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עמוד בית
Sat, 01.04.23

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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.

September 2020
Ella Schwarzmann Aley-Raz MD, Gil Talmon MD, Marina Peniakov MD, Jamal Hasanein MD, Clari Felszer-Fisch MD and Scott A. Weiner MD

Background: Neonatal hypothermia (< 36°C) has been associated with both neonatal morbidity and mortality.

Objectives: To develop a multifactorial approach to reduce the incidence of neonatal hypothermia at admission to the neonatal intensive care unit.

Methods: The approach involved a detailed quality improvement (QI) plan, which included the use of occlusive wrapping and exothermic mattresses as well as higher delivery and operating room environmental temperatures. The improvement plan was implemented over a 10-month period. Retrospective comparison to the same 10-month period during the previous year assessed the effectiveness of the approach in reducing the incidence of admission hypothermia.

Results: The QI project included 189 patients. These patients were compared to 180 patients during the control period. The characteristics of the patient groups were similar and included preterm infants, who were subsequently analyzed as a subgroup. We found a significant reduction in the incidence of hypothermia, which was most profound for the subgroup of premature infants born at < 32 weeks gestation. Neonatal hyperthermia was identified as an unintended consequence of the project, and subsequently improved after initiating simple preventive measures.

Conclusions: Occlusive wrapping, exothermic mattresses, and higher delivery and operating room environmental temperature may be successful in reducing admission neonatal hypothermia

Arieh Riskin MD PhD, Omer Itzchaki BSc, David Bader MD MHA, Adir Iofe MD, Arina Toropine MD and Shlomit Riskin-Mashiah MD MPH

Background: The incidence of gestational diabetes mellitus (GDM) is increasing in parallel to the worldwide obesity and type 2 diabetes pandemic. Both GDM and pre-gestational diabetes mellitus (PGDM) are associated with short- and long-term consequences in the offspring. There are few recent studies addressing outcomes of newborns born to women diagnosed with GDM and PGDM in Israel.

Objectives: To assess perinatal complications in offspring of women with GDM and PGDM.

Methods: The authors conducted a single-center retrospective case-control study of outcomes of all newborns whose mothers had been diagnosed with diabetes in pregnancy compared to randomly assigned controls born on the same date, whose mothers had no diabetes.

Results: In the study period 2015–2017, 526 mothers diagnosed with GDM or PGDM and their newborn infants were identified. The authors randomly assigned 526 control infants. The rate of women with diabetes in pregnancy was 5.0%. Mothers with GDM and PGDM had higher rates of pre-eclampsia, multiple pregnancies, and preterm deliveries. Mothers with PGDM had significantly higher rates of intrauterine fetal demise (4.3%), congenital anomalies (12.8%), and small-for-gestational-age neonates (10.6%) compared to controls (0%, 3.2%, and 4.2%, respectively, P < 0.001). The risks for preterm or cesarean delivery, large-for-gestational-age neonate, respiratory morbidity, hypoglycemia, and polycythemia were increased in offspring of mothers with diabetes, especially PGDM.

Conclusions: Despite all the advancements in prenatal care, diabetes in pregnancy, both PGDM and GDM, is still associated with significant morbidities and complications in offspring. Better preconception and inter-pregnancy care might reduce these risks

November 2019
Ram Mazkereth MD, Ayala Maayan-Metzger MD, Leah Leibovitch MD, Irit Schushan-Eisen MD, Iris Morag MD and Tzipora Straus MD M.Sc

Background: The need for postnatal monitoring of infants exposed to intrauterine beta blockers (BBs) has not been clearly defined.

Objectives: To evaluate infants exposed to intrauterine BBs in order to estimate the need for postnatal monitoring.

Methods: This retrospective case-control study comprised 153 term infants born to mothers who had been treated with BBs during pregnancy. Treatment indications included hypertension 76 mothers (49.7%), cardiac arrhythmias 48 (31.4%), rheumatic heart disease 14 (9.1%), cardiomyopathy 11 (7.2%) and migraine 4 (2.6%). The controls were infants of mothers with hypertension not exposed to BBs who were born at the same gestational age and born closest (before or after) to the matched infant in the study group.

Results: Compared to the control group, the infants in the study group had a higher prevalence of early asymptomatic hypoglycemia (study 30.7% vs. control 18.3%, P = 0.016), short symptomatic bradycardia events, other cardiac manifestations (P = 0.016), and longer hospitalization (P < 0.001). No life-threatening medical conditions were documented. The birth weight was significantly lower for the high-dose subgroup compared to the low-dose subgroup (P = 0.03), and the high-dose subgroup had a higher incidence of small-for-gestational-age (P = 0.02).

Conclusions: No alarming or life-threatening medical conditions were observed among term infants born to BB treated mothers. These infants can be safely observed for 48 hours after birth close to their mothers in the maternity ward. Glucose follow-up is needed, especially in the first hours of life.


March 2018
Leah Leibovitch MD, Iris Zohar MD, Ayala Maayan-Mazger MD, Ram Mazkereth MD, Tzipora Strauss MD and Ron Bilik MD

Background: The estimated incidence of esophageal atresia (EA) with or without tracheo-esophageal fistula (TEF) is 1:3500 live births. During childhood these patients have various co-morbidities, but the overall quality of life among adults is similar to that of the general population.

Objectives: To evaluate short- and long-term co-morbidities and quality of life among infants born with EA ± TEF at a large single medical center.

Methods: Medical records of 65 children born over a 21 year period were reviewed for short- and long-term medical data. Telephone interviews were conducted with 46 of their parents regarding medical problems and quality of life after home discharge.

Results: The main long-term co-morbidities during the first 2 years of life, 4–6 years of age, and during adolescence (12–16 years) included gastro-esophageal reflux disease (GERD) in 56.5%, 35.8%, and 18.7%, respectively; stridor in 84.8%, 45.2%, and 12.5%, respectively; hyper-reactive airway disease (HRAD) in 43.5%, 35.5%, and 36.5%, respectively; recurrent pneumonia in 43.5%, 32.3%, and 18.8%, respectively; and overall recurrent hospitalizations in 87%, 41.9%, and 25%, respectively. The quality of life was reportedly affected among 100%, 75%, and 33.3% respectively.

Conclusions: Long-term follow-up of patients with EA ± TEF indicates a high burden of co-morbidities during the first 6 years of life, with a gradual decrease in symptoms thereafter. Nevertheless, HRAD continued to impact the daily life of about one-third of the older adolescents, and GERD one-fifth. A long-term multidisciplinary follow-up should be conducted to prevent late onset complications that may affect the quality of life.

December 2016
Amit Dagan MD and Ovadia Dagan MD

Background: Early surgical correction of congenital heart malformations in neonates and small infants may be complicated by acute kidney injury (AKI), which is associated with higher morbidity and mortality rates, especially in patients who require dialysis. Glomerular filtration rate (GFR) is considered the best measurement of renal function which, in neonates and infants, is highly dependent on heart function. 

Objective: To determine whether measurements of creatinine clearance after open heart surgery in neonates and young infants can serve as an early indicator of surgical success or AKI.

Method: We conducted a prospective observational study in 19 neonates and small infants (body weight < 5 kg) scheduled for open heart surgery with cardiopulmonary bypass. Urine collection measurement of creatinine clearance and albumin excretion was performed before and during surgery and four times during 48 hours after surgery.

Results: Mean creatinine clearance was lowest during surgery (25.2 ± 4. ml/min/1.73 m2) and increased significantly in the first 16 hours post-surgery (45.7 ± 6.3 ml/min/1.73 m2). A similar pattern was noted for urine albumin which was highest during surgery (203 ± 31 µg/min) and lowest (93 ± 20 µg/min) 48 hours post-surgery. AKI occurred in four patients, and two patients even required dialysis. All six showed a decline in creatinine clearance and an increase in urine albumin between 8 and 16 hours post-surgery. 

Conclusions: In neonates and small infants undergoing open heart surgery, a significant improvement in creatinine clearance in the first 16 hours postoperatively is indicative of a good surgical outcome. This finding has important implications for the early evaluation and treatment of patients in the intensive care unit on the first day post-surgery.


June 2015
Arieh Riskin MD MHA, Corina Hartman MD and Raanan Shamir MD


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

July 2014
Natalya Bilenko MD PhD MPH, Drora Fraser PhD, Hillel Vardy BA and Ilana Belmaker MD MPH
Background: A high prevalence of iron deficiency anemia persists in Bedouin Arab and Jewish pediatric populations in southern Israel.

Objectives: To compare the effect of daily use of multiple micronutrient supplementation (MMS), "Sprinkles," a powdered formulation of iron, vitamins A and C, folic acid and zinc, with liquid iron and vitamins A and D on iron deficiency at 12 months of age.

Methods: The 621 eligible Bedouin and Jewish infants in the study were assigned to the MMS and control arms and received their supplementations from age 6 to 12 months. We examined the change in hemoglobin, hematocrit, mean cell volume, red blood cell distribution, serum ferritin and transferrin saturation. In addition, we used the high Iron Deficiency Index (IDI) if two or more of the above six parameters showed abnormal levels. 

Results: Rates of anemia decreased significantly over the 6 month period, from 58.8% to 40.6% among Bedouin infants (P = 0.037) and from 40.6 to 15.8% among Jewish infants (P = 0.017). In Bedouin infants the prevalence of high IDI decreased significantly from 79.2% to 67.4% (P = 0.010) in the MMS group, but there was no change in the controls. Among Jewish infants, the high IDI prevalence decreased from 67% to 55.6% with no statistically significant difference in the two study arms. In the multivariate analysis in Bedouin infants MMS use was associated with a reduced risk of 67% in high IDI at age 12 months as compared to controls (P = 0.001). Fewer side effects in the intervention groups in both ethnic populations were reported.

Conclusions: MMS fortification of home food can be recommended as an effective and safe method for preventing iron deficiency anemia at 12 months of age. 
March 2014
Orly Goitein, Yishay Salem, Jeffrey Jacobson, David Goitein, David Mishali, Ashraf Hamdan, Rafael Kuperstein, Elio Di Segni and Eli Konen
 Background: Patients with complex congenital heart disease (CHD) have a high incidence of extracardiac vascular and non-vascular malformations. Those additional abnormalities may have an impact on the precise planning of surgical or non-surgical treatment.

Objectives: To assess the role of electrocardiography-gated CT-angiography (ECG-CTA) in the routine evaluation of CHD in neonates and infants particularly for the assessment of extracardiac findings.

Methods: The study cohort comprised 40 consecutive patients who underwent trans-thoracic echocardiography (TTE) and ECG-CTA. TTE and ECG-gated CTA findings regarding extracardiac vascular structures, coronary arteries and airways were compared with surgical or cardiac catheterization findings. Scans were evaluated for image quality using a subjective visual scale (from 1 to 4). Effective radiation dose was calculated for each scan.

Results: Median age was 28 ± 88 days and mean weight 3.7 ± 1.5 kg. Diagnostic quality was good or excellent (visual image score 3–4) in 39 of 40 scans (97.5%). ECG-CTA provided important additional information regarding extracardiac vascular structures and airway anatomy, complementing TTE in 75.6% of scans. Overall sensitivity of ECG-gated CTA for detecting extracardiac findings as compared with operative and cardiac catheterization findings was 97.6%. The calculated mean effective radiation dose was 1.4 ± 0.07 mSv (range 1.014–2.3 mSv).

Conclusions: ECG-CTA is an accurate modality for demonstrating extracardiac structures in complex CHD. It provides important complementary information to TTE regarding extracardiac vascular structures and coronary artery anatomy. This modality may obviate the need for invasive cardiac catheterization, thus exposing the patient to a much lower radiation dose. 

May 2013
E. Nahum, U. Pollak, O. Dagan, G. Amir, G. Frenkel and E. Birk
 Background: B-type natriuretic peptide (BNP) has been shown to have prognostic value for morbidity and mortality after cardiac surgery. Less is known about its prognostic value in infants.

Objectives: To investigate the predictive value of BNP levels regarding the severity of the postoperative course in infants undergoing surgical repair of congenital heart disease.

Methods: We conducted a prospective comparative study. Plasma BNP levels in infants aged 1–12 months with congenital heart disease undergoing complete repair were measured preoperatively and 8, 24 and 48 hours postoperatively. Demographic and clinical data included postoperative inotropic support and lactate level, duration of mechanical ventilation, intensive care unit (ICU) and hospitalization stay.

Results: Cardiac surgery was performed in 19 infants aged 1-12 months. Preoperative BNP level above 170 pg/ml had a positive predictive value of 100% for inotropic score ≥ 7.5 at 24 hours (specificity 100%, sensitivity 57%) and 48 hours (specificity 100%, sensitivity 100%), and was associated with longer ICU stay (P = 0.05) and a trend for longer mechanical ventilation (P = 0.12). Similar findings were found for 8 hours postoperative BNP above 1720 pg/ml. BNP level did not correlate with measured fractional shortening.

Conclusions: In infants undergoing heart surgery, preoperative and 8 hour BNP levels were predictive of inotropic support and longer ICU stay. These findings may have implications for preplanning ICU loads in clinical practice. Further studies with larger samples are needed.

January 2013
V. Nir, E. Nadir, M. Mekonen and M. Feldman
 Background: Ethnic differences in the incidence of spitting up have not been reported. The nursing team at our well-baby nursery observed that newborn infants of Ethiopian origin appeared to spit up more than the others.

Objective: To determine whether there are such ethnic differences and what, if anything, is their clinical relevance.

Methods: Of the 3663 enrolled infants born at the Hillel Yaffe Medical Center during the 12 month study period, 55 were of Ethiopian origin and their medical records were retrospectively surveyed. The retrieved data were compared with those of 167 randomly selected non-Ethiopian newborns (controls). Exclusion criteria were preterm delivery, admission to the neonatal intensive care unit, and congenital birth defects.

Results: Newborn infants of Ethiopian origin spit up 57% more than control infants. The difference in the number of spit ups was more obvious when only the infants who spit up were compared (2.3 ± 1.7 Ethiopian newborns vs. 1.5 ± 0.9 controls, P = 0.002), although the percentage of infants who spit up was the same in the two groups. There was no difference in weight gain, days of hospitalization, bilirubin levels or nutrition type between the groups.

Conclusions: Infants of Ethiopian origin spit up more than the control newborn infants of non-Ethiopian origin, while other clinical parameters were similar. In the absence of other pathological signs, spitting up is a non-relevant clinical condition.



A.J. Jacobs
 Infant circumcision has recently attracted controversy, with professional groups recommending it and various individuals trying to criminalize it. Circumcision is beneficial in the prevention of certain diseases, causing minimal tangible harm to those circumcised. This article argues that government should affirmatively adopt policies tolerating minority practices. Such activities should be banned only if they cause substantial damage to society or its members, or if they engender risks or injuries to which no reasonable person would consent. The benefits and risks of circumcision are outlined. Circumcision of male infants does not trigger cause for government to abolish it, and should be permitted if parents desire it. This article also summarizes common arguments against circumcision and attempts to refute them. These arguments are based on a desire for gender equality as well as a belief that minors should not undergo elective bodily alteration. If there are no unusual risks, parents can ethically authorize, and physicians ethically perform, elective infant circumcision for prophylaxis of disease, ritual purposes, or aesthetic reasons. Furthermore, the state should permit this.


December 2012
M. Shamir, R. Dickstein and E. Tirosh

Background: The effectiveness of intensive versus standard physical therapy for motor progress in children with cerebral palsy is controversial. Sitting acquisition is considered an important developmental milestone.  

Objectives: To assess the acquisition of sitting and gross motor progress in infants with cerebral palsy treated with intermittent intensive physical therapy as compared to a matched group treated with a standard physical therapy regimen.

Methods: We conducted a randomized controlled crossover study in 10 infants aged 12–22 months with cerebral palsy; 5 were assigned to the intensive intermittent therapy group and 5 to the control group. After 4 weeks of baseline intervention, the intervention program was administered to the experimental group for 8 weeks and the regularly scheduled weekly program to the comparison group, targeting sitting as the treatment goal. Thereafter the comparison group crossed over. The Gross Motor Function Measure 66 and 88 (GMFM 66 and 88) were used at 4 week intervals.

Results: The intermittent intensive regimen yielded a mean improvement of 7.8% and 1.2% in the two groups respectively. However, these results were attributed to infants with a low functional level only (P < 0.01).

Conclusions: Goal-directed intensive intermittent regimen could possibly be beneficial in infants with a low functional level.

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