scholarly journals Longitudinal Study of music Therapy’s Effectiveness for Premature infants and their caregivers (LongSTEP): protocol for an international randomised trial

BMJ Open ◽  
2019 ◽  
Vol 9 (8) ◽  
pp. e025062 ◽  
Author(s):  
Claire Ghetti ◽  
Łucja Bieleninik ◽  
Mari Hysing ◽  
Ingrid Kvestad ◽  
Jörg Assmus ◽  
...  
Keyword(s):  
Preterm Infants ◽  
Neonatal Intensive Care ◽  
Infant Development ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Developmentally Appropriate ◽  
Well Being ◽  
Positive Effects ◽  
Implementation And Dissemination ◽  
Randomised Controlled

IntroductionPreterm birth has major medical, psychological and socioeconomic consequences worldwide. Music therapy (MT) has positive effects on physiological measures of preterm infants and maternal anxiety, but rigorous studies including long-term follow-up are missing. Drawing on caregivers’ inherent resources, this study emphasises caregiver involvement in MT to promote attuned, developmentally appropriate musical interactions that may be of mutual benefit to infant and parent. This study will determine whether MT, as delivered by a qualified music therapist during neonatal intensive care unit (NICU) hospitalisation and/or in home/municipal settings following discharge, is superior to standard care in improving bonding between primary caregivers and preterm infants, parent well-being and infant development.Methods and analysisDesign:international multicentre, assessor-blind, 2×2 factorial, pragmatic randomised controlled trial; informed by a completed feasibility study.Participants:250 preterm infants and their parents.Intervention:MT focusing on parental singing specifically tailored to infant responses, will be delivered during NICU and/or during a postdischarge 6-month period.Primary outcome:changes in mother–infant bonding at 6-month corrected age (CA), as measured by the Postpartum Bonding Questionnaire.Secondary outcomes: mother–infant bonding at discharge and at 12-month CA; child development over 24 months; and parental depression, anxiety and stress, and infant rehospitalisation, all over 12 months.Ethics and disseminationThe Regional Committees for Medical and Health Research Ethics approved the study (2018/994/REK Nord, 03 July 2018). Service users were involved in development of the study and will be involved in implementation and dissemination. Dissemination of findings will apply to local, national and international levels.Trial registration numberNCT03564184

Direct swallowing training and oral sensorimotor stimulation in preterm infants: a randomised controlled trial

2021 ◽  
pp. fetalneonatal-2021-321945
Author(s):  
Ju Sun Heo ◽  
Ee-Kyung Kim ◽  
Sae Yun Kim ◽  
In Gyu Song ◽  
Young Mi Yoon ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Preterm Infants ◽  
Neonatal Intensive Care ◽  
Controlled Trial ◽  
Tube Feeding ◽  
Tertiary Hospital ◽  
Oral Feeding ◽  
Very Preterm Infants ◽  
Very Preterm ◽  
Randomised Controlled

ObjectiveTo evaluate the effects of direct swallowing training (DST) alone and combined with oral sensorimotor stimulation (OSMS) on oral feeding ability in very preterm infants.DesignBlinded, parallel group, randomised controlled trial (1:1:1).SettingNeonatal intensive care unit of a South Korean tertiary hospital.ParticipantsPreterm infants born at <32 weeks of gestation who achieved full tube feeding.InterventionsTwo sessions per day were provided according to the randomly assigned groups (control: two times per day sham intervention; DST: DST and sham interventions, each once a day; DST+OSMS: DST and OSMS interventions, each once a day).Primary outcomeTime from start to independent oral feeding (IOF).ResultsAnalyses were conducted in 186 participants based on modified intention-to-treat (63 control; 63 DST; 60 DST+OSMS). The mean time from start to IOF differed significantly between the control, DST and DST+OSMS groups (21.1, 17.2 and 14.8 days, respectively, p=0.02). Compared with non-intervention, DST+OSMS significantly shortened the time from start to IOF (effect size: −0.49; 95% CI: −0.86 to –0.14; p=0.02), whereas DST did not. The proportion of feeding volume taken during the initial 5 min, an index of infants’ actual feeding ability when fatigue is minimal, increased earlier in the DST+OSMS than in the DST.ConclusionsIn very preterm infants, DST+OSMS led to the accelerated attainment of IOF compared with non-intervention, whereas DST alone did not. The effect of DST+OSMS on oral feeding ability appeared earlier than that of DST alone.Trial registration numberClinicalTrials.gov Registry (NCT02508571).

Randomised trial of estimating oral endotracheal tube insertion depth in newborns using weight or vocal cord guide

2017 ◽  
Vol 103 (4) ◽  
pp. F312-F316 ◽  
Author(s):  
Irwin Gill ◽  
Aisling Stafford ◽  
Madeleine C Murphy ◽  
Aisling R Geoghegan ◽  
Miranda Crealey ◽  
...  
Keyword(s):  
Endotracheal Tube ◽  
Vocal Cord ◽  
Neonatal Intensive Care ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Newborn Infants ◽  
Maternity Hospital ◽  
Thoracic Vertebra ◽  
Insertion Depth ◽  
Randomised Controlled

BackgroundWhen intubating newborns, clinicians aim to position the endotracheal tube (ETT) tip in the midtrachea. The depth to which ETTs should be inserted is often estimated using the infant’s weight. ETTs are frequently incorrectly positioned in newborns, most often inserted too far. Using the vocal cord guide (a mark at the distal end of the ETT) to guide insertion depth has been recommended.ObjectiveTo determine whether estimating ETT insertion depth using the vocal cord guide rather than weight results in more correctly positioned ETT tips.DesignSingle-centre randomised controlled trial.SettingLevel III neonatal intensive care unit (NICU) at a university maternity hospital (National Maternity Hospital, Dublin, Ireland).PatientsNewborn infants without congenital anomalies intubated in the NICU.InterventionsParticipants were randomised to have ETT insertion depth estimated using weight [insertion depth (cm) = weight (kg) +6] or vocal cord guide.Main outcome measureCorrect ETT position, that is, tip between the upper border of the first thoracic vertebra (T1) and the lower border of the second thoracic vertebra (T2) on a chest X-ray as determined by one paediatric radiologist masked to group assignment.Results136 participants were randomised. The proportion of correctly positioned ETTs was similar in both groups (weight 30/69 (44%) vs vocal cord guide 27/67 (40%), p=0.731). Most incorrectly positioned ETT (69/79, 87%) were too low.ConclusionEstimating ETT insertion depth using the vocal cord guide did not result in more correctly positioned ETT tips.Trial registration numberISRCTN39654846.

scholarly journals Improving body image at scale among Brazilian adolescents: study protocol for the co-creation and randomised trial evaluation of a chatbot intervention

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
E. L. Matheson ◽  
H. G. Smith ◽  
A. C. S. Amaral ◽  
J. F. F. Meireles ◽  
M. C. Almeida ◽  
...  
Keyword(s):  
Body Image ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Cost Effective ◽  
Well Being ◽  
Effective Interventions ◽  
Adolescent Girls And Boys ◽  
Registration Number ◽  
Mental Health Interventions ◽  
Randomised Controlled

Abstract Background Body image concerns are prevalent among Brazilian adolescents and can lead to poor psychological and physical health. Yet, there is a scarcity of culturally-appropriate, evidence-based interventions that have been evaluated and made widely available. Chatbot technology (i.e., software that mimics written or spoken human speech) offers an innovative method to increase the scalability of mental health interventions for adolescents. The present protocol outlines the co-creation and evaluation of a body image chatbot for Brazilian adolescents via a partnership between academics, industry organisations and the United Nations Children’s Fund (UNICEF). Methods A two-armed fully remote randomised controlled trial will evaluate the chatbot’s effectiveness at improving body image and well-being. Adolescent girls and boys (N = 2800) aged 13–18 years recruited online will be randomly allocated (1:1) into either: 1) a body image chatbot or 2) an assessment-only control condition. Adolescents will engage with the chatbot over a 72-hour period on Facebook Messenger. Primary outcomes will assess the immediate and short-term impact of the chatbot on state- and trait-based body image, respectively. Secondary outcomes will include state- and trait-based affect, trait self-efficacy and treatment adherence. Discussion This research is the first to develop an evidence-informed body image chatbot for Brazilian adolescents, with the proposed efficacy trial aiming to provide support for accessible, scalable and cost-effective interventions that address disparities in body image prevalence and readily available resources. Trial registration number NCT04825184, registered 30th March 2021.

scholarly journals Effects of yoga on well-being and healthy ageing: study protocol for a randomised controlled trial (FitForAge)

BMJ Open ◽  
2019 ◽  
Vol 9 (5) ◽  
pp. e027386 ◽  
Author(s):  
Josefine Östh ◽  
Vinod Diwan ◽  
Maria Jirwe ◽  
Vishal Diwan ◽  
Anita Choudhary ◽  
...  
Keyword(s):  
Physical Activity ◽  
Older Adults ◽  
Randomised Controlled Trial ◽  
Study Protocol ◽  
Controlled Trial ◽  
Well Being ◽  
Healthy Ageing ◽  
Positive Effects ◽  
Randomised Controlled ◽  
Improve Health

IntroductionDue to ageing populations worldwide, the burden of disability is increasing. It is therefore important to develop interventions that improve healthy ageing, reduce disability onset and enhance life quality. Physical activity can promote healthy ageing and help maintain independence, yet many older adults are inactive. Yoga is a form of physical activity that aims to improve health and may be particularly suitable for older adults. Research indicates positive effects of yoga on several health-related outcomes; however, empirical studies examining the benefits of yoga on well-being among the elderly remain scarce. This study protocol reports the methodology for a 12-week yoga programme aimed to improve health and well-being among physically inactive older adults.Methods and analysisThree group parallel, single-blind randomised controlled trial. Two comparison groups are included: aerobic exercise and a non-active wait-list control. In total, 180 participants aged 65–85 years will be recruited. Assessments will be performed at baseline and postintervention (12-week follow-up). The primary outcome is subjective well-being. Secondary outcomes include physical activity/sedentary behaviour, mobility/fall risk, cognition, depression, anxiety, mood, stress, pain, sleep quality, social support and cardiometabolic risk factors. Data will be analysed using intention-to-treat analyses, with mixed linear modelling.Ethics and disseminationThis study is approved by the Ethical Review Board in Stockholm (2017/1862-31/2). All participants must voluntarily agree to participate and are free to withdraw from the study at any point. Written informed consent will be obtained from each participant prior to inclusion. Results will be available through research articles and conferences. A summary of key results will be publicly available through newspaper articles.Trial registration numberDRKS00015093, U1111-1217-4248

scholarly journals Randomised trial of azithromycin to eradicate Ureaplasma in preterm infants

2020 ◽  
Vol 105 (6) ◽  
pp. 615-622 ◽  
Author(s):  
Rose Marie Viscardi ◽  
Michael L Terrin ◽  
Laurence S Magder ◽  
Natalie L Davis ◽  
Susan J Dulkerian ◽  
...  
Keyword(s):  
Respiratory Tract ◽  
Preterm Infants ◽  
Lower Respiratory Tract ◽  
Neonatal Intensive Care ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Double Blind ◽  
Free Survival ◽  
Mortality And Morbidity ◽  
Postmenstrual Age

ObjectiveTo test whether azithromycin eradicates Ureaplasma from the respiratory tract in preterm infants.DesignProspective, phase IIb randomised, double-blind, placebo-controlled trial.SettingSeven level III–IV US, academic, neonatal intensive care units (NICUs).PatientsInfants 240–286 weeks’ gestation (stratified 240–266; 270–286 weeks) randomly assigned within 4 days following birth from July 2013 to August 2016.InterventionsIntravenous azithromycin 20 mg/kg or an equal volume of D5W (placebo) every 24 hours for 3 days.Main outcome measuresThe primary efficacy outcome was Ureaplasma-free survival. Secondary outcomes were all-cause mortality, Ureaplasma clearance, physiological bronchopulmonary dysplasia (BPD) at 36 weeks’ postmenstrual age, comorbidities of prematurity and duration of respiratory support.ResultsOne hundred and twenty-one randomised participants (azithromycin: n=60; placebo: n=61) were included in the intent-to-treat analysis (mean gestational age 26.2±1.4 weeks). Forty-four of 121 participants (36%) were Ureaplasma positive (azithromycin: n=19; placebo: n=25). Ureaplasma-free survival was 55/60 (92% (95% CI 82% to 97%)) for azithromycin compared with 37/61 (61% (95% CI 48% to 73%)) for placebo. Mortality was similar comparing the two treatment groups (5/60 (8%) vs 6/61 (10%)). Azithromycin effectively eradicated Ureaplasma in all azithromycin-assigned colonised infants, but 21/25 (84%) Ureaplasma-colonised participants receiving placebo were culture positive at one or more follow-up timepoints. Most of the neonatal mortality and morbidity was concentrated in 21 infants with lower respiratory tract Ureaplasma colonisation. In a subgroup analysis, physiological BPD-free survival was 5/10 (50%) (95% CI 19% to 81%) among azithromycin-assigned infants with lower respiratory tract Ureaplasma colonisation versus 2/11 (18%) (95% CI 2% to 52%) in placebo-treated infants.ConclusionA 3-day azithromycin regimen effectively eradicated respiratory tract Ureaplasma colonisation in this study.Trial registration numberNCT01778634.

scholarly journals Blood pressure intervention levels in preterm infants: pilot randomised trial

2018 ◽  
Vol 104 (3) ◽  
pp. F298-F305 ◽  
Author(s):  
Sujith Stanley Pereira ◽  
Ajay Kumar Sinha ◽  
Joan Katherine Morris ◽  
David F Wertheim ◽  
Divyen K Shah ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Preterm Infants ◽  
Neonatal Intensive Care ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Treatment Guideline ◽  
Cranial Ultrasound ◽  
Clinical Complications ◽  
Extremely Preterm ◽  
Extremely Preterm Infants

ObjectiveTo examine the feasibility of a trial allocating different blood pressure (BP) intervention levels for treatment in extremely preterm infants.DesignThree-arm open randomised controlled trial performed between February 2013 and April 2015.SettingSingle tertiary level neonatal intensive care unit.PatientsInfants born <29 weeks’ gestation were eligible to participate, if parents consented and they did not have a major congenital malformation.InterventionsInfants were randomised to different levels of mean arterial BP at which they received cardiovascular support: active (<30 mm Hg), moderate (<gestational age mm Hg) or permissive (signs of poor perfusion or <19 mm Hg). Once this threshold was breached, all were managed using the same treatment guideline. BP profiles were downloaded continuously; cardiac output and carotid blood flow were measured at 1 day and 3 days, and amplitude integrated EEG was recorded during the first week. Cranial ultrasound scans were reviewed blind to study allocation.Main outcome measureInotrope usage and achieved BP.ResultsOf 134 cases screened, 60 were enrolled, with mean gestation 25.8 weeks (SD 1.5) and birth weight 817 g (SD 190). Invasively measured BP on the first day and inotrope usage were highest in the active and lowest in the permissive arms. There were no differences in haemodynamic or EEG variables or in clinical complications. Predefined cranial ultrasound findings did not differ significantly; no infants in the active arm had parenchymal brain lesions.ConclusionThe BP threshold used to trigger treatment affects the achieved BP and inotrope usage, and it was possible to explore these effects using this study design.Trial registration numberISRCTN83507686.

scholarly journals A Comparative Randomised Controlled Trial of the Effects of Brain Wave Vibration Training, Iyengar Yoga, and Mindfulness on Mood, Well-Being, and Salivary Cortisol

2012 ◽  
Vol 2012 ◽  
pp. 1-13 ◽  
Author(s):  
Deborah Bowden ◽  
Claire Gaudry ◽  
Seung Chan An ◽  
John Gruzelier
Keyword(s):  
Randomised Controlled Trial ◽  
Salivary Cortisol ◽  
Sleep Latency ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Well Being ◽  
Brain Wave ◽  
Vibration Training ◽  
Randomised Controlled ◽  
Physical Components

This randomised trial compared the effects of Brain Wave Vibration (BWV) training, which involves rhythmic yoga-like meditative exercises, with Iyengar yoga and Mindfulness. Iyengar provided a contrast for the physical components and mindfulness for the “mental” components of BWV. 35 healthy adults completed 10 75-minute classes of BWV, Iyengar, or Mindfulness over five weeks. Participants were assessed at pre- and postintervention for mood, sleep, mindfulness, absorption, health, memory, and salivary cortisol. Better overall mood and vitality followed both BWV and Iyengar training, while the BWV group alone had improved depression and sleep latency. Mindfulness produced a comparatively greater increase in absorption. All interventions improved stress and mindfulness, while no changes occurred in health, memory, or salivary cortisol. In conclusion, increased well-being followed training in all three practices, increased absorption was specific to Mindfulness, while BWV was unique in its benefits to depression and sleep latency, warranting further research.

Treatment thresholds for intervention in posthaemorrhagic ventricular dilation: a randomised controlled trial

2018 ◽  
Vol 104 (1) ◽  
pp. F70-F75 ◽  
Author(s):  
Linda S de Vries ◽  
Floris Groenendaal ◽  
Kian D Liem ◽  
Axel Heep ◽  
Annemieke J Brouwer ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Preterm Infants ◽  
Neonatal Intensive Care ◽  
Controlled Trial ◽  
Ventricular Dilatation ◽  
Shunt Revision ◽  
Neurodevelopmental Outcomes ◽  
Vp Shunt ◽  
Significant Difference ◽  
Randomised Controlled

ObjectiveTo compare a low versus a higher threshold for intervention in preterm infants with posthaemorrhagic ventricular dilatation.DesignMulticentre randomised controlled trial (ISRCTN43171322).Setting14 neonatal intensive care units in six countries.Patients126 preterm infants ≤34 weeks gestation with ventricular dilatation after grade III–IV haemorrhage were randomised to low threshold (LT) (ventricular index (VI) >p97 and anterior horn width (AHW) >6 mm) or higher threshold (HT) (VI>p97+4 mm and AHW >10 mm).InterventionCerebrospinal fluid tapping by lumbar punctures (LPs) (max 3), followed by taps from a ventricular reservoir, to reduce VI, and eventually a ventriculoperitoneal (VP) shunt if stabilisation of the VI below the p97+4 mm did not occur.Composite main outcome measureVP shunt or death.Results19 of 64 (30%) LT infants and 23 of 62 (37%) HT infants were shunted or died (P=0.45). A VP shunt was inserted in 12/64 (19%) in the LT and 14/62 (23%) infants in the HT group. 7/12 (58%) LT infants and 1/14 (7%) HT infants required shunt revision (P<0.01). 62 of 64 (97%) LT infants and 36 of 62 (58%) HT infants had LPs (P<0.001). Reservoirs were inserted in 40 of 64 (62%) LT infants and 27 of 62 (43%) HT infants (P<0.05).ConclusionsThere was no significant difference in the primary composite outcome of VP shunt placement or death in infants with posthaemorrhagic ventricular dilatation who were treated at a lower versus a higher threshold for intervention. Infants treated at the lower threshold received more invasive procedures. Assessment of neurodevelopmental outcomes will provide further important information in assessing the risks and benefits of the two treatment approaches.

scholarly journals Study design, rationale and methods of the Revitalising Informal Settlements and their Environments (RISE) study: a cluster randomised controlled trial to evaluate environmental and human health impacts of a water-sensitive intervention in informal settlements in Indonesia and Fiji

BMJ Open ◽  
2021 ◽  
Vol 11 (1) ◽  
pp. e042850
Author(s):  
Karin Leder ◽  
John J Openshaw ◽  
Pascale Allotey ◽  
Ansariadi Ansariadi ◽  
S Fiona Barker ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Human Health ◽  
Controlled Trial ◽  
Informal Settlements ◽  
Cluster Randomised Controlled Trial ◽  
Well Being ◽  
Cluster Randomised ◽  
Abundance And Diversity ◽  
Randomised Controlled ◽  
Health And Well Being

IntroductionIncreasing urban populations have led to the growth of informal settlements, with contaminated environments linked to poor human health through a range of interlinked pathways. Here, we describe the design and methods for the Revitalising Informal Settlements and their Environments (RISE) study, a transdisciplinary randomised trial evaluating impacts of an intervention to upgrade urban informal settlements in two Asia-Pacific countries.Methods and analysisRISE is a cluster randomised controlled trial among 12 settlements in Makassar, Indonesia, and 12 in Suva, Fiji. Six settlements in each country have been randomised to receive the intervention at the outset; the remainder will serve as controls and be offered intervention delivery after trial completion. The intervention involves a water-sensitive approach, delivering site-specific, modular, decentralised infrastructure primarily aimed at improving health by decreasing exposure to environmental faecal contamination. Consenting households within each informal settlement site have been enrolled, with longitudinal assessment to involve health and well-being surveys, and human and environmental sampling. Primary outcomes will be evaluated in children under 5 years of age and include prevalence and diversity of gastrointestinal pathogens, abundance and diversity of antimicrobial resistance (AMR) genes in gastrointestinal microorganisms and markers of gastrointestinal inflammation. Diverse secondary outcomes include changes in microbial contamination; abundance and diversity of pathogens and AMR genes in environmental samples; impacts on ecological biodiversity and microclimates; mosquito vector abundance; anthropometric assessments, nutrition markers and systemic inflammation in children; caregiver-reported and self-reported health symptoms and healthcare utilisation; and measures of individual and community psychological, emotional and economic well-being. The study aims to provide proof-of-concept evidence to inform policies on upgrading of informal settlements to improve environments and human health and well-being.EthicsStudy protocols have been approved by ethics boards at Monash University, Fiji National University and Hasanuddin University.Trial registration numberACTRN12618000633280; Pre-results.

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