽  
Aura A. J. van Esch ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Patient Education ◽  
Sickness Absence ◽  
Bowel Preparation ◽  
Protocol Analysis ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Randomized Controlled ◽  
Multicenter Randomized Controlled Trial ◽  
Computer Based

Abstract Background Optimal patient education prior to colonoscopy improves adherence to instructions for bowel preparation and leads to cleaner colons. We developed computer-based education (CBE) supported by video and 3 D animations. We hypothesized that CBE could replace nurse counselling without loss of bowel preparation quality during colonoscopy. Methods We conducted a prospective, multicenter, endoscopist-blinded, non-inferiority randomized controlled trial. The primary outcome was adequate bowel preparation, evaluated using the Boston Bowel Preparation Scale (BBPS). Secondary outcome measures were: sickness absence for outpatient clinic visits; patient anxiety/satisfaction scores; and information recall. We included patients in four endoscopy units (rural, urban, and tertiary). Results We screened 1035 eligible patients and randomized 845. After evaluation, 684 were included in the intention-to-treat (ITT) group. Subsequently, 497 patients were included in the per-protocol analysis, 217 in the nurse counselling and 280 in the CBE group. Baseline characteristics were similarly distributed among the groups. On per-protocol analysis, adequate bowel cleansing was achieved in 93.2 % (261/280) of CBE patients, which was non-inferior to nurse-counselled patients (94.0 %; 204/217), with a difference of −0.8 % (95 % confidence interval [CI] −5.1 % to 3.5 %). Non-inferiority was confirmed in the ITT population. Sickness absence was significantly more frequent in nurse-counselled patients (28.0 % vs. 4.8 %). In CBE patients, 21.5 % needed additional information, with 3.0 % needing an extra outpatient visit. Conclusion CBE is non-inferior to nurse counselling in terms of bowel preparation during colonoscopy, with lower patient sickness leave. CBE may serve as an efficient educational tool to inform patients before colonoscopy in routine clinical practice.

scholarly journals Evaluating the myopia progression control efficacy of defocus incorporated multiple segments (DIMS) lenses and Apollo progressive addition spectacle lenses (PALs) in 6- to 12-year-old children: study protocol for a prospective, multicenter, randomized controlled trial

2019 ◽  
Author(s):  
Yan Li ◽  
Yafei Fu ◽  
Kai Wang ◽  
Zhiming Liu ◽  
Xiaoqing Shi ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Controlled Trial ◽  
Primary School ◽  
School Children ◽  
Controlled Trial ◽  
Primary School Children ◽  
Public Health Issue ◽  
Myopia Progression ◽  
Randomized Controlled ◽  
Multicenter Randomized Controlled Trial

Abstract Background: Myopia is increasing in prevalence and is currently recognized as a significant public health issue worldwide, particularly in China. Once myopia develops, appropriate clinical interventions need to be prescribed to slow its progression. Currently, solid evidence indicates that myopic defocus (MD) retards eye growth and myopia progression. However, no clinical trial has compared the outcomes of different MD spectacle lenses in the same observational group, especially in mainland China. The aim of the present study is to compare the myopia control efficiency of two different MD spectacle lenses, i.e., defocus incorporated multiple segments (DIMS) and Apollo progressive addition spectacle lenses (PALs). Methods: The trial is a 3-year, prospective, randomized, multicenter clinical trial of school children with DIMS and PALs. A total of 600 Chinese primary school children aged 6-12 years will be recruited, and each group is intended to include 300 subjects. The inclusion criteria are myopia between −1.00 and −5.00 D and astigmatism ≤1.50 D. The primary outcomes are cycloplegic spherical equivalent refraction (SER), measured at 6-month intervals, and the changes between groups compared over the study period. The secondary outcomes are axial length, compliance and questionnaires related to wearing experiences. The exploratory outcomes include ocular biometric measures, peripheral refraction, binocular vision, and accommodation. Discussion: The present study is the first randomized controlled trial of DIMS and PALs treatment for primary school children with myopia in China. The results will indicate whether and how much of different MD mechanisms approach retards myopia progression and axial elongation. In addition, the comparison will provide information on the clinical effectiveness and safety of DIMS and APLs, including wearing experiences, visual functions, etc.Trial registration: Chinese Clinical Trial Registry (ChiCTR) Identifier: ChiCTR1900025645. Date of registration: 3 September 2019. http://www.chictr.org.cn/showproj.aspx?proj=42927

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