Hannover, Germany
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Gopel W.,University of Lübeck | Kribs A.,University of Cologne | Ziegler A.,University of Lübeck | Laux R.,Asklepios Klinik Barmbek | And 13 more authors.
The Lancet | Year: 2011

Surfactant is usually given to mechanically ventilated preterm infants via an endotracheal tube to treat respiratory distress syndrome. We tested a new method of surfactant application to spontaneously breathing preterm infants to avoid mechanical ventilation. In a parallel-group, randomised controlled trial, 220 preterm infants with a gestational age between 26 and 28 weeks and a birthweight less than 1·5 kg were enrolled in 12 German neonatal intensive care units. Infants were independently randomised in a 1:1 ratio with variable block sizes, to standard treatment or intervention, and randomisation was stratified according to centre and multiple birth status. Masking was not possible. Infants were stabilised with continuous positive airway pressure and received rescue intubation if necessary. In the intervention group, infants received surfactant treatment during spontaneous breathing via a thin catheter inserted into the trachea by laryngoscopy if they needed a fraction of inspired oxygen more than 0·30. The primary endpoint was need for any mechanical ventilation, or being not ventilated but having a partial pressure of carbon dioxide more than 65 mm Hg (8·6 kPa) or a fraction of inspired oxygen more than 0·60, or both, for more than 2 h between 25 h and 72 h of age. Analysis was by intention to treat. This study is registered, number ISRCTN05025922. 108 infants were assigned to the intervention group and 112 infants to the standard treatment group. All infants were analysed. On day 2 or 3 after birth, 30 (28) infants in the intervention group were mechanically ventilated versus 51 (46) in the standard treatment group (number needed to treat 6, 95 CI 3-20, absolute risk reduction 0·18, 95 CI 0·30-0·05, p=0·008). 36 (33) infants in the intervention group were mechanically ventilated during their stay in the hospital compared with 82 (73) in the standard treatment group (number needed to treat: 3, 95 CI 2-4, p<0·0001). The intervention group had significantly fewer median days on mechanical ventilation, (0 days. IQR 0-3 vs 2 days, 0-5) and a lower need for oxygen therapy at 28 days (30 infants [30] vs 49 infants [45], p=0·032) compared with the standard treatment group. We recorded no differences between groups for mortality (seven deaths in the intervention group vs five in the standard treatment group) and serious adverse events (21 vs 28). The application of surfactant via a thin catheter to spontaneously breathing preterm infants receiving continuous positive airway pressure reduces the need for mechanical ventilation. German Ministry of Research and Technology, University of Lübeck, and Chiesi Pharmaceuticals. © 2011 Elsevier Ltd.


Olsen B.S.,Glostrup University Hospital | Lilleore S.K.,Novo Nordisk AS | Korsholm C.N.,Novo Nordisk AS | Kracht T.,Kinderkrankenhaus Auf der Bult
Journal of Diabetes Science and Technology | Year: 2010

Background: Despite advances in insulin pen design and functionality, the selection of pens available for children with diabetes is limited. This study assessed the usability, functionality and attitudes towards NovoPen Echo®, a new durable insulin pen designed for pediatric patients that combines a simple memory function with half-increment dosing, versus NovoPen® Junior and HumaPen® Luxura™ HD in pediatric subjects, their parents, and health care professionals (HCPs). Methods: Pens were evaluated in random order during 1:1 interviews in the three target groups (pediatric subjects, parents, and HCPs) in Germany, France, and Canada. Study participants were asked to prepare each pen, perform injections into foam cushions, and provide feedback via a standardized questionnaire. Results: In total, 205 participants were included in the study. On a scale of 1-6 (1 = most favorable; 6 = least favorable regarding overall appearance, shape, colors, thickness and length), NovoPen Echo received the most favorable rating for design and overall appearance (mean ± standard deviation = 1.71 ± 0.79) compared with NovoPen Junior (2.02 ± 0.93) and HumaPen Luxura HD (2.36 ± 1.01). Furthermore, 89% of pediatric subjects and 94% of parents rated the memory function of NovoPen Echo as very easy/easy to use. When asked to rate the pens overall, 80% of participants preferred NovoPen Echo to the other pens (p < 0.0001). Conclusions: The results demonstrate a high overall level of satisfaction with NovoPen Echo among pediatric subjects, parents, and HCPs. The novel design aspects of NovoPen Echo, namely t1468-he simple memory function, half-increment units and, ease of use and design, may contribute towards promoting treatment adherence, which is essential in the pediatric setting. © Diabetes Technology Society.


Schukfeh N.,Hannover Medical School | Schukfeh N.,University of Duisburg - Essen | Reismann M.,Hannover Medical School | Ludwikowski B.,Kinderkrankenhaus auf der Bult | And 4 more authors.
European Journal of Pediatric Surgery | Year: 2014

Abstract Fast-track concepts in pediatric surgery were established in a university hospital in consecutive studies within several years. They significantly reduced the length of hospitalization compared with German institutions without fast-track protocols. The aim of this study was to assess the implementation process of fast-track in a German nonacademic department of pediatric surgery without previous fast-track experience. All patients undergoing four types of operations (appendectomy, hypospadias repair, pyloromyotomy, and fundoplication) from February 2011 to January 2012 were included in this prospective study. Fast-track included detailed clinical pathways and specific pain treatment protocols using validated pain scales according to age. Mobilization and oral nutrition were started 2 hours postoperatively and documented with established scores. The length of hospital stay was compared with data from other hospitals with conventional treatment using information from the German reimbursement system (German diagnosis-related groups [G-DRG]) and with the hospital stay of patients from the corresponding university hospital undergoing fast-track treatment for the same procedures during the same study period. Two weeks after discharge, a questionnaire was completed by the patients/parents. A total of 143 patients with a mean age of 7.9 ± 5.0 years underwent fast-track treatment. The mean pain intensity during the immediate postoperative period was 1.7 ± 2.1 in patients < 4 years and 2.3 ± 2.1 in patients ≥ 4 years on a 10-point scale. Full mobilization was reached after a mean duration of 2.3 ± 2.0 days while full oral nutrition was completed after a mean duration of 1.8 ± 1.4 days. There were no complications associated with fast-track. The mean hospital stay was 5.8 ± 3.4 days which was not significantly different compared with G-DRG data from other hospitals without fast-track. This was in contrast to the mean hospital stay of patients from the corresponding university hospital (5.6 ± 3.0 days vs. G-DRG 6.9 ± 3.2 days, p < 0.05). After 2 weeks, patients/parents were highly satisfied with fast-track (mean score of 8.6 ± 1.4 on a 1-10-point scale) and 95.2% claimed that they would choose it again. Fast-track concepts can be applied in a nonacademic department of pediatric surgery without previous fast-track experience and with excellent patient/parent satisfaction. However, the G-DRG system interferes with concepts of early discharge of patients. Modifications of the reimbursement modalities within the German health care system seem to be mandatory. © 2014 Georg Thieme Verlag KG.


Guthmann F.,Kinderkrankenhaus Auf der Bult | Guthmann F.,Charité - Medical University of Berlin | Arlettaz Mieth R.P.,University of Zürich | Bucher H.U.,University of Zürich | Buhrer C.,Charité - Medical University of Berlin
Acta Paediatrica, International Journal of Paediatrics | Year: 2016

Aim Prophylactic probiotics to reduce necrotising enterocolitis (NEC) are mostly given for at least 28 days or until discharge. We describe the effects of a shorter duration dosing strategy. Methods Retrospective cohort study of neonates (birthweight 400-1500 g) in three neonatal intensive care units in Switzerland and Germany that embarked on probiotic prophylaxis given for 10 or 14 days, employing a fixed combination (Lactobacillus acidophilus plus Bifidobacterium infantis, each 109 CFU/day) licensed as a drug in Switzerland. Probiotics were initiated upon discontinuation of antibiotics, or on day 1-3 in infants without antibiotics. Repeat probiotic courses were given whenever antibiotics had been instituted and were discontinued. Results Birthweight and gestational age were similar in the two 24-month pre- and postimplementation cohorts. NEC rates fell from 33 of 633 (5.2%) to 8 of 591 infants alive at three days (1.4%; risk ratio (RR) 0.26, 95% confidence interval (CI) 0.12-0.55). The drop in NEC was significant both for infants of 400-999 g (6.4% to 2.5%) and 1000-1500 g birthweight (4.4% to 0.6%). Mortality was 5.1% (32/633) without, as opposed to 3.5% (21/591) with probiotics, respectively (RR 0.69, 95% CI 0.41-1.19). Conclusion Short courses of a dual-strain probiotics appear to be effective in reducing NEC. ©2015 Foundation Acta Pædiatrica. Published by John Wiley & Sons Ltd.


PubMed | University of Zürich, Charité - Medical University of Berlin and Kinderkrankenhaus auf der Bult
Type: Journal Article | Journal: Acta paediatrica (Oslo, Norway : 1992) | Year: 2016

Prophylactic probiotics to reduce necrotising enterocolitis (NEC) are mostly given for at least 28 days or until discharge. We describe the effects of a shorter duration dosing strategy.Retrospective cohort study of neonates (birthweight 400-1500 g) in three neonatal intensive care units in Switzerland and Germany that embarked on probiotic prophylaxis given for 10 or 14 days, employing a fixed combination (Lactobacillus acidophilus plus Bifidobacterium infantis, each 10(9) CFU/day) licensed as a drug in Switzerland. Probiotics were initiated upon discontinuation of antibiotics, or on day 1-3 in infants without antibiotics. Repeat probiotic courses were given whenever antibiotics had been instituted and were discontinued.Birthweight and gestational age were similar in the two 24-month pre- and postimplementation cohorts. NEC rates fell from 33 of 633 (5.2%) to 8 of 591 infants alive at three days (1.4%; risk ratio (RR) 0.26, 95% confidence interval (CI) 0.12-0.55). The drop in NEC was significant both for infants of 400-999 g (6.4% to 2.5%) and 1000-1500 g birthweight (4.4% to 0.6%). Mortality was 5.1% (32/633) without, as opposed to 3.5% (21/591) with probiotics, respectively (RR 0.69, 95% CI 0.41-1.19).Short courses of a dual-strain probiotics appear to be effective in reducing NEC.


Sassmann H.,Hannover Medical School | de Hair M.,Hannover Medical School | Danne T.,Kinderkrankenhaus auf der Bult | Lange K.,Hannover Medical School
BMC Pediatrics | Year: 2012

Background: To assess initial efficacy and feasibility of a structured behavioural group training (DELFIN) for parents of children with diabetes type 1, in order to reduce parenting stress and to improve parenting skills.Methods: A randomized controlled study was conducted between July 2008 and September 2010, at a children's hospital in Hannover with parents of children with type 1 diabetes (2-10 yrs) (intervention group n = 37; control group n = 28). Parenting skills, parents' psychological burden, children's behavioural difficulties and quality of metabolic control were assessed before, 3 months after and 12 months after participating in the training program.Results: In the intervention group parenting behaviour in conflict situations improved significantly after 3 months (Z = -3.28; p ≤ 0.001). It remained stable over 12 months (Z = -2.94; p ≤ 0.01). Depression and anxiety scores of parents decreased (Z = -1.93; p ≤ .05; Z = -2.02; p ≤ .05). Even though the outcome in the intervention group was more positive, the differences between both study arms failed to reach statistical significance. Unexpectedly parenting behaviour in the control group improved also (Z = -2.45; p ≤ .05). Anxiety as well as stress scores decreased in this group (Z = -2.02; p ≤ .05 and Z = -2.11; p ≤ .05). In both groups the initial metabolic control was good and without significant differences (A1c 7.2±0.8% vs. 7.1±0.4%; p > 0.5). It remained stable in the DELFIN group (A1c 7.1±0.8%; p > 0.5), but it increased slightly in controls (A1c 7.3±0.5%; Z = -2.79; p = .005).Conclusions: This study has brought first evidence for the efficacy and feasibility of the program. A multicentre study with a larger sample is necessary to confirm these first results. © 2012 Saßmann et al.; licensee BioMed Central Ltd.


Long-term follow-up studies for extremely low birth weight (ELBW) infants or extremely preterm infants are important for quality management and to identify the perinatal and neonatal factors associated with adverse motor and cognitive outcomes. This study includes 200 ELBW infants born between 1993 and 1998 in a single institution. The mortality rate was low (14%). 79% of the survivors were assessed at the mean age of 8.4 years, which is a high rate. The results for the outcome at school age were correlated with peri- and postnatal parameters. 43% of the children survived without any impairment. Major impairment was diagnosed in 18% and minor impairment in 39% of the assessed children having special therapeutic needs. The following neonatal complications were significant risk factors for developing major or minor impairment at school age: an increase of head circumference <6 mm per week, parenteral nutrition ≥6 weeks and mechanical ventilation >14 days. One of these factors identifies an ELBW infant of risk with high sensitivity at discharge from the hospital.


Perl T.,University of Gottingen | Rhenius A.,University of Gottingen | Eich C.B.,Kinderkrankenhaus Auf der Bult | Quintel M.,University of Gottingen | And 2 more authors.
Central European Journal of Medicine | Year: 2012

Background: Perioperative hypothermia is rather common after head and neck surgery. Methods: In this prospective, randomised controlled study with 40 patients, we tested the hypothesis that the use of a new conductive warming system (PerfecTemp™, The Laryngeal Mask Company Limited, St. Helier, Jersey) in combination with insulation of 1.29 clo (treatment group) is better in reducing the incidence of hypothermia during and after head and neck surgery than insulation only (control group). Results: Repeated-measures analysis of variance (ANOVA) and post hoc Scheffé's test identifed a signifcantly higher core temperature in the treatment group at 45, 60, 75, 90, 105 and 120 min (p < 0.05). Furthermore, Fisher's exact test confrmed a lower incidence of intraoperative (3 vs. 9 patients; p = 0.03) and postoperative hypothermia (0 vs. 6 patients; p = 0.008). Conclusion: In conclusion, the combination of good thermal insulation and conductive warming is effective in preventing perioperative hypothermia during head and neck surgery. © Versita Sp. z o.o.


Deiss D.,Endokrinologikum Am Gendarmenmarkt | Diederich S.,Endokrinologikum Am Gendarmenmarkt | Kordonouri O.,Kinderkrankenhaus Auf der Bult
Deutsche Medizinische Wochenschrift | Year: 2011

History and clinical findings: A 22 year old obese woman with type 1 diabetes for 17 years and poor metabolic control despite continuous insulin infusion (case 1). Case 2 was a 16 year-old girl of normal weight in whom diabetes mellitus type 1 was diagnosed accidentally. Her 54 year old father was and had been treated for diabetes mellitus type 1 for 10 years. He was poorly controlled and associated with polyneuropathy and history of myocardial infarction (case 3). Investigations: In Case 1 the C-peptide test was negative, glutamic acid decarboxylase- and IA2-antibodies were not demonstrated. Cases 2 and 3 showed normal C-peptide, tests for GAD-, IA2- and ICA antibodies were negative. A nucleotid substitution in intron 1 of the HNF-4 gene was demonstrated. Treatment and course: All three patients were treated with liraglutide. There was a reduction in HbA1c, glucose fluctuations, hypoglycaemia, daily insulin dose and body weight, as well as an improvement of well-being and quality of life. Conclusion: These case reports indicate that GLP-1 analogs may reduce postprandial and fasting glucose levels in non-type 2 diabetic patients, independently or residual beta cell function. Further studies are needed to evaluate the benefits of treatment with liraglutide in patients with type 1 or type 3 diabetes. © Georg Thieme Verlag KG Stuttgart New York.


PubMed | Hannover Medical School and Kinderkrankenhaus auf der Bult
Type: Journal Article | Journal: European journal of pediatric surgery : official journal of Austrian Association of Pediatric Surgery ... [et al] = Zeitschrift fur Kinderchirurgie | Year: 2014

Fast-track concepts in pediatric surgery were established in a university hospital in consecutive studies within several years. They significantly reduced the length of hospitalization compared with German institutions without fast-track protocols. The aim of this study was to assess the implementation process of fast-track in a German nonacademic department of pediatric surgery without previous fast-track experience. All patients undergoing four types of operations (appendectomy, hypospadias repair, pyloromyotomy, and fundoplication) from February 2011 to January 2012 were included in this prospective study. Fast-track included detailed clinical pathways and specific pain treatment protocols using validated pain scales according to age. Mobilization and oral nutrition were started 2 hours postoperatively and documented with established scores. The length of hospital stay was compared with data from other hospitals with conventional treatment using information from the German reimbursement system (German diagnosis-related groups [G-DRG]) and with the hospital stay of patients from the corresponding university hospital undergoing fast-track treatment for the same procedures during the same study period. Two weeks after discharge, a questionnaire was completed by the patients/parents. A total of 143 patients with a mean age of 7.95.0 years underwent fast-track treatment. The mean pain intensity during the immediate postoperative period was 1.72.1 in patients<4 years and 2.32.1 in patients 4 years on a 10-point scale. Full mobilization was reached after a mean duration of 2.32.0 days while full oral nutrition was completed after a mean duration of 1.81.4 days. There were no complications associated with fast-track. The mean hospital stay was 5.83.4 days which was not significantly different compared with G-DRG data from other hospitals without fast-track. This was in contrast to the mean hospital stay of patients from the corresponding university hospital (5.63.0 days vs. G-DRG 6.93.2 days, p<0.05). After 2 weeks, patients/parents were highly satisfied with fast-track (mean score of 8.61.4 on a 1-10-point scale) and 95.2% claimed that they would choose it again. Fast-track concepts can be applied in a nonacademic department of pediatric surgery without previous fast-track experience and with excellent patient/parent satisfaction. However, the G-DRG system interferes with concepts of early discharge of patients. Modifications of the reimbursement modalities within the German health care system seem to be mandatory.

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