Oral Dextrose gel use in asymptomatic hypoglycemic newborns decreases NICU admissions and parenteral dextrose therapy: A retrospective study.

BACKGROUND: Neonatal hypoglycemia is one of the most common causes of admission to neonatal intensive care unit requiring intravenous dextrose therapy. Administration of IV dextrose and transfer to the NICU may interfere with parent-infant bonding, breastfeeding, and has financial implications. OBJECTIVE: Retrospective study to evaluate the effect of dextrose gel supplementation for asymptomatic hypoglycemia in reducing NICU admissions and intravenous dextrose therapy. METHOD: A retrospective study conducted for eight months each before and after introduction of dextrose gel in the management of asymptomatic neonatal hypoglycemia. Asymptomatic hypoglycemic infants were given only feeds in pre dextrose gel period and dextrose gel along with feeds in the dextrose gel period. Rates of admission to NICU and the need of IV dextrose therapy were evaluated. RESULTS: High risk characteristics (Prematurity, Large for Gestational Age, small for Gestational Age, Infants of diabetic mother etc.) were equally distributed among both the cohorts. Primary outcome results showed significant reduction in NICU admissions from 396/1801(22%) to 329/1783 (18.5%) (odds ratio, 95% CI 1.24(1.05-1.46, p 0.008). There was significant reduction in IV dextrose therapy requirement from 277/1405 (15.4%) to 182/1454 (10.2%) (odds ratio, 95% CI 1.59(1.31- 1.95, p < 0.001).Babies discharged on predominant breast feeding showed significant improvement from 237/396(59.8%) in the pre dextrose gel period to 240/329 (72.9%) (odds ratio, 95% CI 0.82(0.73-0.90, p < 0.001) in dextrose gel period. CONCLUSIONS: Dextrose gel supplementation with feeds reduced NICU admissions, the need for parenteral dextrose therapy, avoided maternal separation and promoted breastfeeding.

Inhaled Interferon and Diffusion Capacity in Idiopathic Pulmonary Fibrosis (IPF).

BACKGROUND: Using data from a previously reported phase 2 safety trial, testing inhaled interferon gamma (IFN-γ) for IPF, we analyzed effects on full pulmonary function tests (PFTs) for efficacy before and after therapy and designed a randomized controlled trial of inhaled IFN-γ to treat IPF. METHODS: Ten patients with IPF had received inhaled IFN-γ (Actimmune, InterMune) for 80 weeks. Full PFTs were available 20-50 weeks before Rx and monthly during Rx. Eighty-nine observations were used in the analysis. Linear mixed models for modeling longitudinal data were used to test if the PFT change over time was significantly different before and after IFN-γ. Autoregressive dependence structure with order one was consistently selected as the best one to model the intra-patient correlation over time. Normality assumption was confirmed. Significance level was set at 0.05. Using published literature and our data we performed a sample size calculation based on simulated data. RESULTS: The change over time in DLCO was significantly different before and after IFN-γ treatment. DLCO decreased over time before treatment but increased after treatment (p-value=0.03). Changes in TLC, FRC, RV and FVC were not statistically significant. With a sample size of 60, a placebo controlled, randomized trial has about 90% power to detect a significant difference in the change rate of DLCO in the groups of patients treated with IFN-γ vs placebo. CONCLUSIONS: DLCO was significantly improved following inhaled (IFN-γ) as treatment for IPF. Our data suggest that previous studies utilizing parenteral IFN-γ may have failed because of the mode of delivery. Future randomized, controlled, phase 3 trials, comparing the difference in PFT behavior (specifically DLCO) longitudinally may be more sensitive to drug effect and serve as a valuable clinical endpoint.

A phase II study of mitomycin C, cisplatin and protracted infusional 5-fluorouracil in advanced pancreatic carcinoma: efficacy and low toxicity.

BACKGROUND: The effective treatment of unresectable pancreatic carcinoma represents a formidable challenge. There is a need to develop systemic therapies which combine efficacy with acceptable toxicity. The current 'gold standard' gemcitabine gives an objective response rate of the order of 20% and median survival up to 6 months. Here we have evaluated the efficacy and toxicity of mitomycin C, cisplatin and protracted infusional 5-fluorouracil (MCF). PATIENTS AND METHODS: Forty-five patients with locally advanced (13 patients) or metastatic (32 patients) pancreatic carcinoma were treated with mitomycin C 7 mg/m(2) 6 weekly, cisplatin 60 mg/m(2) 3 weekly and protracted venous infusion 5-FU 300 mg/m(2)/day. Patients were evaluated for response after three cycles and received six cycles in total in the absence of progressive disease or poor tolerance. Median age was 62 (45-75) years; 41 patients were World Health Organization performance status 0-1. RESULTS: Treatment was well tolerated with 36 (84%) patients completing three or more cycles. Grade 3 or 4 toxicities were uncommon: anaemia in three patients (7%), mucositis in two (5%), nausea and vomiting in three (7%) and diarrhoea in one (1%). An objective response was seen in 21 (46%) patients. There was one complete response. The median survival overall was 7.1 months and 10.5 months in responders. The median duration of response was 4.3 months. One-year survival was 29%, 2-year survival was 18%. CONCLUSIONS: MCF combines efficacy with low toxicity in the treatment of advanced pancreatic carcinoma. The efficacy is at least comparable and may be superior to single-agent gemcitabine and MCF may therefore provide a cost-effective alternative.