scholarly journals Traditional Mongolian swaddling and developmental dysplasia of the hip: a randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Munkhtulga Ulziibat ◽  
Bayalag Munkhuu ◽  
Ariun-Erdene Bataa ◽  
Raoul Schmid ◽  
Thomas Baumann ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Outcome Data ◽  
Developmental Dysplasia ◽  
Monthly Basis ◽  
Randomized Controlled ◽  
Dysplasia Of The Hip

Abstract Background Mongolian traditional swaddling of infants, where arms and legs are extended with a tight wrapping and hips are in adduction position, may lead to abnormal maturation and formation of the hip joint; and is a contributing factor for developmental dysplasia of the hip (DDH). This hypothesis was tested in this randomized controlled trial. Methods Eighty newborns with one or two hips at risk of worsening to DDH (Graf Type 2a; physiologically immature hips) at birth were randomized into 2 groups at a tertiary hospital in Ulaanbaatar. The “swaddling” group (n = 40) was swaddled in the common traditional Mongolian method for a month while the “non-swaddling” group (n = 40) was instructed not to swaddle at all. All enrollees were followed up on monthly basis by hip ultrasound and treated with an abduction-flexion splint if necessary. The groups were compared on the rate of Graf’s “non-Type 1” hips at follow-up controls as the primary outcome. Secondary outcomes were rate of DDH and time to discharge (Graf Type 1; healthy hips). In addition, correlation between the primary outcome and swaddling length in days and frequency of swaddling in hours per day were calculated. Results Recruitment continued from September 2019 to March 2020 and follow-up data were completed in June 2020. We collected final outcome data in all 80 enrollees. Percentages of cases with non-Type 1 hip at any follow-up examination were 7.5% (3/40) in the non-swaddling group and 40% (16/40) in the swaddling group (p = 0.001). There was no DDH case in the non-swaddling group while there were 8 cases of DDH in the swaddling group. The mean time to discharge was 5.1 ± 0.3 weeks in the non-swaddling group and 8.4 ± 0.89 weeks in the swaddling group (p = 0.001). There is a correlation between the primary outcome and the swaddling frequency in hours per day (r = 0.81) and swaddling length in days (r = 0.43). Conclusions Mongolian traditional swaddling where legs are extended and hips are in extension and adduction position increases the risk for DDH. Trial registration Retrospectively registered, ISRCTN11228572.

scholarly journals Timing of surgical intervention for developmental dysplasia of the hip: a randomised controlled trial (Hip ’Op)

2017 ◽  
Vol 21 (63) ◽  
pp. 1-84
Author(s):  
Charlotte L Williams ◽  
Susie Weller ◽  
Lisa Roberts ◽  
Isabel Reading ◽  
Andrew Cook ◽  
...  
Keyword(s):  
Surgical Treatment ◽  
Randomised Controlled Trial ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Health Technology ◽  
Outcome Data ◽  
Developmental Dysplasia ◽  
Qualitative Work ◽  
Randomised Controlled ◽  
Dysplasia Of The Hip

BackgroundDevelopmental dysplasia of the hip (DDH) is a very common congenital disorder, and late-presenting cases often require surgical treatment. Surgical reduction of the hip may be complicated by avascular necrosis (AVN), which occurs as a result of interruption to the femoral head blood supply during treatment and can result in long-term problems. Some surgeons delay surgical treatment until the ossific nucleus (ON) has developed, whereas others believe that the earlier the reduction is performed, the better the result. Currently there is no definitive evidence to support either strategy.ObjectivesTo determine, in children aged 12 weeks to 13 months, whether or not delayed surgical treatment of a congenitally dislocated hip reduces the incidence of AVN at 5 years of age. The main clinical outcome measures were incidence of AVN and the need for a secondary surgical procedure during 5 years’ follow-up. In addition, to perform (1) a qualitative evaluation of the adopted strategy and (2) a health economic analysis based on NHS and societal costs.DesignPhase III, unmasked, randomised controlled trial with qualitative and health economics analyses. Participants were randomised 1 : 1 to undergo either early or delayed surgery.SettingPaediatric orthopaedic surgical centres in the UK.ParticipantsChildren aged 12 weeks to 13 months with DDH, either newly diagnosed or following failed splintage, and who required surgery. We had a target recruitment of 636 children.InterventionsSurgical reduction of the hip performed as per the timing allocated at randomisation.Main outcome measuresPrimary outcome – incidence of AVN at 5 years of age (according to the Kalamchi and MacEwen classification). Secondary outcomes – need for secondary surgery, presence or absence of the ON at the time of primary treatment, quality of life for the main carer and child, and a health economics and qualitative analysis.ResultsThe trial closed early after reaching < 5% of the recruitment target. Fourteen patients were randomised to early treatment and 15 to delayed treatment. Implementation of rescue strategies did not improve recruitment. No primary outcome data were collected, and no meaningful conclusions could be made from the small number of non-qualitative secondary outcome data. The qualitative work generated rich data around three key themes: (1) access to, and experiences of, primary and secondary care; (2) the impact of surgery on family life; and (3) participants’ experiences of being in the trial.LimitationsOveroptimistic estimates of numbers of eligible patients seen at recruiting centres during the planning of the trial, as well as an overestimation of the recruitment rate, may have also contributed to unrealistic expectations on achievable patient numbers.Future workThere may be scope for investigation using routinely available data.ConclusionsHip ’Op has highlighted the importance of accurate advance information on numbers of available eligible patients, as well as support from all participating investigators when conducting surgical research. Despite substantial consultation with parents of children in the planning stage, the level of non-participation experienced during recruitment was much higher than anticipated. The qualitative work has emphasised the need for appropriate advice and robust support for parents regarding the ‘real-life’ aspects of managing children with DDH.Trial registrationCurrent Controlled Trials ISRCTN76958754.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 21, No. 63. See the NIHR Journals Library website for further project information.

scholarly journals Mobilization in the evening reduces delirium in critically ill patients: the MENTAL randomized, controlled trial

2019 ◽  
Author(s):  
Peter Nydahl ◽  
David McWilliams ◽  
Norbert Weiler ◽  
Christoph Borzikowsky ◽  
Fiona Howroyd ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Intervention Group ◽  
Early Mobilization ◽  
Control Group ◽  
Number Needed To Treat ◽  
Randomized Controlled ◽  
Post Hoc

Abstract Background : Delirium is a common complication in patients on Intensive Care Units (ICU). Caring interventions such as early mobilization are effective in prevention and treatment of delirium, but are recommended during daytime. It may be effective in the night, too. Method : The aim of this study was to prove the effect of mobilization in the evening to prevent or treat ICU patients from delirium. The design was a multicentric, randomized, controlled trial in 5 mixed ICUs over a period of 2 weeks with max. 28 days follow-up. Patients in the intervention group were mobilized onto the edge of the bed or more between 9:00 and 11:00 p.m. by an additional mobilization team, following safety criteria. Patients in the control group received usual care. Primary outcome parameter was the duration of a delirium. Secondary parameters were presence of delirium, mortality, duration of mechanical ventilation (MV) and stay, feasibility, and mobilization-related complications. Results : In summary, n=69 patients could be analysed (intervention n=36, control n=33). Due to limited resources, the trial was stopped and reached 62% of targeted sample size. Mobilization in the evening did not significantly reduce duration of existing delirium, delirium presence, length of MV or days in ICU and hospital for 28 days follow-up. In an unplanned post-hoc analysis, mobilization in the evening prevented patients from delirium in the first four days (6 (16.7%) vs. 13 (39.4%), p=0.032), with a number needed to treat of 5. The intervention was feasible in 71.7% of eligible patients, with 13.6% unwanted safety events. Conclusions : In a mixed ICU population, mobilization in the evening did not show a reduction in duration of delirium, MV or length of stay, but a reduction in the incidence of early onset delirium. Mobilization between 9:00 and 11:00 pm. by an interprofessional mobilization team may prevent patients from delirium. The intervention was feasible, safe, and accepted by most patients.

scholarly journals Combination of first-line chemotherapy with Kanglaite injections versus first-line chemotherapy alone for advanced non-small-cell lung cancer: study protocol for an investigator-initiated, multicenter, open-label, randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Ruike Gao ◽  
Ying Zhang ◽  
Wei Hou ◽  
Jie Li ◽  
Guanghui Zhu ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Primary Outcome ◽  
Advanced Nsclc ◽  
Controlled Trial ◽  
First Line ◽  
Open Label ◽  
Randomized Controlled ◽  
Line Chemotherapy

Abstract Background Non-small-cell lung cancer (NSCLC) is usually diagnosed at an advanced stage, and chemotherapy is the main treatment for this disease. Kanglaite injections (KLTi) have been widely used for the treatment of cancer in China. KLTi combined with chemotherapy could improve the short-term efficacy, quality of life, and performance status for NSCLC compared with chemotherapy alone. This trial aims to assess the long-term efficacy and safety of KLTi in combination with chemotherapy for the treatment of advanced NSCLC. Methods This will be an investigator-initiated multicenter open-label randomized controlled trial. We will randomly assign 334 eligible participants with stage IIIA-IV NSCLC to the treatment or control groups in a 1:1 ratio. Patients in both groups will be administered 4–6 cycles of first-line platinum-based double chemotherapy regimens. Patients with complete response, partial response, or stable disease after 4–6 cycles will receive non-platinum single-agent chemotherapy. Patients in the treatment group are to receive intravenous KLTi 200 ml per day continuously for 14 days, commencing on the first day of chemotherapy. The treatment will be discontinued at the time of disease progression or until unacceptable toxicity is noted. The follow-up will be conducted every 2 months until death, loss of follow-up, or 12 months from randomized enrollment. The primary outcome will be progression-free survival (PFS). The secondary outcomes will be the objective response rate, 1-year survival rate, quality of life, living ability, and blood lipids. The safety outcome will be the rate of adverse events. Discussion This study will be the first randomized controlled trial in which PFS is used as the primary outcome to test whether KLTi combined with first-line chemotherapy has superior efficacy and reduced toxicity compared to chemotherapy alone in advanced NSCLC. This will also be the first clinical study to observe the effects of KLTi on blood lipids. Trial registration ClinicalTrials.gov NCT03986528. Prospectively registered on 30 May 2019.

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