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PubMedDate not supplied

Effects of multimicronutrient supplementation on helminth reinfection: a randomized, controlled trial in Kenyan schoolchildren.

A randomized, placebo-controlled, double-blind, two-by-two factorial trial was carried out among 977 schoolchildren from 19 primary schools in Nyanza Province, Kenya from February 1995 to February 1996. The interventions were multimicronutrient supplementation (vitamin A, 1000 micrograms; vitamin B1, 1.4 mg; vitamin B2, 1.6 mg; vitamin B6, 1.7 mg; vitamin B12, 2.0 micrograms; folate, 150 micrograms; niacin, 16 mg; vitamin C, 50 mg; vitamin D, 5 micrograms; vitamin E, 8 mg; iron, 18 mg; zinc, 20 mg; copper, 2.0 mg; iodine, 150 micrograms; selenium, 40 micrograms) and multihelminth chemotherapy (albendazole 600 mg in a single dose and/or praziquantel 40 mg/kg in a single dose). This paper reports the effects of the supplementation given on all school days on reinfection with hookworm, Ascaris lumbricoides, Trichuris trichiura and Schistosoma mansoni after 11 months. Baseline prevalence and geometric mean intensity for hookworm, A. lumbricoides, T. trichiura and S. mansoni in all children investigated were 54.7%, 13.8%, 45.6% and 70.0%, respectively and 8.6, 2.7, 5.9 and 19.4 eggs per gram (epg), respectively. Children received a mean of 2.3 multimicronutrient/placebo tablets per school week, giving a compliance rate of 46%. Children given multimicronutrients had a slightly, but significantly, lower intensity of S. mansoni reinfection compared with children given placebo (5.5 epg vs. 7.7 epg, P = 0.047). Multiple linear regression analyses controlling for baseline infection status confirmed this, as children who received micronutrients were reinfected with S. mansoni at only 69% of the intensity of those who received placebo. Multiple logistic regression analyses revealed that micronutrient supplementation was associated with a lower S. mansoni reinfection rate (odds ratio = 0.7) although this was only of borderline significance (P = 0.090). There were no significant differences in reinfection rates or intensities of hookworm, A. lumbricoides and T. trichiura. The effect on S. mansoni infection intensity is particularly interesting given the low compliance, suggesting that full micronutrient supplementation might have a role to play in S. mansoni control programmes.

Adolescent↗

PubMed1999

Developing a register for randomized controlled trials in prosthodontics: results of a search from prosthodontic journals published in the United States.

STATEMENT OF PROBLEM: Treatment decisions are often made despite absence of evidence from well-conducted clinical trials. Conclusions about treatment efficacy derived from nonexperimental approaches often overestimate treatment effect. Randomized controlled trials (RCTs) provide the most reliable basis for evaluating effectiveness of treatment interventions. PURPOSE: This study attempted to identify and catalog RCTs in prosthodontic journals published in the United States as an initial step in creating a register of clinical trials that would be a resource in setting up systemic overviews of prosthodontic literature. METHODS: The International Journal of Prosthodontics, The Journal of Prosthetic Dentistry, and The Journal of Prosthodontics published between 1988 and 1997 were searched manually to identify clinical trials. Clinical trials had to meet the following criteria for inclusion in the register: the trial must involve human subjects, must include at least 2 treatment groups, and treatment group allocation must be randomized. RESULTS: A total of 3,631 articles in 196 journal issues were screened. Sixty-two articles (1.7%) met the minimum criteria for inclusion in the RCT register. CONCLUSION: Given the lack of randomized controlled trials in prosthodontic journals, a concerted effort by the organized prosthodontic community should be made to screen national and international journals and contribute to the development of a register of randomized controlled trials relevant to prosthodontics.

Dental Research↗

PubMed2006

Prevalence and factors associated with use of placebo control groups in randomized controlled trials in psoriasis: a cross-sectional study.

BACKGROUND: The ethics and science of using placebo control groups in clinical trials have been widely debated. Few studies, however, have examined factors associated with choice of control group. OBJECTIVE: Our aim was to assess the prevalence of use of placebo controls in randomized controlled trials in psoriasis and to identify factors associated with use of placebo controls in these trials. METHODS: This is a cross-sectional study of randomized controlled trials in psoriasis published from January 1, 2001 to December 20, 2005 and indexed in the Cochrane Central Register of Controlled Trials. We extracted data on types of control groups used, design issues (number of patients enrolled, primary end point), disease characteristics (psoriasis type and severity), and extrascientific issues (trial location, funding source, and year of publication). We used bivariable and multivariable logistic regression to determine factors associated with use of a placebo control group. RESULTS: Of 194 citations, 187 were available for review. One hundred thirty-five trials from 134 articles in 38 journals met inclusion criteria. Eighty-three trials (61.5%) enrolling 8171 subjects (41.7%) used active controls only, and 52 trials (38.5%) enrolling 11,406 subjects (58.3%) used placebo controls. Adjusted for trial location and funding source, trials significantly more likely to have used placebo controls included those conducted in the United States (odds ratio [OR], 5.79; 95% confidence interval [CI], 2.45-13.68; P < .001) and those funded by pharmaceutical companies (OR, 2.61; 95% CI, 1.19-5.73; P = .02). Predicted frequencies of placebo use ranged from 77.6% (industry-funded, conducted trials in the United States) to 18.6% (non-industry-funded trials not conducted in the United States). LIMITATIONS: Our searches may not have identified all published trials, and we did not have access to data from unpublished trials. CONCLUSIONS: Use of placebo controls has been more common in psoriasis trials conducted in the United States and funded by pharmaceutical companies. The findings suggest that ethical and scientific issues related to choice of control group in psoriasis trials are interpreted markedly differently depending on trial location and funding source.

Cross-Sectional Studies↗

PubMed2002

Augmented reality guidance for needle biopsies: an initial randomized, controlled trial in phantoms.

We report the results of a randomized, controlled trial to compare the accuracy of standard ultrasound-guided needle biopsy to biopsies performed using a 3D Augmented Reality (AR) guidance system. A board-certified radiologist conducted 50 core biopsies of breast phantoms, with biopsies randomly assigned to one of the methods in blocks of five biopsies each. The raw ultrasound data from each biopsy was recorded. Another board-certified radiologist, blinded to the actual biopsy guidance mechanism, evaluated the ultrasound recordings and determined the distance of the biopsy from the ideal position. A repeated measures analysis of variance indicated that the head-mounted display method led to a statistically significantly smaller mean deviation from the desired target than did the standard display method (2.48 mm for control versus 1.62 mm for augmented reality, p<0.02). This result suggests that AR systems can offer improved accuracy over traditional biopsy guidance methods.

Biopsy, Needle↗

PubMed2001

The effect of hormone replacement therapy on serum homocysteine levels in perimenopausal women: a randomized controlled trial.

Serum homocysteine levels may be lowered by hormone replacement therapy, but randomized controlled trial data are scarce. We performed a single center randomized placebo-controlled trial to assess the 6 months effect of hormone replacement therapy compared with placebo on fasting serum homocysteine levels in 121 perimenopausal women free of cardiovascular disease, and recruited from the general population. The trial was double-blind with respect to a sequential combined regimen of oral 17 beta-estradiol and desogestrel (17 beta E(2)-D) and the placebo group and open with respect to a combination of conjugated equine estrogens and norgestrel (CEE-N). At baseline and after 6 months, fasting serum homocysteine levels were measured. Differences in 6 months serum homocysteine levels from baseline between treatment and placebo groups were calculated, and expressed as a percentage of the 6 months placebo level. After 6 months, the difference in serum homocysteine levels between women receiving 17 beta E(2)-D and placebo was -6.3% (95% CI, -12.4%; 0.0%, P=0.06). The difference between women receiving CEE-N and placebo was -10.1% (95% CI, -16.7%; -2.9%, P<0.01). The difference between the combined group of both types of hormone replacement therapy users and placebo was -7.8% (95% CI, -13.2%; -2.0%, P=0.01). No significant difference was observed between the two active regimens. Our results indicate that hormone replacement therapy decreases homocysteine levels in perimenopausal women.

Adult↗

PubMed2003

Pulse oximetry for perioperative monitoring: systematic review of randomized, controlled trials.

Monitoring with pulse oximetry might improve patient outcome by enabling an early diagnosis and, consequently, correction of perioperative events that might otherwise cause postoperative complications or even death. The aim of the study was to clarify the effect of perioperative monitoring with pulse oximetry and to identify the adverse outcomes that might be prevented or improved by its use. Trials were identified by computerized searches of the Cochrane Library, MEDLINE, EMBASE, and by checking the reference lists of trials and review articles. All controlled trials that randomized patients to either pulse oximetry or no pulse oximetry during the perioperative period, including in the operating and recovery room, were included in the study. The search identified six reports. Of these 6 reports, 4 studies with data from 21,773 patients were considered eligible for analysis. Two studies specifically addressed the outcomes in question; both found no effect on the rate of postoperative complications using perioperative pulse oximetry. Hypoxemia was reduced in the pulse oximetry group both in the operating room and in the recovery room. During observation in the recovery room, the incidence of hypoxemia in the pulse oximetry group was 1.5-3 times less. There were postoperative complications in 10% of the patients in the oximetry group and in 9.4% in the control group. The duration of hospital stay was a median of 5 days in both groups, and an equal number of in-hospital deaths was registered in both groups. The studies confirmed that pulse oximetry could detect hypoxemia and related events. However, given the relatively small number of patients studied and the rare events being sought, the studies were not able to show an improvement in various outcomes.

Blood Gas Analysis↗

PubMed2005

The quality of randomized controlled trials in major anesthesiology journals.

Increased attention has been directed at the quality of randomized controlled trials (RCTs) and how they are being reported. We examined leading anesthesiology journals to identify if there were specific areas for improvement in the design and analysis of published clinical studies. All RCTs that appeared between January 2000 and December 2000 in leading anesthesiology journals (Anesthesiology,Anesthesia & Analgesia,Anaesthesia, and Canadian Journal of Anaesthesia) were retrieved by a MEDLINE search. We used a previously validated assessment tool, including 14 items associated with study quality, to determine a quality score for each article. The overall mean weighted quality score was 44% +/- 16%. Overall average scores were relatively high for appropriate controls (77% +/- 7%) and discussions of side effects (67% +/- 6%). Scores were very low for randomization blinding (5% +/- 2%), blinding observers to results (1% +/- 1%), and post-beta estimates (16% +/- 13%). Important pretreatment clinical predictors were absent in 32% of all studies. Significant improvement in the reporting and conduct of RCTs is required and should focus on randomization methodology, the blinding of investigators, and sample size estimates. Repeat assessments of the literature may improve the adoption of guidelines for the improvement of the quality of randomized controlled trials.

Anesthesiology↗

PubMed2006

Supported employment outcomes of a randomized controlled trial of ACT and clubhouse models.

OBJECTIVE: In a randomized controlled trial, a vocationally integrated program of assertive community treatment (ACT) was compared with a certified clubhouse in the delivery of supported employment services. METHODS: Employment rates, total work hours, and earnings for 121 adults with serious mental illness interested in work were compared with published benchmark figures for exemplary supported employment programs. The two programs were then compared on service engagement, retention, and employment outcomes in regression analyses that controlled for background characteristics, program preference, and vocational service receipt. RESULTS: Outcomes for 63 ACT and 58 clubhouse participants met or exceeded most published outcomes for specialized supported employment teams. Compared with the clubhouse program, the ACT program had significantly (p<.05) better service engagement (ACT, 98 percent; clubhouse, 74 percent) and retention (ACT, 79 percent; clubhouse, 58 percent) over 24 months, but there was no significant difference in employment rates (ACT, 64 percent; clubhouse, 47 percent). Compared with ACT participants, clubhouse participants worked significantly longer (median of 199 days versus 98 days) for more total hours (median of 494 hours versus 234 hours) and earned more (median of $3,456 versus $1,252 total earnings). Better work performance by clubhouse participants was partially attributable to higher pay. CONCLUSIONS: Vocationally integrated ACT and certified clubhouses can achieve employment outcomes similar to those of exemplary supported employment teams. Certified clubhouses can effectively provide supported employment along with other rehabilitative services, and the ACT program can ensure continuous integration of supported employment with clinical care.

Adult↗

PubMed2006

Recommendations for reporting randomized controlled trials of herbal interventions: Explanation and elaboration.

Controlled trials that use randomized allocation are the best tool to control for bias and confounding in trials testing clinical interventions. Investigators must be sure to include information that is required by the reader to judge the validity and implications of the findings in the reports of these trials. In part, complete reporting of trials will allow clinicians to modify their clinical practice to reflect current evidence toward the improvement of clinical outcomes. The consolidated standards of reporting trials (CONSORT) statement was developed to assist investigators, authors, reviewers, and editors on the necessary information to be included in reports of controlled clinical trials. The CONSORT statement is applicable to any intervention, including herbal medicinal products. Controlled trials of herbal interventions do not adequately report the information suggested in CONSORT. Recently, reporting recommendations were developed in which several CONSORT items were elaborated to become relevant and complete for randomized controlled trials of herbal medicines. We expect that these recommendations will lead to more complete and accurate reporting of herbal trials. We wrote this explanatory document to outline the rationale for each recommendation and to assist authors in using them by providing the CONSORT items and the associated elaboration, together with examples of good reporting and empirical evidence, where available, for each. These recommendations for the reporting of herbal medicinal products presented here are open to revision as more evidence accumulates and critical comments are collected.

Complementary Therapies↗

PubMed2002

Randomized, controlled trial of integrated heart failure management: The Auckland Heart Failure Management Study.

AIMS: To determine the effect of an integrated heart failure management programme, involving patient and family, primary and secondary care, on quality of life and death or hospital readmissions in patients with chronic heart failure. METHODS AND RESULTS: This trial was a cluster randomized, controlled trial of integrated primary/secondary care compared with usual care for patients with heart failure. The intervention involved clinical review at a hospital-based heart failure clinic early after discharge, individual and group education sessions, a personal diary to record medication and body weight, information booklets and regular clinical follow-up alternating between the general practitioner and heart failure clinic. Follow-up was for 12 months. One hundred and ninety-seven patients admitted to Auckland Hospital with an episode of heart failure were enrolled in the study. There was no significant difference between the intervention and control groups for the combined end-point of death or hospital readmission. The physical dimension of quality of life showed a greater improvement in the intervention group from baseline to 12 months compared with the control group (-11.1 vs -5.8 respectively, 2 P=0.015). The main effect of the intervention was attributable to the prevention of multiple admissions (56 intervention group vs 95 control group, 2 P=0.015) and associated reduction in bed days. CONCLUSIONS: This integrated management programme for patients with chronic heart failure improved quality of life and reduced total hospital admissions and total bed days.

Adult↗

PubMed2002

Objective comparison of stapled anopexy and open hemorrhoidectomy: a randomized, controlled trial.

PURPOSE: This trial compares stapled anopexy with open hemorrhoidectomy in patients with prolapsing (Grade 3) hemorrhoids. Particular attention was paid to changes in anorectal physiology, nature of tissue resected, quality-of-life assessments, and cost implications of the treatments studied. METHODS: An initial pilot study was followed by a randomized, controlled trial in a District General Hospital in the United Kingdom. All patients had Grade 3 hemorrhoids. Nineteen patients were studied in the pilot study, with 99 patients in the randomized, controlled trial. All patients in the pilot study and 59 in the randomized, controlled trial underwent stapled anopexy. Thirty patients in the randomized, controlled trial underwent open hemorrhoidectomy. Of the 59 patients in the stapled group, 32 were treated with the Ethicon PPH stapling device, and 27 received stapling with a reusable Autosuture stapling device. The following variables were measured: demographic details, quality of life (Medical Outcomes Study Short Form 36 and directed questions), anorectal manometry, and histology. RESULTS: There was no difference in the case mix within or between the groups. The stapled anopexy groups showed a significant reduction in operative time (P < 0.001) and blood loss (P < 0.001) compared with open hemorrhoidectomy. Open hemorrhoidectomy resulted in significantly greater usage of protective pads postoperatively (P < 0.001) and longer rehabilitation (P < 0.006). CONCLUSIONS: Stapled anopexy is an effective alternative treatment for prolapsing hemorrhoids that allows reduced operative time and shorter rehabilitation. It does not appear to affect continence or overall quality of life.

Adult↗

PubMed2005

Sevoflurane versus halothane: postoperative maladaptive behavioral changes: a randomized, controlled trial.

BACKGROUND: The authors conducted a double-blind, randomized, controlled trial to determine whether the use of sevoflurane in children undergoing anesthesia and surgery results in a higher incidence of postoperative maladaptive behavioral changes as compared with halothane. METHODS: Children and their parents (n = 102) were randomly assigned to either a halothane group (n = 50) or a sevoflurane group (n = 52). The intraoperative anesthetic protocol was strictly controlled, and the postoperative analgesic consumption and pain levels were recorded. The effect of the group assignment on emergence status and maladaptive postoperative behavioral changes was assessed both by validated psychological measures and physiologic instruments (actigraphy) on postoperative days 1-7. Anxiety of the parent and child was also assessed, as was the child's postoperative recovery (Recovery Inventory). RESULTS: There were no group differences in preoperative state anxiety, postoperative analgesic requirements, postoperative pain, or the incidence of emergence delirium (P = not significant). Two-way repeated-measures analysis of variance showed no group differences in the incidence of postoperative maladaptive behaviors (F4,72 = 0.60, P = 0.701) or actigraphic variables such as percent sleep, number of night awakenings, and night awakenings that lasted for more than 5 min (P = not significant). CONCLUSION: The authors found no increased incidence of emergence delirium, maladaptive postoperative behavior changes, or sleep disturbances in children undergoing anesthesia with sevoflurane as compared with halothane.

Ambulatory Surgical Procedures↗

PubMed2002

Randomized controlled trial of transarterial lipiodol chemoembolization for unresectable hepatocellular carcinoma.

This randomized, controlled trial assessed the efficacy of transarterial Lipiodol (Lipiodol Ultrafluide, Laboratoire Guerbet, Aulnay-Sous-Bois, France) chemoembolization in patients with unresectable hepatocellular carcinoma. From March 1996 to October 1997, 80 out of 279 Asian patients with newly diagnosed unresectable hepatocellular carcinoma fulfilled the entry criteria and randomly were assigned to treatment with chemoembolization using a variable dose of an emulsion of cisplatin in Lipiodol and gelatin-sponge particles injected through the hepatic artery (chemoembolization group, 40 patients) or symptomatic treatment (control group, 40 patients). One patient assigned to the control group secondarily was excluded because of unrecognized systemic metastasis. Chemoembolization was repeated every 2 to 3 months unless there was evidence of contraindications or progressive disease. Survival was the main end point. The chemoembolization group received a total of 192 courses of chemoembolization with a median of 4.5 (range, 1-15) courses per patient. Chemoembolization resulted in a marked tumor response, and the actuarial survival was significantly better in the chemoembolization group (1 year, 57%; 2 years, 31%; 3 years, 26%) than in the control group (1 year, 32%; 2 years, 11%; 3 years, 3%; P =.002). When adjustments for baseline variables that were prognostic on univariate analysis were made with a multivariate Cox model, the survival benefit of chemoembolization remained significant (relative risk of death, 0.49; 95% CI, 0.29-0.81; P =.006). Although death from liver failure was more frequent in patients who received chemoembolization, the liver functions of the survivors were not significantly different. In conclusion, in Asian patients with unresectable hepatocellular carcinoma, transarterial Lipiodol chemoembolization significantly improves survival and is an effective form of treatment.

Aged↗

PubMed2002

Design and performance of a multicentre, randomized controlled trial of teleconsulting.

We have designed and performed a multicentre, randomized controlled trial of teleconsulting. The trial investigated the effectiveness and cost implications in rural and inner-city settings of using videoconferencing as an alternative to general practitioner referral to a hospital specialist. The participating general practitioners referred a total of 3170 patients who satisfied the entry criteria. Of these, 1040 (33%) failed to provide consent or otherwise refused to participate in the trial. Of the patients recruited to the trial, a total of 1902 (91%) completed and returned the baseline questionnaire. Although the trial was successful in recruiting sufficient patients and in obtaining high questionnaire response rates, the findings will require careful interpretation to take account of the limits which the protocol placed on the ability of general practitioners to select patients for referral.

Family Practice↗

PubMed2002

A prospective, randomized, controlled trial of forearm versus upper arm tourniquet tolerance.

This prospective, randomized, controlled trial studied the duration of upper and forearm tourniquet tolerance in 24 fit, healthy volunteers. Upper arm and forearm tourniquets were applied to either arm and inflated simultaneously. The time to request for deflation was recorded for each tourniquet. The mean tolerance for the upper arm tourniquet was 18 (range 10-26) min and for the forearm tourniquet was 25 (range 12-52) min. Under the conditions of this study, forearm tourniquets were tolerated for a mean of 7 min longer than upper arm tourniquets. The increase in tourniquet time afforded by a forearm tourniquet is clinically important in hand surgery performed under local anaesthetic.

Adult↗

PubMed2005

Oral retinoids for the prevention of skin cancers in solid organ transplant recipients: a systematic review of randomized controlled trials.

BACKGROUND: The increased incidence of skin cancers after solid organ transplantation is well recognized. Skin cancers developing in transplant recipients are more aggressive in behaviour. Therapeutic options to reduce and/or delay the development of cutaneous neoplasms are therefore of interest. OBJECTIVES: The objective of this review was to summarize the available medical literature from randomized controlled trials on the use of oral retinoids as a preventive agent for skin cancers in the solid organ transplant population. METHODS: Three electronic databases were searched for relevant trials: MEDLINE (1966-October 2003), EMBASE (1980-week 44, 2003) and the Cochrane Controlled Trials Register (third quarter 2003). Randomized or quasi-randomized controlled clinical trials on subjects of any age or ethnic background who had received a solid organ transplant (cardiac, renal, liver, etc.) were evaluated. All titles and abstracts found by the search strategy were independently reviewed by two researchers for inclusion into the review. RESULTS: Eighty-one abstracts were identified through the electronic databases for consideration. Review of the abstracts identified three eligible trials. One cross-over trial involving 23 subjects treated with acitretin 25 mg daily for 12 months reported 46 squamous cell carcinomas (SCCs) developing in six subjects during acitretin treatment vs. 65 SCCs developing in 15 subjects during the drug-free period. Another trial involving 44 subjects treated with acitretin 30 mg daily or placebo for 6 months reported two of 19 subjects developing two SCCs in the treatment group vs. nine of 19 subjects developing 18 new skin cancers (15 SCCs, one Bowen's disease, two basal cell carcinomas) in the placebo group. One dose comparison trial involving 26 renal transplant recipients treated with acitretin did not find a significant difference in numbers of skin cancers developing at the doses examined. The major limitation to the use of acitretin was poor tolerance due to adverse events. Headaches, rash, musculoskeletal symptoms and hyperlipidaemia were the most common causes of withdrawal from treatment. No alterations in renal or liver function were detected during the periods of treatment or follow-up. CONCLUSIONS: The available data from a small number of randomized controlled trials suggest that acitretin may have a role in the management of solid organ transplant recipients with skin cancers. Tolerability of the drug is a major factor limiting its use. Appropriate selection of patients may help improve the risk-benefit ratio.

Acitretin↗

PubMed2005

Bibliometric analysis of the literature of randomized controlled trials.

OBJECTIVE: Evidence-based medicine (EBM) is a significant issue and the randomized controlled trial (RCT) literature plays a fundamental role in developing EBM. This study investigates the features of RCT literature based on bibliometric methods. Growth of the literature, publication types, languages, publication countries, and research subjects are addressed. The distribution of journal articles was also examined utilizing Bradford's law and Bradford-Zipf's law. METHOD: The MEDLINE database was searched for articles indexed under the publication type "Randomized Control Trial," and articles retrieved were counted and analyzed using Microsoft Access, Microsoft Excel, and PERL. RESULTS: From 1990 to 2001, a total of 114,850 citations dealing with RCTs were retrieved. The literature growth rate, from 1965 to 2001, is steadily rising and follows an exponential model. Journal articles are the predominant form of publication, and the multicenter study is extensively used. English is the most commonly used language. CONCLUSIONS: Generally, RCTs are found in publications concentrating on cardiovascular disease, cancer, asthma, postoperative condition, health, and anesthetics. Zone analysis and graphical formulation from Bradford's law of scattering shows variations from the standard Bradford model. Forty-two core journals were identified using Bradford's law.

Bibliometrics↗

PubMed2026

Impact of kangaroo care on circadian rhythm, growth, physiological stability in premature infants, and cortisol and melatonin levels in maternal breast milk: A randomized controlled trial.

PURPOSE: This study aimed to examine the effects of regular kangaroo care (KC) on sleep-wake cycles, growth, physiological stability, and maternal breast milk cortisol and melatonin levels in premature infants. DESIGN: This study was a parallel group, single-blind, pre-test-post-test, randomised controlled trial (RCT). METHODS: This randomized controlled study was conducted in a neonatal intensive care unit (NICU) in Türkiye between September 2024 and September 2025 Thirty-six premature infants were randomized to intervention (n = 28) or control (n = 28). Infants in the intervention group received KC for three consecutive days, twice daily (10:00 a.m. and 10:00 p.m.) for 60 min per session. Data were collected using the Infant Information Form, Physiological Parameters Monitoring Chart, and Premature Infant Sleep-Wake Cycles Tracking Chart. Sleep-wake cycles were monitored using a Bispectral Index device. Breast milk cortisol and melatonin levels were measured at baseline and on day three using the competitive ELISA method. The study was registered at ClinicalTrials.gov (NCT06589349). RESULTS: Regular KC had a statistically significant effect on BIS values, heart rate, respiratory rate, oxygen saturation, and body temperature (p < 0.05). No statistically significant effects were observed on infant body weight or on maternal breast milk cortisol and melatonin levels (p > 0.05). CONCLUSION: The findings indicate that regular KC is associated with improved regulation of the sleep-wake cycle and enhanced physiological stability in premature infants. No significant changes were observed in maternal breast milk cortisol or melatonin levels following KC.

Humans↗