A randomised controlled trial of early insulin therapy in very low birth weight infants, "NIRTURE" (neonatal insulin replacement therapy in Europe)

Background

Studies in adult intensive care have highlighted the importance of insulin and improved glucose control on survival, with 32% reduction in mortality, 22% reduction in intensive care stay and halving of the incidence of bacteraemia. Very low birth weight infants requiring intensive care also have relative insulin deficiency often leading to hyperglycaemia during the first week of life. The physiological influences on insulin secretion and sensitivity, and the potential importance of glucose control at this time are not well established. However there is increasing evidence that the early postnatal period is critical for pancreatic development. At this time a complex set of signals appears to influence pancreatic development and β cell survival. This has implications both in terms of acute glucose control but also relative insulin deficiency is likely to play a role in poor postnatal growth, which has been associated with later motor and cognitive impairment, and fewer β cells are linked to risk of type 2 diabetes later in life.

Methods

A multi-centre, randomised controlled trial of early insulin replacement in very low birth weight babies (VLBW, birth weight < 1500 g). 500 infants will be recruited from 10 centres in the UK and Europe. Babies will be randomised to receive a continuous insulin infusion (0.05 units/kg/h) or to receive standard neonatal care from the first day of life and for the next 7 days. If blood glucose (BG) levels fall infants will receive 20% dextrose titrated to maintain normoglycaemia (4–8 mmol/l). If BG is consistently above 10 mmol/l babies will receive standard treatment with additional insulin infusion. The primary end point will be mortality on or before expected date of delivery, secondary end points will be markers of morbidity and include episodes of sepsis, severity of retinopathy, chronic lung disease and growth.

Trial Registration

Current Controlled Trials ISRCTN78428828. EUDRACT Number 2004-002170-34     

Krankenhausaufenthalt aus Patienten- und Angehörigensicht

Background

Surveys on patient satisfaction have become an important part of quality management within the healthcare system. In the pediatric field, it is especially important to question the relatives as well, as they are the patients’ legal guardians and the representatives entitled to speak up on their behalf.

Methods

From February to July 2003, two questionnaires (“Kinder-HFK” [Hamburg questionnaire on time in hospital — children] and “Jugend-HFK” [Hamburg questionnaire on time in hospital — adolescents]) were used in interviews with 247 patients and their relatives; the questionnaires deal with different aspects of being in hospital, and all patients were inpatients in either the Children’s Department or the Children’s Surgical Department of the University Hospital in Leipzig.

Results

In general, the patients’ time in hospital was seen in a positive light. However, it is possible to differentiate between different areas. The free comments recorded in the questionnaires illustrated the importance of “person-to-person interaction.” Most suggestions for improvements concerned the way the hospital routine was structured and organized.

Conclusions

These results will be used as the basis of specific action to improve satisfaction among pediatric inpatients and their relatives. Once these interventions have taken place, the survey will be repeated to check whether patients’ and relatives’ satisfaction is indeed higher.     

Prevalence of prediabetes in school-going children

Objective

To study the prevalence of prediabetes among school children in Mysore city.

Design

Cross sectional study.

Settings

Children aged 5–10 years from three schools in Mysore city were included. Study was done over a period of 1 year during 2006–2007.

Participants

726 children (59.8% males).

Main Outcome

Prevalence of prediabetes. Prediabetes was defined as fasting blood sugar level between 100–125 mg/dL.

Results

The prevalence of prediabetes was 3.7%. No statistically significant association was observed with major risk factors of diabetes.

Conclusions

Efforts must be made to recognize type 2 diabetes in the asymptomatic prediabetes state.     

INCLEN diagnostic tool for epilepsy (INDT-EPI) for primary care physicians: Development and validation

Objective

To evaluate the diagnostic accuracy of a new diagnostic instrument for epilepsy — INCLEN Diagnostic Tool for Epilepsy (INDT-EPI) — with evaluation by expert pediatric neurologists.

Study design

Evaluation of diagnostic test.

Setting

Tertiary care pediatric referral centers in India.

Methods

Children aged 2–9 years, enrolled by systematic random sampling at pediatric neurology out-patient clinics of three tertiary care centers were independently evaluated in a blinded manner by primary care physicians trained to administer the test, and by teams of two pediatric neurologists.

Outcomes

A 13-item questionnaire administered by trained primary care physicians (candidate test) and comprehensive subject evaluation by pediatric neurologists (gold standard).

Results

There were 240 children with epilepsy and 274 without epilepsy. The candidate test for epilepsy had sensitivity and specificity of 85.8% and 95.3%; positive and negative predictive values of 94.0% and 88.5%; and positive and negative likelihood ratios of 18.25 and 0.15, respectively.

Conclusion

The INDT-EPI has high validity to identify children with epilepsy when used by primary care physicians.     

Triglyceride and non-high-density lipoprotein cholesterol as predictors of cardiovascular disease risk factors in Chinese Han children

Objective

To investigate the role of serum cholesterol and triglyceride in the assessment of cardiovascular disease risk factors in children and adolescents.

Design

Case-control study.

Setting

Children’s Hospital of Zhejiang University School of Medicine, Hangzhou, China.

Subjects

Children from 6 years to 17 year old. 188 with simple obesity, and 431 with obesity and metabolic abnormalities. 274 age and gender-matched healthy children as controls.

Methods

Receiver operating characteristic curves were used to analyze the detection of cardiovascular disease risk factors by cholesterol and triglyceride in children and adolescents.

Results

The ranges of areas under receiver operating characteristic curves (AUC) for triglyceride and non-high-density lipoprotein cholesterol were 0.798–0.860 and 0.667–0.749, respectively to detect cardiovascular disease risk factors. The ranges of AUC for low-density lipoprotein cholesterol, total cholesterol, and high-density lipoprotein cholesterol were 0.631–0.718, 0.596–0.683, and 0.292–0.376, respectively.

Conclusions

Triglyceride and non-high-density lipoprotein cholesterol are better than low-density lipoprotein cholesterol as predictors of cardiovascular disease risk factors in Chinese Han children and adolescents.     

Locally-prepared ready-to-use therapeutic food for children with severe acute malnutrition: A controlled trial

Objective

To compare the efficacy of locally-prepared readyto-use therapeutic food (LRUTF) and locally-prepared F100 diet in promoting weight-gain in children with severe acute malnutrition during rehabilitation phase in hospital.

Study design

Non-randomized Controlled trial.

Setting

Pediatric ward of tertiary care public hospital in Central India.

Study period

1 October, 2009 to 30^th May, 2010.

Subjects

Children aged 6 to 60 months, diagnosed as severe acute malnutrition and hospitalized during study period.

Intervention

Random group allocation followed for selection of intervention and control cohorts. The control cohort enrolled during October 1, 2009 to January 31, 2010 received F100 while the intervention cohort enrolled during 1 February to 15 May 2010 received LRUTF. Subjects receiving either of the two therapeutic foods were temporally separated to minimize the spillover effect. The study subjects and the technician delegated for measuring weight was blinded for type of intervention.

Primary outcome variable

Rate of weight-gain/kg/day.

Results

There were 49 subjects in each group. Both groups were comparable. Rate of weight-gain was found to be (9.59±3.39 g/kg/d) in LRUTF group and (5.41 ± 1.05 g/kg/d) in locally prepared F100 group. Significant difference in rate of weight gain was observed in LRUTF group (P<0.0001; 95% CI 3.17–5.19). No serious adverse effect was observed with use of LRUTF.

Conclusion

LRUTF promotes more rapid weight-gain when compared with F100 in patients with severe acute malnutrition during rehabilitation phase.     

Robot-assisted resection of choledochal cysts and hepaticojejunostomy in children

Purpose

Choledochal cysts have traditionally been treated as an open procedure. However, recent publications from some large volume centres show that minimally invasive surgery has become their standard approach. Robotic surgical systems facilitate a surgeon’s ability to undertake complex procedures. We present our experience of using robot assistance to treat choledochal cysts.

Methods

Children admitted with a choledochal cyst from March 2009 to Nov 2012 were included. There were 27 patients (20 females). Mean age 5.4 years (range 0.3–15.9). Mean weight 21.9 kg (range 5.9–78.8); 10 weighed <10 kg. The choledochal cysts were types 1c(12), 1f(10) and 4(5). The da vinci Surgical System was used for the robot-assisted resection of the choledochal cyst and hepaticojejunostomy. Roux loop was fashioned extra-corporeally. Mean follow-up is 2.7 years (range 0.9–4.7).

Results

22 cases were completed successfully with robotic assistance. Five open conversions were for anatomical concerns or technical reasons. One child had three complications (omental hernia, anastomotic stricture and subsequent bile leak). Patients were on full feeds by a median of 5 days (range 3–6) and discharged after 6 days (range 4–7).

Conclusion

Robotic-assisted resection of choledochal cysts in children is safe. They made a rapid recovery with a good cosmetic outcome.     

Partizipation von 8- bis 12-jährigen Kindern mit Zerebralparese in Schleswig-Holstein

Aim of the study

Participation, defined as the ability to be involved in social situations in society, is an important outcome for children to maximize their development potential but little is known about the frequency of participation of disabled children. This study investigated how participation varied between children with cerebral palsy and the general population and how personal factors influenced the frequency of participation.

Methods

In this study children between 8 and12 years of age with diagnosed cerebral palsy, born in Schleswig-Holstein, a northern region in Germany were included and recruitment was through primary care physicians. Healthy school children from a number of regional schools in Schleswig-Holstein served as a collective for comparative data. Information was obtained on age, sex, social status and pain in all children and on the level of motor and cognitive impairment in children with cerebral palsy. To measure participation in everyday activities the ‘Frequency of Participation Questionnaire’ developed from the Life-H instrument was used.

Results

A total of 73 children with cerebral palsy and 1,092 school children participated in the study. Both groups were similar regarding age, sex and social status. Children with cerebral palsy suffered pain more often and more intensely. Children with cerebral palsy with pain and those with more severely impaired walking skills and cognitive abilities reported a lower participation in general. The ‘Frequency of Participation Questionnaire’ demonstrated significant differences in participation in 8 out of 14 questions, with less participation in 7 out of 8 tested activities for children with cerebral palsy independent of age or sex.

Conclusion

Children with cerebral palsy participated less frequently in many but not all areas of everyday life, compared with children from the general population.     

Management of children with severe acute malnutrition: Experience of Nutrition Rehabilitation Centers in Uttar Pradesh,India

Objective

To assess the effectiveness of facility-based care for children with severe acute malnutrition (SAM) in Nutrition Rehabilitation Centers (NRC).

Design

Review of data.

Setting

12 NRCs in Uttar Pradesh, India.

Participants

Children admitted to NRCs (Jan 1, 2010 — Dec 31, 2011).

Intervention

Detection and treatment of SAM with locally-adapted protocols.

Outcomes

Survival, default, discharge, and recovery rates.

Results

54.6% of the total 1,229 children admitted were boys, 81.6% were in the age group 6–23 months old, 86% belonged to scheduled tribes, scheduled castes, or other backward castes, and 42% had edema or medical complications. Of the 1,181 program exits, 14 (1.2%) children died, 657 (47.2%) children defaulted, and 610 (51.7%) children were discharged The average (SD) weight gain was 12.1 (7.3) g/kg body weight/day and the average (SD) length of stay was 13.2 (5.6) days. 206 (46.8%) children were discharged after recovery (weight gain ≥15%) while 324 (53.2%) were discharged, non-recovered (weight gain <15%)

Conclusions

NRCs provide life-saving care for children with SAM; however, the protocols and therapeutic foods currently used need to be improved to ensure the full recovery of all children admitted.     

Micronutrients deficiency and associated sociodemographic factors in Chinese children

Background

Although the prevalence of malnutrition has decreased, micronutrient deficiency still exists among children. While iron level has been studied, limited information on serum levels of zinc in Chinese children is available. This study aims to describe the status of micronutrients and its association with sociodemographic factors, and to assess associated risk factors.

Methods

A cross-sectional study was performed on 1375 Chinese preschool children. Venous blood samples were collected and analyzed for zinc and iron by atomic absorption spectrophotometry. Sociodemographic information was obtained from self-administered questionnaires given to the parents.

Results

The high prevalence of low serum zinc (38.2%) and iron (24.3%) was found. Children from rural preschools had the lowest zinc levels, whereas those from urban preschools had the lowest iron levels. Children living in small houses had the highest prevalence of low serum zinc (47.1%), and children from small families (≤3 persons) had a higher prevalence of low serum zinc than those from large families (41.8% vs. 34.1%).

Conclusions

Our findings in the recent socioeconomic development of China suggest the need for continuous monitoring of nutritional factors and highlight the importance of public health implication in preschool children even in developed regions.     

Risk factors for scholastic backwardness in children

Aim

To identify the risk factors for scholastic backwardness in children.

Participants

Children in the 6–12 year age group attending regular schools and referred to the child guidance clinic for scholastic backwardness.

Setting

Tertiary care hospital in South India.

Methods

Participants were compared with an age-and sexmatched group of children with good academic performance, to ascertain risk factors for scholastic backwardness.

Results

There were 75 boys and 35 girls in the study group. Among them 30 (27%) children had mental retardation, 39 (36%) had borderline intelligence and 12 (11%) had microcephaly. Undernutrition was noted in 36 (33%) children and 31 (28%) had stunted growth. 28 (26%) children had a history of chronic medical problems like epilepsy, bronchial asthma and congenital heart diseases. Visual, hearing and speech defects were present in 6 (6%), 5 (5%) and 12 (11%) children, respectively. Statistically significant differences were noted in the educational level and employment status of parents of children with scholastic backwardness and those with good academic performance.

Conclusion

Social and family factors have a significant influence on the academic functioning of children.     

Physical activity as a clinical tool in the assessment of malnutrition

Objective

To measure physical activity in children with wasting and to look for association between poor physical activity and wasting.

Methods

Physical activity was measured in 56 children with wasting, using Children’s Activity Rating Scale, and compared with age- and sex-matched controls.

Results

A significant association was found between poor physical activity and malnutrition as determined by weight-for-height Z Score <-2 (P=0.001) and midupper-arm circumference (P=0.002).

Conclusion

Physical activity can be used as clinical parameter to assess malnutrition.     

A randomized controlled trial: child life services in pediatric imaging

Background

Children undergoing procedures in pediatric health care facilities and their families have been shown to benefit from psychosocial services and interventions such as those provided by a Certified Child Life Specialist (CCLS). The comprehensive impact of a CCLS in a pediatric imaging department is well recognized anecdotally but has not been examined in a prospective or randomized controlled fashion.

Objective

We prospectively assessed the impact of a CCLS on parent satisfaction, staff satisfaction, child satisfaction, and parent and staff perceptions of child pain and distress in a pediatric imaging department.

Materials and methods

Eligible children between 1 and 12 years of age (n?=?137) presenting to the pediatric imaging department for an imaging procedure were randomly assigned to an intervention or control arm. Those assigned to the intervention received the comprehensive services of a CCLS. The control group received standard of care, which did not include any child life services. Quantitative measures of satisfaction and perception of child pain and distress were assessed by parents and staff using a written 5-point Likert scale questionnaire after the imaging procedure. Children 4 and older were asked to answer 3 questions on a 3-point scale.

Results

Statistically significant differences between the intervention and control groups were found in 19 out of 24 measures. Parents in the intervention group indicated higher satisfaction and a lower perception of their child’s pain and distress. Staff in the intervention group indicated greater child cooperation and a lower perception of the child’s pain and distress. Children in the intervention group indicated a better overall experience and less fear than those in the control group.

Conclusion

Child life specialists have a quantifiably positive impact on the care of children in imaging departments. Measures of parent satisfaction, staff satisfaction, child satisfaction, child pain and child distress are shown to be positively impacted by the services of a CCLS. These results have significant implications for hospitals striving to increase satisfaction, decrease costs and improve quality of care. In a health care landscape that is changing quickly and increasingly focused on the cost of care, future research should assess whether the core tenants of the child life profession support and contribute quantifiably to high-quality, cost-effective practices in health care.     

Percutaneous drainage of intra-abdominal abscess in children with perforated appendicitis

Background

Because the surgical management of perforated appendicitis remains controversial, percutaneous catheter drainage (PCD) has gained favor for managing periappendiceal abscess in hemodynamically stable children.

Objective

To determine the safety and effectiveness of PCD in children with perforated appendicitis and to identify any variables of prognostic value.

Materials &; methods

We retrospectively evaluated clinical data and imaging features for 33 children undergoing PCD for periappendiceal abscess from October 2006 to February 2010. Those with preprocedural CT studies were assigned to one of three risk categories based on imaging features.

Results

Appendectomy was successfully postponed for all patients. Our technical success rate was 87.9%, with three recurrences (two requiring repeat drainage, one managed conservatively) and one possible complication (enterocutaneous fistula formation). Children with large and diffuse abscesses had a 50% rate of technical failure, which was significantly increased when compared to children with large but localized abscesses (P?Conclusion PCD can be effective for managing perforated appendicitis in children. Children with large and ill-defined abscess might be at increased risk for complication or recurrence.     

Glycerin suppository for promoting feeding tolerance in preterm very low birthweight neonates: A Randomized Controlled Trial

Objective

To compare the efficacy of glycerin suppository versus no suppository in preterm very-low-birthweight neonates for improving feeding tolerance.

Design

Randomized controlled trial.

Setting

Level III neonatal unit from Mumbai, India.

Participants

50 very-low-birthweight (birth weight between 1000 to 1500 grams) preterm (gestational age between 28 to 32 weeks) neonates randomized to glycerine suppository (n=25) or no intervention (n=26).

Intervention

Glycerin suppository (1g) once a day from day-2 to day-14 of life or no suppository, along with intermittent oral feeds and standardized care.

Primary outcome

Time required to achieve full enteral feeds (180 mL/kg/d).

Results

Baseline characteristics of neonates like gestational age, birth-weight, gender and age at the time of introduction of feeds were comparable in both groups. The mean (SD) duration to reach full enteral feed was 11.90 (3.1) days in glycerin suppository group and was not significantly different (P=0.58) from control group, [11.33 (3.57) days]. Glycerin suppository group regained birth weight 2 days earlier than control group but this difference was not significant (P=0.16). There was no significant difference in duration of hospital stay or occurrence of necrotizing enterocolitis amongst the two study groups.

Conclusion

Once daily application of glycerin suppository does not accelerate the achievement of full feeds in preterm very-low-birthweight neonates.     

Paediatric urinary tract infections: a retrospective application of the National Institute of Clinical Excellence guidelines to a large general practitioner referred historical cohort

Background

The National Institute for Clinical Excellence (NICE) is a United Kingdom nondepartmental public body accountable to the Department of Health. Before the introduction of the NICE guidelines in the United Kingdom most children younger than 1 year of age had a urinary tract ultrasound, cyclic micturating cystourethrogram and dimercaptosuccinic acid scintigraphy, the latter delayed 6 months post infection. Children older than 1 year had a urinary tract ultrasound only, and further imaging if necessary.

Objective

Identify who would have been investigated had the NICE imaging strategy been used and who would not. Compare the diagnostic yield and patient outcome with the previous imaging protocol using our prospectively collected historical data.

Materials and methods

We applied the new imaging strategy to a historic cohort of 934 patients with a urinary tract infection (UTI) referred by general practitioners to a specialist children’s hospital between 1996 and 2002.

Results

Of the 934 patients referred, 218 would have been investigated according to the NICE guidelines. In total, there were 105 patients with abnormal imaging findings, and 44 of these (42%) would have been investigated under the NICE guidelines.

Conclusion

Applying the NICE guidelines to children presenting with UTI will reduce the number imaged by 77% and will lead to missed identification of 58% of imaging abnormalities in the group. The majority of these abnormalities may be important. While supporting conservative investigation protocols, we are concerned that many abnormalities might go undetected.     

INCLEN diagnostic tool for autism spectrum disorder (INDT-ASD): Development and validation

Objective

To develop and validate INCLEN Diagnostic Tool for Autism Spectrum Disorder (INDT-ASD).

Design

Diagnostic test evaluation by cross sectional design

Setting

Four tertiary pediatric neurology centers in Delhi and Thiruvanthapuram, India.

Methods

Children aged 2–9 years were enrolled in the study. INDT-ASD and Childhood Autism Rating Scale (CARS) were administered in a randomly decided sequence by trained psychologist, followed by an expert evaluation by DSM-IV TR diagnostic criteria (gold standard).

Main outcome measures

Psychometric parameters of diagnostic accuracy, validity (construct, criterion and convergent) and internal consistency.

Results

154 children (110 boys, mean age 64.2 mo) were enrolled. The overall diagnostic accuracy (AUC=0.97, 95% CI 0.93, 0.99; P<0.001) and validity (sensitivity 98%, specificity 95%, positive predictive value 91%, negative predictive value 99%) of INDT-ASD for Autism spectrum disorder were high, taking expert diagnosis using DSM-IV-TR as gold standard. The concordance rate between the INDT-ASD and expert diagnosis for’ ASD group’ was 82.52% [Cohen’s κ=0.89; 95% CI (0.82, 0.97); P=0.001]. The internal consistency of INDT-ASD was 0.96. The convergent validity with CARS (r = 0.73, P= 0.001) and divergent validity with Binet-Kamat Test of intelligence (r = ?0.37; P=0.004) were significantly high. INDT-ASD has a 4-factor structure explaining 85.3% of the variance.

Conclusion

INDT-ASD has high diagnostic accuracy, adequate content validity, good internal consistency high criterion validity and high to moderate convergent validity and 4-factor construct validity for diagnosis of Autistm spectrum disorder.     

?Ich bin zu dick!“

Background

Our study aimed at investigating to what extent the subjective assessment of weight deviates from the objectively measured body mass index (BMI).

Methods

With the help of bivariate analysis and logistic regression we analyzed the magnitude and pattern of a possible discrepancy between subjective and objective weight in male and female children and adolescents aged 11?C17 in Germany in order to identify influencing factors. This investigation was based on the German Health Interview and Examination Survey for Children and Adolescents (KiGGS). Special attention was given to children and adolescents who overestimated their weight.

Results

For 51% of the boys and girls examined in the age group 11?C17 perception of their weight corresponded with their BMI. However, 47.7% of girls and 31.1% of boys overestimated their weight. Apart from gender other factors influencing weight perception included type of school, social status, and parents?? weight (p<05).

Conclusion

Our results show that a large number of the children and adolescents examined overestimate their weight. Behavioral preventive measures should take this into account.     

Improving glycaemic control and life skills in adolescents with type 1 diabetes: A randomised, controlled intervention study using the Guided Self-Determination-Young method in triads of adolescents, parents and health care providers integrated into routine paediatric outpatient clinics

Background

Cleft lip and/or palate (CL/P) increase mortality and morbidity risks for affected infants especially in less developed countries. This study aimed at assessing the effects of systematic pediatric care on neonatal mortality and hospitalizations of infants with cleft lip and/or palate (CL/P) in South America.

Methods

The intervention group included live-born infants with isolated or associated CL/P in 47 hospitals between 2003 and 2005. The control group included live-born infants with CL/P between 2001 and 2002 in the same hospitals. The intervention group received systematic pediatric care between the 7^th and 28^th day of life. The primary outcomes were mortality between the 7^th and 28^th day of life and hospitalization days in this period among survivors adjusted for relevant baseline covariates.

Results

There were no significant mortality differences between the intervention and control groups. However, surviving infants with associated CL/P in the intervention group had fewer hospitalization days by about six days compared to the associated control group.

Conclusions

Early systematic pediatric care may significantly reduce neonatal hospitalizations of infants with CL/P and additional birth defects in South America. Given the large healthcare and financial burden of CL/P on affected families and the relatively low cost of systematic pediatric care, improving access to such care may be a cost-effective public policy intervention.

Trial Registration

ClinicalTrials.gov: NCT00097149