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At least 955 records · Page 53Linked to original sources
PubMed2001

Exercise combined with continuous passive motion or slider board therapy compared with exercise only: a randomized controlled trial of patients following total knee arthroplasty.

BACKGROUND AND PURPOSE: The primary purpose of this randomized controlled trial was to determine which method of mobilization - (1) standardized exercises (SE) and continuous passive motion (CPM), (2) SE and slider board (SB) therapy, using an inexpensive, nontechnical device that requires minimal knee active range of motion (ROM), or (3) SE alone-achieved the maximum degree of knee ROM in the fIrst 6 months following primary total knee arthroplasty (TKA). The secondary purpose was to compare health-related quality of life among these 3 groups. SUBJECTS: The subjects were 120 patients (n=40/group) who received a TEA at a teaching hospital between June 1997 and July 1998 and who agreed to participate in the study. METHODS: Subjects were examined preoperatively, at discharge, and at 3 and 6 months after surgery. The examination consisted of measurement of knee ROM and completion of the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index and the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36). RESULTS: The 3 treatment groups were similar with respect to age, sex, and diagnosis at the start of the study. There were no differences in knee ROM or in WOMAC Osteoarthritis Index or SF-36 scores at any of the measurement intervals. The rate of postoperative complications also was not different among the groups. DISCUSSION AND CONCLUSION: When postoperative rehabilitation regimens that focus on early mobilization of the patient are used, adjunct ROM therapies (CPM and SB) that are added to daily SE sessions are not required. Six months after TEA, patients attain a satisfactory level of knee ROM and function.

Activities of Daily Living↗
PubMed2006

Methods of blinding in reports of randomized controlled trials assessing pharmacologic treatments: a systematic review.

BACKGROUND: Blinding is a cornerstone of therapeutic evaluation because lack of blinding can bias treatment effect estimates. An inventory of the blinding methods would help trialists conduct high-quality clinical trials and readers appraise the quality of results of published trials. We aimed to systematically classify and describe methods to establish and maintain blinding of patients and health care providers and methods to obtain blinding of outcome assessors in randomized controlled trials of pharmacologic treatments. METHODS AND FINDINGS: We undertook a systematic review of all reports of randomized controlled trials assessing pharmacologic treatments with blinding published in 2004 in high impact-factor journals from Medline and the Cochrane Methodology Register. We used a standardized data collection form to extract data. The blinding methods were classified according to whether they primarily (1) established blinding of patients or health care providers, (2) maintained the blinding of patients or health care providers, and (3) obtained blinding of assessors of the main outcomes. We identified 819 articles, with 472 (58%) describing the method of blinding. Methods to establish blinding of patients and/or health care providers concerned mainly treatments provided in identical form, specific methods to mask some characteristics of the treatments (e.g., added flavor or opaque coverage), or use of double dummy procedures or simulation of an injection. Methods to avoid unblinding of patients and/or health care providers involved use of active placebo, centralized assessment of side effects, patients informed only in part about the potential side effects of each treatment, centralized adapted dosage, or provision of sham results of complementary investigations. The methods reported for blinding outcome assessors mainly relied on a centralized assessment of complementary investigations, clinical examination (i.e., use of video, audiotape, or photography), or adjudication of clinical events. CONCLUSIONS: This review classifies blinding methods and provides a detailed description of methods that could help trialists overcome some barriers to blinding in clinical trials and readers interpret the quality of pharmacologic trials.

Double-Blind Method↗
PubMed1984

Primary prevention of hypertension--a randomized controlled trial.

Nutritional-hygienic intervention is a key strategy in the control of hypertension through primary prevention. To test the efficacy of this approach, 201 men and women were selected to participate in a randomized controlled trial on the primary prevention of hypertension. Individuals were taken into the trial if their diastolic blood pressure at entry was 80-89 mm Hg with either relative weight 1.10-1.49 or heart rate of 80 or greater. Half of the eligible persons were randomized into the monitored group and half were randomized into the intervention group receiving individual intervention to achieve a weight loss of 10 or more lbs (greater than or equal to 4.5 kg), to reduce Na intake to 75 mmol (1800 mg), to limit alcohol intake to no more than 2 drinks per day (26 g) and to engage in regular moderate physical activity. At two years, the 75 participants of the intervention group showed a mean weight loss of 5.2 lbs. among those initially overweight, a mean reduction in Na intake of 44% of goal and a moderate reduction of alcohol intake. Self-reported exercise had also increased and was reflected in the larger decrease in mean heart rate compared with the monitored group. Diastolic blood pressure was only slightly lower among the intervention group compared to the monitored group, but was an additional 4.0 mm Hg lower among those intervention participants achieving weight loss and reduction in Na intake greater than the median for the group. In addition, at two years, a rise in diastolic blood pressure sufficient to require antihypertensive medication occurred in 5 participants of the control group compared to 0 of the intervention group. At three years, 11 monitored and 3 intervention group participants required antihypertensive medication.

Adult↗
PubMed2001

Child health status, neurodevelopmental outcome, and parental satisfaction in a randomized, controlled trial of nitric oxide for persistent pulmonary hypertension of the newborn.

OBJECTIVE: To describe health and neurodevelopmental outcomes and parental satisfaction with hospital care among surviving intervention and control enrollees in a randomized, controlled trial of nitric oxide for persistent pulmonary hypertension of the newborn (PPHN). METHODS: All surviving enrollees 1 to 4 years of age were eligible for follow-up. Outcomes were assessed by telephone using a trained interviewer and standardized instruments. Domains assessed included parental report of specific conditions and hospital use, rating of general health, cognitive and motor development, behavior problems, temperament, and satisfaction with the hospital stay. Fisher's exact test and the Wilcoxon rank sum test assessed differences between intervention and control infants. RESULTS: Interviews were completed on 60 of 83 survivors (72%). Eighteen families (22%) could not be located, 2 (2%) were non-English-speaking, and 3 (4%) declined participation. No postdischarge deaths were ascertained. Among those interviewed, race, income, and education of parents of intervention and controls were comparable, as were entry oxygenation index, extracorporeal oxygenation utilization, and days of hospitalization. No differences were found in pulmonary, neurologic, cognitive, behavioral, or neurosensory outcomes; hospital readmission rates; or parental ratings of child's health. The overall neurologic handicap rate was 15%. The rate of hearing deficit was 7%. The rate of significant behavioral problems was 26%. Levels of satisfaction expressed were high for each group. No differences in parental ratings were found between the 2 groups. CONCLUSIONS: No adverse health or neurodevelopmental outcomes have been observed among infants treated with nitric oxide for PPHN. The parents of the critically ill infants enrolled in our clinical trial welcomed their child's inclusion and all expressed satisfaction with the care that their child received while at a tertiary care hospital. Enrollment in either arm of this randomized, controlled trial did not seem to affect parental satisfaction with the hospital care that their child received.

Adult↗
PubMed2003

Implementation and quantitative evaluation of chronic disease self-management programme in Shanghai, China: randomized controlled trial.

OBJECTIVE: To evaluate the effectiveness of the Shanghai Chronic Disease Self-Management Program (CDSMP). METHODS: A randomized controlled trial with six-month follow-up compared patients who received treatment with those who did not receive treatment (waiting-list controls) in five urban communities in Shanghai, China. Participants in the treatment group received education from a lay-led CDSMP course and one copy of a help book immediately; those in the control group received the same education and book six months later. FINDINGS: In total, 954 volunteer patients with a medical record that confirmed a diagnosis of hypertension, heart disease, chronic lung disease, arthritis, stroke, or diabetes who lived in communities were assigned randomly to treatment (n = 526) and control (n = 428) groups. Overall, 430 (81.7%) and 349 (81.5%) patients in the treatment and control groups completed the six-month study. Patients who received treatment had significant improvements in weekly minutes of aerobic exercise, practice of cognitive symptom management, self-efficacy to manage own symptoms, and self-efficacy to manage own disease in general compared with controls. They also had significant improvements in eight indices of health status and, on average, fewer hospitalizations. CONCLUSION: When implemented in Shanghai, the CDSMP was acceptable culturally to Chinese patients. The programme improved participants' health behaviour, self-efficacy, and health status and reduced the number of hospitalizations six months after the course. The locally based delivery model was integrated into the routine of community government organizations and community health services. Chinese lay leaders taught the CDSMP courses as successfully as professionals.

Aged↗
PubMedDate not supplied

Efficacy of artesunate plus chloroquine for uncomplicated malaria in children in Sao Tome and Principe: a double-blind, randomized, controlled trial.

We conducted a double-blind, randomized, placebo-controlled trial in Sao Tome and Principe to investigate the safety, tolerability and efficacy of chloroquine (CQ) combined with artesunate (AS) over CQ monotherapy. Four hundred children, aged 6-59 months, with acute uncomplicated Plasmodium falciparum malaria were randomized to receive a standard dose of CQ (25 mg/kg bodyweight) over 3 d or CQ + AS (4 mg/kg bodyweight) daily for 3 d. Children were followed-up for 28 d. The combined treatment was well tolerated and there were no serious drug-related adverse events. By day 2 parasite clearance was significantly faster for children treated with CQ + AS compared with CQ alone (29/194 [14.9%] vs. 168/190 [88.4%] still parasitaemic, P< 0.0001). Day 14 parasitological failure rates were 153/191 (80.1%) for CQ alone compared with 32/193 (16.6%) in the CQ + AS group (odds ratio [OR] =20.2, 95% CI 11.7-35.4, P< 0.001). Corresponding clinical failure rates were 128/161 (67.0%) and 12/193 (6.2%) (OR = 30.6, 95% CI 15.3-62.7, P< 0.001). By day 28 the parasitological failure rates (new infections excluded) were 155/191 (81.1%) in the CQ group and 63/194 (32.4%) in the CQ + AS group (OR = 8.9, 95% CI 5.4-14.7, P< 0.001). Symptoms resolved faster in children who received AS. They were also less likely to be gametocytaemic after treatment. The combination treatment was well tolerated and considerably improved treatment efficacy. However, the current levels of CQ resistance preclude its use in Sao Tome where CQ should be abandoned as first-line drug. However, CQ + AS may be an option in areas where CQ resistance is lower.

Acute Disease↗
PubMed2004

A randomized controlled trial of league tables and control charts as aids to health service decision-making.

OBJECTIVES: Health service managers and other decision-makers are required to act on the basis of data. Little attention has been paid to the effects of data presentation on the decisions taken. This study uses a randomized controlled trial design to investigate the effects of two forms of data presentation--league tables and control charts--on health service decision-makers. METHODS: Directors of public health in 122 health authorities in the UK were mailed three case studies and a questionnaire. The case studies showed data on variations in mortality by health service provider. The questionnaire asked them to indicate whether they would take action as a result of the data and to identify the health service providers on whom they would take action. Participants were randomly allocated to receive the same data in the form of ranked histograms (league tables) or control charts. MAIN OUTCOME MEASURE: The percentage of participants who would take action on health service providers. RESULTS: Fifty-seven questionnaires were returned. For each case study, respondents receiving data as league tables stated they would take action on significantly more health service providers than those receiving data as control charts: for the first case study, the percentages were 3.3% versus 1.8% (P < 0.001) for league tables and control charts, respectively; for the second case study, 15.9% versus 6.7% (P = 0.029), respectively; and for the third, 5.9% versus 0.7% (P = 0.002), respectively. Respondents receiving data as league tables were significantly more likely to request further information on case mix. CONCLUSIONS: Compared with league tables, health service decision-makers identify fewer outliers for further action when performance data are presented as control charts. They also reduce the tendency to request further information. Using control charts rather than league tables for the routine presentation of comparative data would reduce over-investigation of unusual performance.

Bias↗
PubMed2000

Effectiveness of massage therapy for subacute low-back pain: a randomized controlled trial.

BACKGROUND: The effectiveness of massage therapy for low-back pain has not been documented. This randomized controlled trial compared comprehensive massage therapy (soft-tissue manipulation, remedial exercise and posture education), 2 components of massage therapy and placebo in the treatment of subacute (between 1 week and 8 months) low-back pain. METHODS: Subjects with subacute low-back pain were randomly assigned to 1 of 4 groups: comprehensive massage therapy (n = 25), soft-tissue manipulation only (n = 25), remedial exercise with posture education only (n = 22) or a placebo of sham laser therapy (n = 26). Each subject received 6 treatments within approximately 1 month. Outcome measures obtained at baseline, after treatment and at 1-month follow-up consisted of the Roland Disability Questionnaire (RDQ), the McGill Pain Questionnaire (PPI and PRI), the State Anxiety Index and the Modified Schober test (lumbar range of motion). RESULTS: Of the 107 subjects who passed screening, 98 (92%) completed post-treatment tests and 91 (85%) completed follow-up tests. Statistically significant differences were noted after treatment and at follow-up. The comprehensive massage therapy group had improved function (mean RDQ score 1.54 v. 2.86-6.5, p < 0.001), less intense pain (mean PPI score 0.42 v. 1.18-1.75, p < 0.001) and a decrease in the quality of pain (mean PRI score 2.29 v. 4.55-7.71, p = 0.006) compared with the other 3 groups. Clinical significance was evident for the comprehensive massage therapy group and the soft-tissue manipulation group on the measure of function. At 1-month follow-up 63% of subjects in the comprehensive massage therapy group reported no pain as compared with 27% of the soft-tissue manipulation group, 14% of the remedial exercise group and 0% of the sham laser therapy group. INTERPRETATION: Patients with subacute low-back pain were shown to benefit from massage therapy, as regulated by the College of Massage Therapists of Ontario and delivered by experienced massage therapists.

Adult↗
PubMed2004

Fall prevention in residential care: a cluster, randomized, controlled trial.

OBJECTIVES: To establish the effectiveness of a fall-prevention program in reducing falls and injurious falls in older residential care residents. DESIGN: Cluster, randomized, controlled trial. SETTING: Fourteen randomly selected residential care homes in Auckland, New Zealand. PARTICIPANTS: All older residents (n=628, 95% participation rate). INTERVENTION: Residential care staff, using existing resources, implemented systematic individualized fall-risk management for all residents using a fall-risk assessment tool, high-risk logo, and strategies to address identified risks. MEASUREMENTS: Number of residents sustaining a fall, falls, and injurious-falls incidence rates. RESULTS: During 12 months of follow-up, 103 (43%) residents in the control group and 173 (56%) residents in the intervention group fell (P<.018). There was a significantly higher incidence rate of falls in intervention homes than in control homes (incident rate ratio=1.34, 95% confidence interval=1.06-1.72) during the intervention period after adjusting for dependency level (type of home), baseline fall rate, and clustering. There was no difference in the injurious fall incidence rate or incidence of serious injuries. CONCLUSION: This fall-prevention intervention did not reduce falls or injury from falls. Low-intensity intervention may be worse than usual care.

Accident Prevention↗
PubMed2002

Early discharge and home rehabilitation after hip fracture achieves functional improvements: a randomized controlled trial.

OBJECTIVE: To compare hospital and home settings for the rehabilitation of patients following hip fracture. DESIGN: Randomized controlled trial comparing accelerated discharge and home-based rehabilitation (n = 34) with conventional hospital care (n = 32) for patients admitted to hospital with hip fracture. SETTING: Three metropolitan hospitals in Adelaide, Australia. SUBJECTS: Sixty-six patients with fractured hip. INTERVENTIONS: Patients assigned to the home-based rehabilitation group were discharged within 48 hours of randomization. The project team therapists made visits to the patient's home and negotiated a set of realistic, short-term and measurable treatment goals with both the patient and carer. Those randomized to usual care remained in hospital for conventional rehabilitation. MAIN OUTCOME MEASURES: Physical and social dependence, balance confidence, quality of life, carer strain, patient and carer satisfaction, use of community services and incidence of adverse events such as re-admission and falls. RESULTS: While there was no difference between the groups for all measures of quality of life, patients in the accelerated discharge and home-based rehabilitation group recorded a greater improvement in MBI from randomization (p < 0.05) and scored higher on the Falls Efficacy Scale (p < 0.05) at four months. There was no difference in falls rates. Patients in the home-based rehabilitation group had a shorter stay in hospital (p < 0.05) but a longer stay in rehabilitation overall (p < 0.001). The groups were comparable on the rate and length of admissions after discharge, use of community services, need for carer input and contact with general practitioner (GP) after discharge. CONCLUSIONS: This trial further supports the practice of accelerated discharge from hospital and home-based rehabilitation in selected patients recovering from hip fracture. Such a practice appears to improve physical independence and confidence in avoiding subsequent falls which may have implications for longevity and overall quality of life.

Aged↗
PubMed2005

Efficacy of an educational programme for secondary school students on opinions on renal transplantation and organ donation: a randomized controlled trial.

CONTEXT: Organ shortage for transplantation is a crucial problem; educational interventions may increase donations and decrease opposition. OBJECTIVE: To test the efficacy of an educational programme on opinions on organ transplantation and kidney donation. DESIGN AND PARTICIPANTS: Cluster Randomized Controlled Trial: eight intervention and eight control schools were randomly selected from the 33 public schools that agreed to participate. Targets: students in the last 2 years of secondary school (17-18 years); seven schools per group completed the study. EDUCATIONAL PROGRAMME: INTERVENTION: first questionnaire (anonymous); 2 h lesson in each class; 2 h general session with patients and experts; second questionnaire. CONTROL: questionnaires. MAIN OUTCOME MEASURES: Differences between questionnaires (comparative analysis); interest; satisfaction with the programme; (cross-sectional analysis). RESULTS: 1776 first, 1467 second questionnaires were retrieved. Living kidney donation: at baseline 78.8% of students would donate a kidney to a relative/friend in need. The answers were unaffected by type of school but depended on sex (females more prone to donate, P<0.001); the answers did not change after the lessons. Cadaveric kidney donation: baseline opinions were mixed (intervention schools: 31.5% yes, 33.7% no, 34.8% uncertain), depending on type of school (classical-scientific high schools more positive than technical institutes, P<0.001), sex (males more prone to donate, P<0.001). Answers on living and cadaveric donation were correlated (P<0.001). The educational intervention increased favourable (31.5 to 42.9%) and uncertain (34.8 to 41.1%) opinions and decreased negative ones (33.7 to 16%) (P<0.001). CONCLUSIONS: Educational interventions are effective in increasing interest and improving opinions about cadaveric organ donation.

Adolescent↗
PubMed2005

[A controlled randomized trial of the use of combined L-carnitine and acetyl-L-carnitine treatment in men with oligoasthenozoospermia].

OBJECTIVE: To determine the efficacy and safety of combined L-carnitine and acetyl-L-carnitine therapy in infertile males with oligoasthenozoospermia. METHODS: One hundred fifty patients with oligoasthenozoospermia were randomized selected into treatment and control groups. The treatment group with 90 patients were given L-carnitine (2 g/d) and acetyl-L-carnitine (1 g/d) orally, twice a day. The patients in control group were given Vitamin E 100 mg plus Vitamin C 100 mg, tid. The oral therapy lasted three months and patients accepted sperm analysis every one month. The L-carnitine level in seminal plasma was examined by high performance liquid chromatography (HPC). Side effects as well as pregnant rate were observed. RESULTS: In the treatment group, 85 patients out of 90 finished the three month treatment. Female spouses of 10 patients (11.6%) achieved pregnancy. Moreover, their forward motile sperm per ejaculation, total motile sperm, as well as the concentration of L-carnitine in seminal plasma were increased significantly (P < 0.01). In control group, 53 patients out of 60 completed three months therapy. Two pregnancy (3.7%) was observed. Though some increase was seen in number of forward motile sperm and total motile sperm per ejaculation, the changes were not statistically significant (P > 0.05). The difference of the pregnant rate between two groups was statistically significant. No side effects were found. CONCLUSION: Combined treatment with L-carnitine and acetyl-L-calmitine can be an effective and safe option for treating oligoasthenozoospermia by means of significantly improving forward motile sperm and total motile sperm per ejaculation, as well as increasing pregnant rates.

Acetylcarnitine↗
PubMed1998

[Is the randomized controlled trial overvalued as a basis for clinical decision-making? A review with comments].

The randomized controlled trial (RCT) may have considerable limitations in clinical research. Lacking the possibility of blinding impairs the internal validity of the trials. The external validity is often impaired, as results of RCTs obtained in an ideal situation, may be difficult to generalize to a clinical routine situation. Pragmatic randomized trials move from ideal situations towards routine situations, and by modifying the design it is possible to reduce selection bias due to patient and physician preferences. Quasi-experimental studies have varying degrees of problems with internal validity but are necessary contributions to our knowledge of the effect of treatment in clinical routine situations. Limitations of the usefulness of RCTs as well as pragmatic and quasi-experimental studies in clinical research make it necessary to recognise that different methods complement one another. Research in development of RCTs and new methods in clinical research should be encouraged.

Decision Making↗
PubMed1978

Randomized controlled trial of Syn-Ergel and an active placebo in the treatment of heartburn of pregnancy.

A randomized controlled trial was performed to study the efficacy of Syn-Ergel with an active placebo in the treatment of heartburn of pregnancy in ninety-two patients completing 7 days of therapy. Syn-Ergel was significantly better (p less than 0.001) in all groups of pre-treatment pain severity in relieving the symptoms, and had a longer duration of action, than the active placebo. Complete relief of pain was achieved in 79.5% of Syn-Ergel treatments with a further 10% of treatments resulting in marked easing of discomfort at 1 hour following administration. The corresponding figures for the 'active placebo' were 56% and 20%. The combination of an antacid and a protective mucosal coating agent would appear to be a useful approach in the treatment of heartburn of pregnacy.

Agar↗
PubMed2001

Multisite randomized controlled trials in health services research: scientific challenges and operational issues.

Although well-designed randomized controlled trials (RCT) provide the strongest evidence regarding causation, only relatively recently have they been used by health services researchers to study the organization, delivery, quality, and outcomes of care. More recent yet is the extension of multisite RCTs to health services research. Such studies offer numerous methodological advantages over single-site trials: (1) enhanced external validity; (2) greater statistical power when studying conditions with a low incidence or prevalence, small event rate in the outcome (eg, mortality), and/or large variance in the outcome (eg, health care costs); and (3) rapid recruitment to provide health care organizations and policy makers with timely results. This paper begins by outlining the advantages of multisite RCTs over single-site trials. It then discusses both scientific challenges (ie, standardizing eligibility criteria, defining and standardizing the intervention, defining usual care, standardizing the data collection protocol, blinded outcome assessment, data management and analysis, measuring health care costs) and operational issues (ie, site selection, randomization procedures, patient accrual, maintaining enthusiasm, oversight) posed by multisite RCTs in health services research. Recommendations are offered to health services researchers interested in conducting such studies.

Cost Control↗
PubMed1997

A systematic review of randomized controlled trials of pharmacological therapy in osteoarthritis of the hip.

OBJECTIVE: To systematically review all randomized controlled trials (RCT) of pharmacological therapy in osteoarthritis (OA) of the hip. To determine which nonsteroidal antiinflammatory drug (NSAID) is the most effective, and which NSAID is the most toxic. METHODS: A MEDLINE search was used to identify RCT of pharmacological therapy in patients with OA of the hip published between 1966 and August 1994. Qualitative assessments were performed using a quality scoring system designed for NSAID trials in rheumatoid arthritis. Both the design and analysis aspects of the trials were evaluated, each aspect rated on a scale of 0 to 8. A quantitative method, which calculates the ratio of improvement produced by one NSAID to that produced by another, was used to rate the relative efficacy of different NSAID with respect to pain relief. Toxicity comparisons were made according to the authors' findings. RESULTS: 43 RCT were identified, and of these, 39 evaluated NSAID while 4 evaluated only analgesics. The median design and analysis scores were 2 and 4, respectively, 6 NSAID were included in at least 5 trials; of these, indomethacin was rated more effective in 5 of its 7 comparisons, but more toxic in 7 of 12 comparisons. Only 5 of the 29 (17%) NSAID comparisons found statistically significant differences in efficacy. CONCLUSION: NSAID trials in patients with OA of the hip appear to be weakened by the lack of standardization of case definition of OA, and also by the lack of standardization of outcome assessments. No recommendations for the choice of specific NSAID therapy in hip OA can be offered based on this analysis.

Anti-Inflammatory Agents, Non-Steroidal↗
PubMed2005

A randomized controlled trial of enteral glutamine supplementation in very low birth weight infants: plasma amino acid concentrations.

OBJECTIVE: Glutamine depletion has negative effects on the functional integrity of the gut and leads to immunosuppression. Very low birth weight (VLBW) infants are susceptible to glutamine depletion, as enteral nutrition is limited in the first weeks of life. Enteral glutamine supplementation may have a positive effect on feeding tolerance, infectious morbidity and short-term outcome. The aim of the study was to determine the effect of enteral glutamine supplementation on plasma amino acid concentrations, reflecting one aspect of safety of enteral glutamine supplementation in VLBW infants. METHODS: In a double-blind placebo-controlled randomized controlled trial, VLBW infants (gestational age <32 weeks or birth weight <1500 g) received enteral glutamine supplementation (0.3 g/kg per day) or isonitrogenous placebo supplementation (alanine) between day 3 and day 30 of life. Supplementation was added to breast milk or to preterm formula. Plasma amino acid concentrations were measured at four time points: before the start of the study and at days 7, 14 and 30 of life. RESULTS: Baseline patient and nutritional characteristics were not different in glutamine (n = 52) and control (n = 50) groups. Plasma concentrations of most essential and non-essential amino acids increased throughout the study period. There was no effect of enteral glutamine supplementation. In particular, the increase of plasma glutamine and glutamate concentrations was not different between the treatment groups (P = 0.49 and P = 0.34 respectively, day 30). CONCLUSIONS: Enteral glutamine supplementation in VLBW infants does not alter plasma concentrations of glutamine, glutamate or other amino acids. Enteral supplementation in a dose of 0.3 g/kg per day seems safe in VLBW infants.

Amino Acids↗