Browsing by Item Type "Clinical Trial"
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Clinical Trial Associations of maternal iron deficiency with malaria infection in a cohort of pregnant Papua New Guinean women.(2022-05-26); ;Bleicher, Andie ;Ome-Kaius, Maria ;Aitken, Elizabeth HRogerson, Stephen JBACKGROUND: Iron deficiency (ID) is common in malaria-endemic settings. Intermittent preventative treatment of malaria in pregnancy (IPTp) and iron supplementation are core components of antenatal care in endemic regions to prevent adverse pregnancy outcomes. ID has been associated with reduced risk of malaria infection, and correspondingly, iron supplementation with increased risk of malaria infection, in some studies. METHODS: A secondary analysis was conducted amongst 1888 pregnant women enrolled in a malaria prevention trial in Papua New Guinea. Maternal ID was defined as inflammation-corrected plasma ferritin levels < 15 μg/L at antenatal enrolment. Malaria burden (Plasmodium falciparum, Plasmodium vivax) was determined by light microscopy, polymerase chain reaction, and placental histology. Multiple logistic and linear regression analyses explored the relationship of ID or ferritin levels with indicators of malaria infection. Models were fitted with interaction terms to assess for modification of iron-malaria relationships by gravidity or treatment arm. RESULTS: Two-thirds (n = 1226) and 13.7% (n = 258) of women had ID and peripheral parasitaemia, respectively, at antenatal enrolment (median gestational age: 22 weeks), and 18.7% (120/1,356) had evidence of malaria infection on placental histology. Overall, ID was associated with reduced odds of peripheral parasitaemia at enrolment (adjusted odds ratio [aOR] 0.50; 95% confidence interval [95% CI] 0.38, 0.66, P < 0.001); peripheral parasitaemia at delivery (aOR 0.68, 95% CI 0.46, 1.00; P = 0.050); and past placental infection (aOR 0.35, 95% CI 0.24, 0.50; P < 0.001). Corresponding increases in the odds of infection were observed with two-fold increases in ferritin levels. There was effect modification of iron-malaria relationships by gravidity. At delivery, ID was associated with reduced odds of peripheral parasitaemia amongst primigravid (AOR 0.44, 95% CI 0.25, 0.76; P = 0.003), but not multigravid women (AOR 1.12, 95% CI 0.61, 2.05; P = 0.720). A two-fold increase in ferritin associated with increased odds of placental blood infection (1.44, 95% CI 1.06, 1.96; P = 0.019) and active placental infection on histology amongst primigravid women only (1.24, 95% CI 1.00, 1.54; P = 0.052). CONCLUSIONS: Low maternal ferritin at first antenatal visit was associated with a lower risk of malaria infection during pregnancy, most notably in primigravid women. The mechanisms by which maternal iron stores influence susceptibility to infection with Plasmodium species require further investigation.3320 - Publication
Clinical Trial Milk formulas in acute gastroenteritis and malnutrition: a randomized trial.(2002-12) ;Kukuruzovic, R HBrewster, D RTo compare three low-lactose milk formulas differing in osmolality and degree of protein hydrolysis in the treatment of diarrhoea and malnutrition in subjects with high rates of lactose intolerance, osmotic diarrhoea and a tropical/environmental enteropathy. A randomized double-blind trial of 180 Aboriginal children under 3 years of age admitted with acute diarrhoea and/or malnutrition was carried out. The intervention milk formulas were: (i) De-Lact, a low-osmolality lactose-free formula; (ii) O-Lac, a lactose-free formula; and (iii) Alfaré, a partially hydrolysed formula. Outcome measures were diarrhoeal severity, weight gain, formula palatability and changes in intestinal permeability (L/R ratios). The duration of diarrhoea in days (mean; 95% confidence interval) was significantly longer on Alfaré (8.5; 7.0-10.0) compared to De-Lact (6.1; 5.0-7.2) and O-Lac (6.9; 5.6-8.1; P = 0.04). There were no differences in mean intake between formulas, but palatability of Alfaré was significantly worse (P < 0.01) than the other formulas. Over the trial 5 days, improvement in L/R ratios was significantly greater (P = 0.05) for De-Lact (18.6; 10.6-26.6) than for Alfaré (8.5; 2.1-14.9). Weight gain was not significantly different between the three formulas, except in a malnourished subgroup who had better weight gain on De-Lact (P = 0.05). In these Aboriginal children with diarrhoea and growth failure, a low osmolality milk was associated with better outcomes and a partially hydrolysed formula with less improvement in mucosal recovery, suggesting that cow's milk protein intolerance is not contributing to greater diarrhoeal severity or enteropathy in Aboriginal children.1201 - Publication
Clinical Trial Open versus closed surgical treatment of abscesses: a controlled clinical trial.(1997-04) ;Abraham, N ;Doudle, MCarson, PConventional drainage, curettage and packing of acute superficial abscesses has been challenged and in some centres replaced by curettage and primary closure under antibiotic cover. This technique has not been used widely in Australasia or North America, probably because of the lack of reassurance from local randomized trials. A randomized trial was conducted to compare the primary closure of acute superficial abscesses to conventional packing. Abscesses requiring drainage under a general anaesthetic were considered for the study, excluding extensive, secondary and deep suppurations. In the 'open' group, the abscess was drained, curetted, irrigated, and then packed. Instead of packing, the cavity in the 'closed' group was obliterated using interrupted vertical mattress skin sutures with/without closed suction drainage. Other aspects of management were standardized. Of the 32 abscesses treated using the closed technique, 25 (78%) healed by primary intention after 1 week (SE(p) = 7.3%; 95% CI = 63.7-92.4%). One of the 29 abscesses (3%) treated using the open technique healed by secondary intention in a similar period of time. The difference was statistically significant (Chi-squared test with Yates' continuity correction = 31.70; P < 0.0001). There was no statistically significant difference in the overall incidence of healing, 1 month after surgery (chi 1(2) = 0.07; P > 0.9). In the closed group, healing was obtained by primary intention, leaving a linear surgical scar in 84% of the cases (SE(p) = 5.7%; 95% CI = 72.8-95.2%). Hospitalization and the need for analgesia and dressing changes were reduced by 40-60%. Primary closure of acute superficial abscesses was associated with an improved outcome in terms of duration and quality of healing, postoperative pain, length of hospitalization, nursing care and, by implication, cost, and may be recommended as an alternative treatment that is superior to the orthodox technique.1252 - Publication
Clinical Trial Pain relief following day case laparoscopic tubal ligation with intra-peritoneal ropivacaine: a randomised double blind control study.(2000-11) ;Dreher, J K ;Nemeth, DLimb, RThe aim of this study was to examine the effectiveness of ropivacaine administered by a simple intraperitoneal technique in relieving pain following laparoscopic application of Filshie clips. Nineteen patients were randomised to receive either ropivacaine (200 mg) or normal saline through the umbilical port following clip application. Using a visual analogue scale women receiving ropivacaine had significantly lower pain scores 2 hours post operatively (0.97 vs 2.03 p < 0.05). The mean total postoperative fentanyl use was also significantly lower on the ropivacaine group (40 microg vs 104 microg p < 0.02). Only 10% (1/10) of the women in the ropivacaine group complained of nausea compared with 44% (4/9) in the control group. Furthermore, 80% (8/10) of women in the ropivacaine group were either very or totally satisfied with their pain relief. Only 56% (5/9) of the women in the control group were very or totally satisfied with their pain relief. Ropivacaine administered by a simple intraperitoneal technique following laparoscopic sterilisation significantly reduces postoperative pain and parenteral analgesic requirements. It would be reasonable to consider this method as standard practice following laparoscopic tubal ligation.1248 - Publication
Clinical Trial Prolonged pre-procedure fasting time is unnecessary when using titrated intravenous ketamine for paediatric procedural sedation.(2004-04)Treston, GregPaediatric procedural sedation (PPS) is a common procedure in most general EDs. Many departmental guidelines suggest mandatory fasting times for children undergoing PPS, in an attempt to decrease the incidence of postoperative vomiting and (theoretically) aspiration pneumonitis, despite there being little or no evidence in the literature to support these mandatory fasting times. To prospectively address the relationship between preprocedure fasting time and intraprocedure or postprocedure vomiting in children aged 1-12 years undergoing procedural sedation with intravenous ketamine in the ED. From January 1999 to May 2000 all children presenting to the Royal Darwin Hospital Emergency Department with a condition requiring ketamine PPS were enrolled for data collection after parental consent was obtained. Titrated intravenous ketamine was administered via protocol. Prospective ED procedural sedation data collection forms of 272 consecutive cases of titrated intravenous ketamine sedation were reviewed. Fasting time was accurately recorded on 257 (95%) data collection forms. There was no intraprocedure vomiting. Overall rate of postprocedure vomiting was 13.9%. No statistically significant association between decreased fasting time and increased incidence of vomiting was found. In fact, there was a trend towards increased incidence of vomiting with increased fasting time (P = 0.08). The rate of vomiting of those children fasted 3 h or greater preprocedure (20/127 or 15.8%) was over twice the rate of those fasted less than 1 hour (2/30 or 6.6%). Incidence of vomiting was significantly associated with increasing age (P = 0.0007). No clinically evident aspiration pneumonitis occurred. Prolonged preprocedure fasting time did not reduce the incidence of postprocedure vomiting in this case series; to the contrary there was a increased incidence of vomiting with longer fasting times (P = 0.08). There was an increase in postprocedure vomiting with increasing age of the patients.1085 - Publication
Clinical Trial Prospective observational study of levosimendan and weaning of difficult-to-wean ventilator dependent intensive care patients.(2008-09) ;Sterba, Martin ;Banerjee, AshokeMudaliar, YuganTo evaluate the role of levosimendan in improving cardiac performance and the success rate of weaning from mechanical ventilation in ventilatordependent, difficult-to-wean patients with impaired cardiac function in the intensive care unit. Prospective, observational study in the ICU of Westmead Hospital, a university-affiliated tertiary referral hospital in Sydney, NSW, between January 2003 and October 2004. 47 ICU patients who were ventilator-dependent for > or =10 days and had failed a weaning or extubation attempt due to respiratory insufficiency were identified as difficult to wean from mechanical ventilation. All were assessed by transthoracic or transoesophageal echocardiography. Twelve who had impaired left ventricular performance (demonstrated by left ventricular ejection fraction [LVEF] <40%) and were already established on diuretic and vasodilator treatment were given a 24-hour infusion of levosimendan. LVEF was measured again within 24 hours after infusion, and weaning from mechanical ventilation and extubation were re-attempted, when clinically deemed feasible. Levosimendan administration was associated with significantly improved LVEF (28.3% before v 34.6% after, P=0.04) and PaO2/FIO2 ratio (179mmHg v 197mmHg, P=0.002) and reduced FIO2 (0.45 v 0.39, P=0.01). These changes were associated with significant improvement in the success rate in weaning from mechanical ventilation (P=0.02), with seven of the 12 patients successfully weaned after levosimendan therapy, and six surviving to hospital discharge. There was no significant difference in any other important parameter between pre- and post-levosimendan weaning attempts. Levosimendan may provide significant benefit to ventilator-dependent patients with impaired left ventricular function. Randomised controlled trials appear justified.1078