Contemporary clinical trials最新文献

{"title":"Research recruitment strategies in the digital era: Opportunities and challenges of social media","authors":"Lauren Uy ,&nbsp;Nancy Safwan ,&nbsp;Ridwan Ahmad ,&nbsp;Erin R. Uddenberg ,&nbsp;Jana Karam ,&nbsp;Maria D. Hurtado Andrade ,&nbsp;Nicola J. Sykes ,&nbsp;Stephanie S. Faubion ,&nbsp;Chrisandra L. Shufelt","doi":"10.1016/j.cct.2025.108033","DOIUrl":"10.1016/j.cct.2025.108033","url":null,"abstract":"<div><h3>Background</h3><div>Effective recruitment is crucial for clinical research, yet traditional methods can be costly and time-consuming. Digital platforms offer a promising opportunity for reaching broader populations. This paper aims to provide a descriptive analysis of digital and traditional recruitment strategies used to engage women with functional hypothalamic amenorrhea (FHA) and identify the most effective methods.</div></div><div><h3>Methods</h3><div>From January 2023 to November 2024, women aged 18–40 were recruited through traditional methods (flyers, referrals, word-of-mouth, health fairs) and digital platforms (Instagram, X, Facebook, Reddit, podcasts, electronic boards, clinical trial websites, data exploration tool). Respondents were categorized into “All”, “Consented,” and “Completed,” then stratified by generation and geographic location. Enrollment and completion rates were calculated.</div></div><div><h3>Results</h3><div>Among 220 respondents (mean age 28.0 ± 5.9 years), 74 (34 %) consented, and 47 (21 %) completed participation. Of all responses, Instagram provided the highest recruitment (37 %, <em>n</em> = 82), but had the lowest enrollment rate (17 %). Podcasts and word-of-mouth were also effective, with physician referrals yielding the highest enrollment (80 %) and completion (100 %) rates yet representing one of the lowest recruitment counts (<em>n</em> = 5). While digital strategies had three times more outreach, enrollment and completion rates remained similar to those of traditional methods. Millennials (<em>n</em> = 117) relied more on Facebook and Podcasts, while Gen Z (<em>n</em> = 102) engaged more via electronic boards and Reddit.</div></div><div><h3>Conclusions</h3><div>Digital platforms, particularly social media and podcasts showed significant potential to enhance recruitment efficiency and outreach. However, varying completion rates across methods underscore the importance of a multifaceted approach to ensure participant diversity and study generalizability.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"156 ","pages":"Article 108033"},"PeriodicalIF":1.9,"publicationDate":"2025-07-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144752559","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Preference for behavior change strategies in randomized controlled trials: Evidence from weight management","authors":"Michael Sobolev ,&nbsp;Julissa Ruiz ,&nbsp;Márcio A. Diniz ,&nbsp;Hollie Raynor ,&nbsp;Gary D. Foster ,&nbsp;Aaron R. Seitz ,&nbsp;Sarah-Jeanne Salvy","doi":"10.1016/j.cct.2025.108031","DOIUrl":"10.1016/j.cct.2025.108031","url":null,"abstract":"<div><h3>Background</h3><div>Randomized controlled trial participants are expected to embrace assignment to any of the study arms, yet individuals' relative preference for the study arms invariably affects <em>who</em> participates in trials and for <em>how long</em>.</div></div><div><h3>Methods</h3><div>Our ongoing Avoid/Resist trial (1R01DK130851) tests two strategies to bridge the intention-behavior gap in a weight management intervention. <em>Avoid</em> combines pantry makeover and online grocery shopping. <em>Resist</em> involves gamified, inhibitory control training. During screening, individuals rate Avoid and Resist on affective valence (<em>I don't like this</em> – <em>I like this</em>) and instrumental utility (<em>This will not benefit me</em> – <em>This will benefit me</em>) using a 0–100 analogue scale. K-means clustering was used to identify clusters of individuals based on their liking and perceived benefits of the tested strategies before randomization.</div></div><div><h3>Results</h3><div>Among respondents who completed the screener between January 2024 and January 2025 (<em>n</em> = 306; 64 % Female; 40 % Hispanic/Latino), the correlations between liking and perceived benefit ratings were high (&gt;0.70). Median scores of liking and perceived benefits were 90 and 88 for Resist, and 91.5 and 90 for Avoid. K-means clustering revealed 3 groups: (1) highly favorable to Avoid and Resist (all ratings &gt;90; 61 %); (2) relative preference for Resist (22 %); (3) relative preference for Avoid (17 %).</div></div><div><h3>Conclusions</h3><div>Even among individuals willing to be randomized, nearly 40 % had a relative preference for one of the study arms. Additional work is needed to understand the role of relative preference on retention, adherence, and outcomes in weight management trials.</div><div>Trial registration: The study is registered with <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> (<span><span>NCT05143931</span><svg><path></path></svg></span>).</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"156 ","pages":"Article 108031"},"PeriodicalIF":1.9,"publicationDate":"2025-07-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144738424","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Family dyad-focused diabetes self-management intervention (FDSMI) for African American adults with type 2 diabetes: Study protocol","authors":"Jie Hu ,&nbsp;Lorraine C. Mion ,&nbsp;Alai Tan ,&nbsp;Suzanne Bartle-Haring ,&nbsp;Carla Miller ,&nbsp;Joshua J. Joseph","doi":"10.1016/j.cct.2025.108029","DOIUrl":"10.1016/j.cct.2025.108029","url":null,"abstract":"<div><h3>Background</h3><div>Type 2 diabetes is a major risk factor for serious long-term complications; African Americans (AAs) are especially vulnerable as compared to other racial groups. Multiple factors at individual, interpersonal, community, societal, and healthcare system levels contribute to greater difficulty in diabetes self-management. Social support can be a mediating factor.</div></div><div><h3>Objective</h3><div>We will examine a family-dyad-focused intervention to facilitate family support to promote diabetes self-management among middle-aged and older adult AAs with type 2 diabetes (T2D).</div></div><div><h3>Methods</h3><div>We propose a small phase I/II randomized controlled trial (RCT) using virtual group sessions to examine: (1) the feasibility, acceptability and preliminary efficacy of a 10-session dyad-focused diabetes intervention for AA adults with T2D and their family members; and (2) the associations of dyadic lifestyle behaviors and relationships to healthy behaviors and health outcomes over time in patients with T2D. We will recruit 208 AA adult participants (104 patient-family member dyads). Adults with diabetes and A1C &gt; 7.0 % paired with their designated family members will be randomized 1:1 to the intervention or control arm (52 dyads per arm). Each dyad randomized to the intervention arm will receive 1) group sessions focusing on diabetes self-management, behavioral changes and strategies to cope with stress; 2) family dyadic-focused support component in each session; and 3) three individual family telephone feedback sessions. We will collect data at baseline, post-intervention (Month 3) and six-month post-intervention follow-up (Month 9).</div></div><div><h3>Conclusion</h3><div>Findings will provide foundational data to guide future implementation studies of family-dyad interventions for adult AAs with T2D.</div></div><div><h3>Trial registration</h3><div><span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> registry, <span><span>NCT05905575</span><svg><path></path></svg></span>.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"156 ","pages":"Article 108029"},"PeriodicalIF":2.0,"publicationDate":"2025-07-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144706607","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Causal mediation framework for understanding and communicating estimands and analysis strategies in clinical trials","authors":"Zhao Yang ,&nbsp;Shivani Nanda","doi":"10.1016/j.cct.2025.107982","DOIUrl":"10.1016/j.cct.2025.107982","url":null,"abstract":"<div><div>Estimands, introduced in the ICH E9(R1) Addendum, are deeply rooted in the causal inference framework, its widespread implementation and the engagement of functional stakeholders in a clinical trial are in progress. Nevertheless, communicating the estimands to various stakeholders in an easy-to-understand way poses some challenges, the tools used in the causal inference such as counterfactual outcome, directed acyclic graph (DAG), and single-world intervention graph (SWIG) have started to play a valuable role in defining, identifying, and communicating estimands across functional stakeholders. However, a pragmatic question remains: what <em>type of (treatment) effect</em> that the estimand is endeavoring to estimate in handling an intercurrent event? The causal mediation framework sheds light on establishing the connection between estimand and type of effect, and provides an instructively streamlined decision workflow to select the proper analysis strategy for an interested ICE. We elaborate on this connection in detail and hope it can further enhance and facilitate the understanding of estimands and the communication with different stakeholders in a clinical trial.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"156 ","pages":"Article 107982"},"PeriodicalIF":2.0,"publicationDate":"2025-07-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144674041","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Success and cost-effectiveness of strategies to recruit older adults to a behavioral intervention research study","authors":"Eryen Nelson ,&nbsp;Lauren K. Hand ,&nbsp;Allison Glaser ,&nbsp;Tina Lewandowski ,&nbsp;Jeffrey M. Burns ,&nbsp;Milind A. Phadnis ,&nbsp;Jared Bruce ,&nbsp;Catherine F. Siengsukon","doi":"10.1016/j.cct.2025.108010","DOIUrl":"10.1016/j.cct.2025.108010","url":null,"abstract":"<div><h3>Background</h3><div>With a growing population of older adults, there is an increased need to focus on age-related research. However, recruiting this demographic can be difficult due to numerous factors. Therefore, there is a critical need to understand which recruitment methods yield the most successful and cost-effective results amongst older adults.</div></div><div><h3>Methods</h3><div>Multiple recruitment strategies were employed to enroll 200 older adults (ages 60–85) into a randomized controlled trial investigating the impact of a behavioral sleep intervention on cognitive function. Success and cost-effectiveness of each strategy was evaluated, including percentage of participants recruited, contact-to-enrolled conversion percentage, overall cost, and cost per participant.</div></div><div><h3>Results</h3><div>The total contact-to-enrolled conversion rate was 10.2 % with an overall recruitment cost of $20,220 and a per-participant cost of $101. The highest percentage of enrolled participants (49 %) was recruited through the Alzheimer's Disease Research Center (KU ADRC) registry, which had the highest overall cost ($13,175). Radio advertisements, print advertisements, and KU ADRC registry had both high conversion rates (19–33 %) and high per-participant costs ($134–227). Facebook advertisements and friend/family referrals had low per-participant costs ($17 and $0, respectively) and high conversion rates (23 % for both), but only provided 10 % of the enrolled participants.</div></div><div><h3>Conclusion</h3><div>Utilizing multiple recruitment sources is essential for successful recruitment into behavioral research studies. Recruitment sources with higher costs per participant tended to have the highest conversion rate, apart from Facebook and family/friend referrals. While high-cost strategies are likely necessary, including relational and social media-based strategies may offer cost-effective methods for recruiting older adults.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"156 ","pages":"Article 108010"},"PeriodicalIF":2.0,"publicationDate":"2025-07-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144648785","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Rationale and design of the rheumatoid arthritis non-responders to treatment (RANT) study: Use of a bioinformatics platform and “decentralized” clinical recruitment design","authors":"Gregory C. McDermott ,&nbsp;Mary Jeffway ,&nbsp;Thany Seyok ,&nbsp;Harrison Zhang ,&nbsp;Elena Myasoedova ,&nbsp;John M. Davis III ,&nbsp;Jon Giles ,&nbsp;Jonathan Coblyn ,&nbsp;Simon Helfgott ,&nbsp;Elena Massarotti ,&nbsp;Robert Sands ,&nbsp;Michael E. Weinblatt ,&nbsp;Tracy Johansson ,&nbsp;Gabriela Schmajuk ,&nbsp;Kaleb Michaud ,&nbsp;Cassandra Perry ,&nbsp;Susanne Churchill ,&nbsp;Katherine P. Liao","doi":"10.1016/j.cct.2025.108000","DOIUrl":"10.1016/j.cct.2025.108000","url":null,"abstract":"<div><div>The Rheumatoid Arthritis Non-responders to Treatment (RANT) study (<span><span>https://clinicaltrials.gov/study/NCT05447182</span><svg><path></path></svg></span>) uses a novel bioinformatics platform to facilitate a “decentralized” patient oriented clinical study. The goal is to identify genetic factors associated with inadequate response to biologic and targeted synthetic rheumatoid arthritis (RA) medications. The study was advertised through social media, research website postings, and targeted recruitment of potentially eligible patients in academic practices and existing RA research registries. Interested RA patients who failed two or more biologic or targeted synthetic RA therapies completed a self-directed online informed consent and questionnaires on RA treatment history and granted access to electronic health records through a third-party vendor. After confirming eligibility by reviewing participant responses, participants received a blood sample kit by mail, had blood sample tubes drawn locally, and returned the kit by mail to the study genomic lab for whole genome sequencing. The study enrolled 164 eligible patients. The majority of eligible participants were identified through an established RA research registry (<em>n</em> = 101, 61.6 %) and through clinic recruitment at academic practices (<em>n</em> = 47, 28.7 %). Of the participants who were mailed a blood kit, 118/130 (90.7 %) returned the kit with blood sample by mail. Clinical and genetic factors of RA treatment non-responders will be compared to RA treatment responders from established research cohorts. This study demonstrates the feasibility of decentralized patient-oriented clinical studies in medicine, and highlights the importance of “traditional” recruitment methods like patient registries and academic practices. Future study results will identify potential clinical and genetic predictors of treatment refractory RA.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"156 ","pages":"Article 108000"},"PeriodicalIF":2.0,"publicationDate":"2025-07-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144648784","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The effect of dietary education on attitudes and behaviors in hemodialysis patients: A randomized trial","authors":"Zahide Akeren ,&nbsp;Vahide Semerci Çakmak ,&nbsp;Servet Kalyoncuo","doi":"10.1016/j.cct.2025.108011","DOIUrl":"10.1016/j.cct.2025.108011","url":null,"abstract":"<div><h3>Background</h3><div>Hemodialysis patients are at high risk for poor dietary status, primarily due to limited adherence to complex dietary regimens. Inadequate adherence may lead to complications and negatively adversely affect treatment outcomes. Promoting positive dietary attitudes and behavioral change is essential to improve health in this population.</div></div><div><h3>Aim</h3><div>This study aimed to evaluate the impact of a structured dietary education program on dietary attitudes, daily diet intake, and vital signs in hemodialysis patients.</div></div><div><h3>Methods</h3><div>The study was conducted between December 15, 2023, and March 27, 2024, with 34 patients (17 experimental, 17 control) receiving treatment at a public hospital in northeastern Turkey. Data were collected using the Patient Information Form, 24-Hour Diet Recall, Attitude Scale for Dietary Therapy of Hemodialysis Patients (ASDTHP), and Vital Signs Form. The experimental group received structured dietary education in two weekly 40-min sessions. Analyses were performed using BeBIS 9.0 and SPSS 25.</div></div><div><h3>Results</h3><div>The mean age of participants in the experimental group was 59.94 ± 11.80 years; 64.7 % were male, and 64.7 % were primary/middle school graduates. In the experimental group, significant improvements were found in the total ASDTHP score, including the cognition-influenced and diet culture-related behavioral subdimensions (<em>p</em> &lt; 0.05). Additionally, post-intervention analysis showed showed statistically significant reductions in systolic blood pressure, and pulse rate and increase in potassium intake (p &lt; 0.05).</div></div><div><h3>Conclusion</h3><div>Dietary education improved dietary attitudes and positively influenced certain vital signs, including blood pressure, in hemodialysis patients. However, it did not lead to statistically significant changes in other macronutrient and micronutrient intake variables.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"156 ","pages":"Article 108011"},"PeriodicalIF":2.0,"publicationDate":"2025-07-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144642023","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Dismantling open-label placebos and their rationales: A remote 4-arm randomized controlled trial protocol","authors":"Leo Druart ,&nbsp;Parker Lay ,&nbsp;Grayson L. Baird ,&nbsp;Francesca L. Beaudoin ,&nbsp;Julia Totten ,&nbsp;Jodi Sutherland ,&nbsp;Rochelle Rosen ,&nbsp;Michael H. Bernstein","doi":"10.1016/j.cct.2025.108008","DOIUrl":"10.1016/j.cct.2025.108008","url":null,"abstract":"<div><h3>Objective</h3><div>To explore the effect of rationales on placebos described honestly as inactive pills, (open-label placebos; OLPs) on chronic pain.</div></div><div><h3>Design</h3><div>Dismantling 4-arm randomized controlled trial.</div></div><div><h3>Setting</h3><div>Remote study with United-States residents.</div></div><div><h3>Subjects</h3><div>Chronic pain patients aged 18 to 89.</div></div><div><h3>Methods</h3><div>We plan to recruit 340 subjects, randomized before consent (Zelen randomization procedure) into one of 4 groups. Participants in a no-treatment group will not receive any OLPs. Participants in the three OLP groups will be told to take an OLP pill twice daily for 21 days. The information participants are given about placebos will vary. Those in the “Standard-OLP” group will be provided with a rationale similar to those used in prior OLP trials. Those in the “Mindfulness-OLP” group will be provided with a rationale taking a mindfulness approach. Those in the “Control-OLP” group (and no-treatment group) will be provided with length-matched information about pain demographics; no placebo information will be given. This dismantling design will allow us to compare rationales (Standard-OLP vs Mindfulness-OLP), and examine the rationale effect (Standard-OLP or Mindfulness-OLP vs. Control-OLP), the placebo effect (Standard-OLP or Mindfulness-OLP vs. No-treatment), and the pill effect (Control-OLP vs no-treatment). Pain intensity over 42 days is the primary outcome.</div></div><div><h3>Conclusions</h3><div>This trial will investigate how different components of OLPs impact pain among a chronic pain population. We also highlight novel ways to address limitations of prior OLP studies; namely, lack of blinding and improper controls.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"156 ","pages":"Article 108008"},"PeriodicalIF":2.0,"publicationDate":"2025-07-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144625534","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Protocol for a randomized controlled trial to evaluate the impact of daily supplementation with zinc, chromium, vitamin C, and copper on progression of prediabetes in Jakarta, Indonesia","authors":"Rina Agustina ,&nbsp;Erfi Prafiantini ,&nbsp;Alfi R. Putri ,&nbsp;Rachmi Mufida ,&nbsp;Hanifa Hanifa ,&nbsp;Shofura Afifah ,&nbsp;Dicky L. Tahapary ,&nbsp;Anuraj H. Shankar ,&nbsp;Pradana Soewondo","doi":"10.1016/j.cct.2025.108007","DOIUrl":"10.1016/j.cct.2025.108007","url":null,"abstract":"<div><div>The increase in prediabetes globally presents a major public health concern as individuals with prediabetes are at a higher risk of developing type 2 diabetes, highlighting the need for effective interventions. We present an intervention study protocol to evaluate the effects of daily supplementation with zinc, chromium, vitamin C, and copper (ZCC), combined with standard lifestyle interventions, on glucose profiles in prediabetic adults. We will conduct a randomized, double-blind, placebo-controlled trial over 12 months involving 670 prediabetic adults aged 35 to 64 in urban neighborhoods of Jakarta, Indonesia, with access to primary health centers or hospitals providing outpatient services. Participants will be divided into two groups: one will receive daily ZCC tablets (30 mg zinc, 50 μg chromium, 500 mg vitamin C, and 1 mg copper) alongside lifestyle interventions, while the other will receive an identical placebo with the same lifestyle intervention. Primary outcomes will include fasting blood glucose, a 2-h oral glucose tolerance test, hemoglobin A1c, and HOMA-IR levels, as well as the proportion of participants progressing to diabetes or becoming normal. Secondary outcomes will focus on lifestyle changes, lipid profiles, body weight and composition, and safety. Follow-up visits will be scheduled at 3, 6, and 12 months, with compliance monitored through returned tablet counts. This study aims to inform future nutritional interventions for diabetes prevention.</div></div><div><h3>Trial registration</h3><div><span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> ID <span><span>NCT04511468</span><svg><path></path></svg></span>. Registered on June 1st, 2020.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"156 ","pages":"Article 108007"},"PeriodicalIF":1.9,"publicationDate":"2025-07-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144625535","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The effectiveness of knee-chest-flexion maneuver in reducing respiratory distress in elective cesarean section newborns: protocol for a randomized controlled trial","authors":"Febronia L. Shirima ,&nbsp;Annemarie Keus ,&nbsp;Bariki Mchome ,&nbsp;Glory Mangi ,&nbsp;Indya Davies ,&nbsp;Thomas van den Akker ,&nbsp;Blandina T. Mmbaga ,&nbsp;Stuart B. Hooper ,&nbsp;Arjan B. te Pas","doi":"10.1016/j.cct.2025.108006","DOIUrl":"10.1016/j.cct.2025.108006","url":null,"abstract":"<div><h3>Background</h3><div>Cesarean section (CS) birth is a risk factor for respiratory distress (RD) in term and near-term infants, which has been steadily increasing globally. The absence of labor has been linked to RD resulting from planned CS births. Uterine contractions contribute to the dorsiflexed position of the fetus which increases abdominal and trans-pulmonary pressure resulting in lung liquid loss via nose and mouth. We recently demonstrated the feasibility and safety of applying Knee-to-Chest Flexion (KCF), where the newborn was placed in a flexed “fetal” position, leading to lung liquid expulsion.</div><div>In this trial, the effectiveness of the KCF maneuver in reducing RD in infants delivered by planned CS will be examined.</div></div><div><h3>Methods</h3><div>This will be a randomized controlled two-arm trial in which 521 infants born by elective CS at 37–42 weeks gestational age will be randomized, in 1:1 ratio, to receive either a KCF maneuver or standard care, before being followed up for at least 24 h. The study will be conducted at Kilimanjaro Christian Medical Centre hospital and Mawenzi Regional Referral hospital in Tanzania. Consent will be sought from mothers scheduled for elective CS prior to randomization. The primary outcome is the occurrence of respiratory distress. Secondary outcome is admission to Neonatal Care Unit.</div></div><div><h3>Discussion</h3><div>This trial investigates KCF maneuver as an intervention to facilitate lung liquid clearance in newborns born by planned CS. It is anticipated to produce evidence of KCF as a highly cost effective innovation that will improve neonatal outcomes in clinical settings.</div><div><strong>Trial registration number:</strong> <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span>: <span><span>NCT06270823</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"156 ","pages":"Article 108006"},"PeriodicalIF":2.0,"publicationDate":"2025-07-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144625537","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}