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עמוד בית
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November 2021
Naim Shehadeh MD and Raanan Shamir MD
September 2021
Naim Shehadeh MD, Aryeh Simmonds MD, Samuel Zangen MD, Arieh Riskin MD MHA, and Raanan Shamir MD

Background: Infants born very prematurely have functionally and structurally immature gastrointestinal tracts.

Objectives: To assess the safety and tolerability of administration of enteral recombinant human (rh) insulin on formula fed preterm infants and to assess whether enteral administration of rh-insulin enhances gastrointestinal tract maturation by reducing the time to reach full enteral feeding.

Methods: A phase 2, multicenter, double-blind, placebo-controlled, randomized study was conducted. Premature infants (26–33 weeks gestation) were randomized 1:1 to receive insulin 400 μU/ml mixed with enteral feeding or placebo added to their formula. The primary efficacy outcome measure was the number of days required to achieve full enteral feeding. Safety outcomes included adverse events and blood glucose levels.

Results: The study consisted of 33 infants randomized for the safety population and 31 for efficacy analysis. The mean time to full enteral feeding was 6.37 days (95% confidence interval [95%CI] 4.59–8.15) in the enteral rh-insulin treatment group (n=16) and 8.00 days (95%CI 6.20–9.80) in the placebo group (n=15), which represents a statistically significant reduction of 1.63 days (95%CI 0.29–2.97; P = 0.023). There was no difference in blood glucose levels between the groups and none of the participants experienced hypoglycemia. Adverse events occurred in 9/17 (53%) infants in the enteral rh-insulin group and 12/16 (75%) in the placebo group.

Conclusions: Our trial demonstrated that administration of enteral rh-insulin as supplement to enteral nutrition significantly reduced time to achieve full enteral feeding in preterm infants with a gestational age of 26–33 weeks.

March 2020
Tal David Berger MD, Shelly Soffer MD, Tal Vurzel-Harel MD, Ari Silbermintz MD, Hava Fleishaker, Raanan Shamir MD and Noam Zevit MD

Background: The number of investigative esophagogastroduodenoscopies (EGD) in children has increased over several decades, despite their unclear diagnostic yields.

Objectives: To evaluate the indications for performing EGD, their diagnostic yields, and consequences on pediatric patient management.

Methods: A retrospective chart review was performed of consecutive pediatric patients aged 0–18 years, who underwent EGD between January and August 2014.

Results: During the study period, 547 EGD were performed on 478 children. The most frequent indications were suspected celiac disease, chronic non-specific abdominal pain, persistent Helicobacter pylori infection, and gastrointestinal hemorrhage. The yield of the diagnostic EGD was 59.2%, and the most common new diagnoses were celiac disease (28%), Helicobacter pylori-positive gastritis (16.5%), and Crohn’s disease (5.4%). Of the patients with documented follow-up, 74.1% reported improved symptoms. Procedures performed for chronic unexplained abdominal pain had significantly lower yields (26.2%) and only 39.3% improved at follow-up.

Conclusions: Our findings suggest a general high diagnostic yield for EGD in pediatric patients, stemming mainly from patients in whom a specific condition was suspected a priori. However, the role of the procedure in the diagnosis and management of non-specific gastrointestinal complaints was minor suggesting that EGD may be superfluous for some of these patients.

June 2019
Hagar Interator MSx RD, Avivit Brener MD, Moshe Hoshen PhD, Inbar Safra MD, Ran Balicer MD PhD MPH, Moshe Leshno MD PhD, Raanan Shamir MD and Yael Lebenthal MD

Background: In Israel, coronary heart disease mortality rates are significantly higher among the Arab population than the Jewish population. Dyslipidemia prevention should begin in childhood.

Objectives: To identify sociodemographic disparities in the preventive health measurement of lipid profile testing and lipoprotein levels among Israeli children and adolescents.

Methods: A cross-sectional analysis of 1.2 million children and adolescents insured by Clalit Health Services between 2007 and 2011 was conducted using sociodemographic data and serum lipid concentrations.

Results: Overall, 10.1% individuals had undergone lipid testing. Those with male sex (odds ratio [OR] = 0.813, 95% confidence interval [95%CI] 0.809–0.816), Arab ethnicity (OR = 0.952, 95%CI 0.941–0.963), and low socioeconomic status (SES) (OR = 0.740, 95%CI 0.728–0.752) were less likely to be tested. By 2010, differences among economic sectors narrowed and Arab children were more likely to be tested (OR = 1.039, 95%CI 1.035–1.044). Girls had higher total cholesterol, triglyceride, low-density lipoprotein-cholesterol, and non-high-density lipoprotein-cholesterol levels compared to boys (P < 0.001). Jewish children had higher cholesterol and low-density and high-density lipoprotein-cholesterol, as well as lower triglyceride levels than Arabs (P < 0.001). Children with low SES had lower cholesterol, low-density and high-density lipoprotein-cholesterol, and non-high-density lipoprotein-cholesterol levels (P < 0.001).

Conclusions: We found that boys, Arab children, and those with low SES were less likely to be tested. Over time there was a gradual reduction in these disparities. Publicly sponsored healthcare services can diminish disparities in the provision of preventive health among diverse socioeconomic groups that comprise the national population.

February 2019
Assaf Hoofien MD, Yael Mozer MD, Anat Guz-Mark MD, Vered Hoffer MD, Daniel Landau MD and Raanan Shamir MD
June 2015
Arieh Riskin MD MHA, Corina Hartman MD and Raanan Shamir MD

Abstract

Parenteral nutrition (PN) must be initiated as soon as possible after delivery in very low birth weight (VLBW) preterm infants in order to prevent postnatal growth failure and improve neurodevelopmental outcome. When administered early, high levels of parenteral amino acids (AA) are well tolerated and prevent negative nitrogen balance. Although proteins are the driving force for growth, protein synthesis is energy demanding. Intravenous lipid emulsions (ILE) constitute a good energy source because of their high energy density and provide essential fatty acids (FA) along with their long-chain polyunsaturated fatty acid (LC-PUFA) derivatives necessary for central nervous system and retinal development. Early supply of ILE is not associated with increased morbidity. No significant differences were found between ILE based on soybean oil only and mixed ILE containing soybean oil in combination with other fat sources, except for a reduction in the incidence of sepsis with non-pure soybean ILE, and possibly less PN-associated liver disease with mixed ILE containing some fish oil. In preterm infants glucose homeostasis is still immature in the first days of life and abnormalities of glucose homeostasis are common. VLBW infants may not tolerate high levels of glucose infusion without hyperglycemia. Administering lower levels of glucose infusion as part of full early PN seems more successful than insulin at this stage. Postpartum there is a transition period when the water and electrolyte balance may be severely disturbed and should be closely monitored. Avoiding fluid overload is critical for preventing respiratory and other morbidities

March 2015
Firas Rinawi MD, Theodore C. Iancu MD, Corina Hartman MD, Hofit Cohen MD, Havatzelet Yarden-Bilavsky MD, Michal Rozenfeld Bar Lev MD and Raanan Shamir MD
February 2011
Y. Mozer-Glassberg, I. Hojsak, N. Zevit, R. Shapiro and R. Shamir
July 2008
C. Hartman, D. Berkowitz, B. Weiss, R. Shaoul, A. Levine, O. Eshach Adiv, R. Shapira, A. Fradkin, M. Wilschanski, A. Tamir and R. Shamir

Background: A polymeric diet rich in transforming growth factor-beta 2 used as a single nutrient has been shown to induce remission in 79% of children with Crohn's disease.

Objectives: To summarize the experience of several pediatric gastroenterology units in Israel using a TGFβ2[1]-enriched polymeric diet (Modulen IBD) supplementation in children and adolescents with Crohn's disease.

Methods: In a retrospective study we reviewed the charts of 28 children with Crohn's disease (10 girls, 18 boys) who received, in addition to conventional treatment, Modulen IBD™ as a supplement to their regular nutrition. These children were compared with 18 children supplemented with standard polymeric formula (Ensure Plus®) and 18 children without formula supplementation. We recorded clinical manifestations, growth, and the Pediatric Crohn's Disease Activity Index before and after initiation of the polymeric diet.

Results: The Modulen-treated children showed a significant decrease in PCDAI[2] from 34.3 to 15.7 (P < 0.0001). A significant decrease in PCDAI was recorded also in the Ensure Plus group, from 35 to 22 (P = 0.02) but not in the non-supplemented group. Significant improvements in body mass index (P = 0.01) and erythrocyte sedimentation rate (P = 0.03) were recorded at follow-up (median 3.4 months) only in the Modulen IBD group.

Conclusions: In this cohort of children with Crohn's disease, supplementation of the diet with Modulen IBD as well as supplementation with Ensure Plus was associated with a decrease in PCDAI. The children supplemented with Modulen IBD also showed improvement in BMI[3], suggesting an additional advantage of nutritional therapy in children with this disease.






[1] TGF-β2 = transforming growth factor-β2

[2] PCDAI = Pediatric Crohn's Disease Activity Index

[3] BMI = body mass index


September 2006
A. Riskin, Y. Shiff and R. Shamir

Premature very low birth weight (< 1500 g) infants are one of the largest groups receiving parenteral nutrition. PN[1] should be optimized to answer their large nutritional requirements and suit their metabolic status, but should also be validated pharmaceutically. PN can be provided as a standard, usually commercial, formulation, representing the average needs of a large group of patients. Alternatively, an individualized PN compound adapted to the patient's needs can be prescribed and prepared, usually on a daily basis. The main advantage of individually prescribed PN is that it is tailored to suit a specific patient, thereby assuring the best possible nutrition and biochemical control. Batch-produced standardized PN bags can be readily available as ward stocks in neonatal intensive care units, enabling initiation of early PN immediately after the delivery of a premature infant. Moreover, standard PN solutions incorporate expert nutritional knowledge and support. A combination of standardized PN bags, prepared under strict standardization criteria, for most neonates, with a small number of specifically tailored individualized PN formulations for those in need for them, could reduce pharmacy workload and costs, and increase safety, while maintaining the desired clinical flexibility. For those in need of the individualized PN formulations, a computerized ordering system can save time, decrease prescription and compounding errors, and improve quality of nutritional care.






[1] PN = parenteral nutrition


August 2006
July 2003
C. Hartman, Z. Hochberg and R. Shamir
August 2002
Raanan Shamir, MD, Rami Eliakim, MD, Nitza Lahat, PhD, Esther Sobel, MSc and Aaron Lerner, MD, MHA

Background: Celiac disease is common in both children and adults. Small intestinal biopsy is mandatory for establishing a diagnosis. Anti-endomysial antibodies, detected by immunofluorescence, have a sensitivity and specificity close to 100% in the diagnosis of CD[1]. Recently, tissue transglutaminase has been identified as the target autoantigen of antibodies against endomysium, and TTG[2] antibodies are comparable to EMA-IMF[3] in the diagnosis of CD.

Objective: To evaluate a new enzyme-linked immunosorbent assay kit for EMA, compared to EMA-IMF and TTG antibodies in the diagnosis of CD.

Methods: Our study population included all subjects with positive EMA-IMF who underwent intestinal biopsy (n=21). From the same sera, TTG antibodies and EMA-ELISA[4] were determined, and all antibody results were compared to the biopsy findings.

Results: EMA-IMF was able to predict biopsy findings of CD in 19 of 21 cases (90.5%). When patients with biopsy findings compatible with CD and positive EMA-IMF (n=19) were tested for EMA-ELISA and TTG antibodies, 18 of the 19 were positive for both EMA-ELISA and TTG antibodies. A significant correlation was found between EMA-ELISA and TTG antibody titers (r = 0.74, P < 0.001).

Conclusions: Our study demonstrates that EMA-ELISA is comparable to TTG antibodies in the diagnosis of CD, and supports the use of EMA-ELISA as a serologic marker for this disease.


_______________________

[1]
CD = celiac disease

[2] TTG = tissue transglutaminase

[3] EMA-IMF = anti-endomysial antibodies measured by immunofluorescence

[4] ELISA = enzyme-linked immunosorbent assay

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