Clinical outcome of a randomized controlled blinded trial of open versus laparoscopic Nissen fundoplication in infants and children.

OBJECTIVE: To compare the clinical outcome and endocrine response in children who were randomized to open or laparoscopic Nissen fundoplication using minimization. BACKGROUND: It is assumed that laparoscopic surgery is associated with less pain, quicker recovery and dampened endocrine response. Few randomized studies have been performed in children. METHODS: Parents gave informed consent, and this study was approved and registered (ClinicalTrials.gov Identifier: NCT00231543). Anesthesia, postoperative analgesia and feeding were standardized. Parents and staff were blinded to allocation. Blood was taken for markers of endocrine response. RESULTS: Twenty open and 19 laparoscopic patients were comparable with respect to age, weight, neurological status, and presence of congenital anomalies. Median time to full feeds was 2 days in both groups (P = 0.85); hospital stay was 4.5 days in the open group versus 5.0 days in the laparoscopic group (P = 0.57). Pain was adequately managed in both groups and there was no difference in morphine requirements. Median follow-up was 22 (range 12-34) months. Dysphagia, recurrence and need for redo fundoplication were not different between groups; retching was higher after open surgery (56% vs. 6%; P = 0.003). Insulin levels decreased at 24 hours, and was 54% lower (P = 0.02) after laparoscopy. Cortisol was elevated immediately postoperative, but was 42% lower (P = 0.02) after laparoscopy. CONCLUSIONS: There was no difference in the postoperative analgesia requirements and recovery. Laparoscopy decreased insulin levels to a greater extent, but caused less of a response in cortisol. Early postoperative outcome confirmed equal efficacy, but fewer children with retching after laparoscopy.

Peritoneal drainage or laparotomy for neonatal bowel perforation? A randomized controlled trial.

OBJECTIVE: To determine whether primary peritoneal drainage improves survival and outcome of extremely low birth weight (ELBW) infants with intestinal perforation. SUMMARY BACKGROUND DATA: Optimal surgical management of ELBW infants with intestinal perforation is unknown. METHODS: An international multicenter randomized controlled trial was performed between 2002 and 2006. Inclusion criteria were birthweight >or=1000 g and pneumoperitoneum on x-ray (necrotizing enterocolitis or isolated perforation). Patients were randomized to peritoneal drain or laparotomy, minimizing differences in weight, gestation, ventilation, inotropes, platelets, country, and on-site surgical facilities. Patients randomized to drain were allowed to have a delayed laparotomy after at least 12 hours of no clinical improvement. RESULTS: Sixty-nine patients were randomized (35 drain, 34 laparotomy); 1 subsequently withdrew consent. Six-month survival was 18/35 (51.4%) with a drain and 21/33 (63.6%) with laparotomy (P = 0.3; difference 12% 95% CI, -11, 34%). Cox regression analysis showed no significant difference between groups (hazard ratio for primary drain 1.6; P = 0.3; 95% CI, 0.7-3.4). Delayed laparotomy was performed in 26/35 (74%) patients after a median of 2.5 days (range, 0.4-21) and did not improve 6-month survival compared with primary laparotomy (relative risk of mortality 1.4; P = 0.4; 95% CI, 0.6-3.4). Drain was effective as a definitive treatment in only 4/35 (11%) surviving neonates, the rest either had a delayed laparotomy or died. CONCLUSIONS: Seventy-four percent of neonates treated with primary peritoneal drainage required delayed laparotomy. There were no significant differences in outcomes between the 2 randomization groups. Primary peritoneal drainage is ineffective as either a temporising measure or definitive treatment. If a drain is inserted, a timely "rescue" laparotomy should be considered. Trial registration number ISRCTN18282954; http://isrctn.org/

The Sonksen logMAR Test of Visual Acuity: I. Testability and reliability.

PURPOSE: To develop a standardized logMAR test of visual acuity for young children and establish testability and reliability. METHODS: Two thousand nine hundred ninety-one children, aged 2 to 8 years 6 months, from a population sample of 4671 were recruited from schools and preschool facilities and tested. Ability to name or match letters, accept occlusion, and achieve binocular single and binocular and monocular measures of linear visual acuity were recorded. Inter- and intratester reliability was assessed for a random selection of 215 children. RESULTS: Two thousand nine hundred seventy-four (99.4%) matched or named letters, 2966 (99%) achieved binocular single, 2940 (98%) achieved binocular linear, and 2807 (94%) achieved monocular linear (for both eyes) measures. Binocular linear measures were achieved in 50% aged less than 3 years, 80% aged 3 to 3(1/2), 92% aged 3(1/2) to 4, and 99% aged 4 years and over. Binocular linear measures were achieved in 86% of 2- to 3-year-olds and 96% of 3- to 3(1/2)-year-olds who matched or named letters; monocular linear measures were achieved in 86 and 95%, respectively, of these age groups who then accepted occlusion. The median time for completion of the test (binocular and monocular) was 3 minutes 55 seconds. The 95% limits of agreement for the same observer and for different observers were +/-0.13 and -0.19, +0.15 for binocular linear and -0.16, +0.15, and -0.17, +0.13 for monocular linear measures, respectively. CONCLUSIONS: The Sonksen logMAR Test provides reliable binocular and monocular measures of linear visual acuity in a high proportion of children from the age of 2.5 years.

Early severe neutropenia and thrombocytopenia identifies the highest risk cases of severe meningococcal disease.

OBJECTIVE: To determine the performance of established predictors of mortality in pediatric acute meningococcal disease (MD) in a contemporary population and to develop a simple predictive score that will not vary with observer. DESIGN: Prospective study for development set and mixed retrospective and prospective study for validation set. Setting and PATIENTS: A total of 227 patients with clinical meningococcal disease who were referred to three multidisciplinary pediatric intensive care units from 1993 to 1999. Early deaths before transfer to pediatric intensive care unit and deaths from cerebral herniation were included in the analysis. MEASUREMENTS AND MAIN RESULTS: The product of platelet and neutrophil counts at presentation (PN product) predicts mortality from meningococcal disease better than either count alone and at least as well as established severity scores. The Glasgow Meningococcal Septicaemia Prognostic Score and Malley scores performed poorly in these populations. The positive predictive value (PPV) for a Glasgow meningococcal septicemia prognostic score of >/=8/15 was 17.5% (16 of 91; 95% CI = 9%-25%), significantly lower than published estimates of 30%-74%, (p <.01). The PPV for death (or amputation) with a Malley score of 3/3 was 50% (12 of 24; 29%-71%), significantly lower than the published value of 100% (p <.001). The PN product appears to be a useful predictor. For a PN product of <40, PPV = 82% (9 of 11), specificity = 99% (195 of 197), and sensitivity = 73% (23 of 30). The performance of this score was greatest in younger children <5 yrs of age in whom clinical cerebral herniation was not seen as a cause of death (0 of 21 deaths at <5 yrs of age; 4 of 9 deaths at >/=5 yrs of age). CONCLUSION: Established scores significantly overestimate the occurrence of adverse outcomes in meningococcal disease. This may reflect improved resuscitation and outcome or variability in the application of these scores. The PN product achieves similar prediction to the scores currently in use and is independent of the observer. Factors that reflect the extent of the inflammatory response rather than the care before presentation are becoming increasingly important.

Pain and behaviour changes in children following surgery.

OBJECTIVES: To quantify postoperative pain and problematic behaviour (PB) in children at home following day-case (same day admission and discharge) or inpatient (≥1 night in hospital) surgery, to identify factors associated with PB at 2 and 4 weeks after discharge and to determine whether pain is associated with PB after adjustment for other factors. PATIENTS AND METHODS: Children scheduled for elective surgery were recruited to a descriptive study involving direct observation and self-report questionnaires. The principal outcomes were pain and PB on the 2nd post-discharge day and after the 1st, 2nd and 4th weeks. RESULTS: 131 parents and their children (aged 2-12years) participated in the study. 93% of children had pain and 73% exhibited PB on day 2 after discharge. The incidence of pain and PB decreased over time, but 25% of children still had pain and 32% PB at week 4. Factors associated with PB were child's previous pain experience, parent and child anxiety and parent's level of education. CONCLUSIONS: There was a high incidence of pain and PB persisting for several weeks after surgery in this cohort of children. Previous painful medical experiences and anxiety were important modifiable factors that require further attention from healthcare providers and researchers to potentially improve health and social outcomes for children after surgery.

The Sonksen logMAR test of visual acuity: II. Age norms from 2 years 9 months to 8 years.

PURPOSE: To establish age norms and interocular differences in visual acuity between 2 years 9 months and 8 years for the Sonksen logMAR Test. METHODS: Cross-sectional population-based study. Binocular measures of linear visual acuity were achieved in 2,940 children and monocular measures were achieved in 2,820 right eyes and 2,821 left eyes, respectively. Measures for both right and left eyes were achieved by 2,807. Asymmetric logistic models were used to construct smoothly changing age-related centile curves showing how visual acuity changes with age in a normative population sample. RESULTS: All curves demonstrated an increase in visual acuity with age that was steepest between 2 years 9 months and 5 years 3 months. Equivalent centiles for linear visual acuity were better when viewed binocularly than monocularly; the difference was least between the 95th centiles (best levels) and greatest between the 5th centiles (worst levels). There were no clinically significant differences between group measures of visual acuity from right and left eyes-average within child difference 0.0095 logMAR units, 95% CI, 0.0059-0.013. Interocular differences did not vary significantly with age (p = 0.73). The 90th and 95th centiles for interocular difference were 0.125 and 0.175 log units, respectively. CONCLUSIONS: This study demonstrates how visual acuity varied with age for the Sonksen logMAR Test and presents the findings in the clinically useful format of centile charts.

Accuracy of displayed values of tidal volume in the pediatric intensive care unit.

OBJECTIVES: To assess the accuracy of the expired tidal volumes (VT(E)) displayed by one of the most frequently used ventilators that measures exhaled volume at the expiratory valve. DESIGN: Prospective study. SETTING: The intensive care units of a pediatric tertiary referral center in London, UK. PATIENTS: A total of 56 intubated children aged between 3 wks and 16.6 yrs who were clinically stable and ventilated with a Servo 300 ventilator. INTERVENTIONS: The CO2SMO Plus respiratory monitor, which measures flow at the airway opening, was validated using calibrated syringes and appropriate tracheal tubes and connections. Simultaneous in vivo recordings of VT(E) from the Servo 300 and CO2SMO Plus were compared before (displayed Servo VT(E)) and after (effective Servo VT(E)) compensating for ventilator circuit compliance. MEASUREMENTS AND MAIN RESULTS: The in vitro accuracy of the CO2SMO Plus was within +/-5% over a wide range of volumes and measurement conditions. The displayed Servo 300 VT(E) overestimated the true VT(E) by between 2% and 91%. The magnitude of error varied within and between children, according to pressure change (peak inspiratory pressure minus positive end-expiratory pressure), VT(E), and circuit size. Mean (sd) error was 32% (20%) in 40 children with displayed Servo VT(E) of <160 mL and 18% (6%) in 16 subjects with displayed Servo VT(E) of >/=160 mL. After correcting for gas compression, effective VT(E) from the Servo 300 underestimated the true VT(E) by up to 64% in the smallest infants but continued to overestimate by as much as 29% in older children. CONCLUSIONS: The accuracy of tidal volume values is crucially dependent on the site of measurement. Unless measured at the airway opening, displayed values are an inconsistent and misleading indicator of the true volumes delivered.

The usefulness of renal vein renin studies in hypertensive children: a 25-year experience.

Lateralised renin secretion predicts improvement following surgery/angioplasty of the affected kidney in paediatric hypertension. We retrospectively analysed all our renal vein renin (RVR) studies undertaken in hypertensive children and their subsequent clinical outcomes over a 25-year period. The outcomes were categorised as cure, improvement or no change in hypertension. The proportions that benefited by 'following' or 'ignoring' the RVR results in relation to the aetiology of hypertension and subsequent therapy were compared. A ratio between the RVR value of the dominant kidney and that of the contralateral kidney (R/Rc ratio) above 1.5 was considered to show significant lateralisation. A ratio between RVR value of the contralateral kidney and that of the caudal inferior vena cava (Rc/P ratio) of less than 1.3 was considered to indicate contralateral renin suppression. Of 233 RVR records, 137 were suitable for analysis. Of these, 39 had reflux nephropathy (RN), 73 renovascular disease (RVD) and the others miscellaneous conditions. Of the 39 hypertensive children with RN, the R/Rc ratio was over 1.5 in 20 subjects, of whom 11 underwent surgery. Amongst the 19 with an R/Rc less than 1.5, 4 also had surgery. Of the 73 hypertensive children with RVD, the R/Rc ratio was over 1.5 in 38 subjects, of whom 20 underwent surgery/angioplasty. Amongst the 35 with an R/Rc less than 1.5, 7 also underwent surgery/angioplasty. In RN there was no significant difference in the proportion that improved with allocated treatment, as suggested by the 'test' when compared with those who were 'misallocated'. In RVD, however, the proportion improved (35.0%) by 'following the test' (i.e. R/Rc ratio) was significantly greater than the proportion improved (12.5%) in the group in whom the test was 'ignored'. This was true for both R/Rc and Rc/P ratios. Thus, RVR measurements are useful for identifying hypertensive children with RVD that may have a favourable outcome after surgery, but this does not apply to children with RN. Measurements, however, may have diagnostic value even if surgery or angioplasty is not anticipated.

Development of lung function in early life: influence of birth weight in infants of nonsmokers.

This study aimed to compare lung growth and development during the first year of life in healthy term infants of low or appropriate birth weight for gestation. Paired measurements of forced expiratory volume in 0.4 second, FVC, and forced expiratory flow when 75% of FVC has been exhaled were obtained, using the raised volume technique, at about 7 weeks and 9 months of age in 80 infants (32 low and 48 appropriate birth weight for gestation) of white, nonsmoking mothers. Forced flows and volumes increased with growth. Longitudinal trends in results were compared between the two groups, using random effects modeling and adjusted for potential confounding factors. After adjustment for sex, age, and length, forced expiratory volume was significantly reduced by an average (95% confidence interval) of 9% (2 to 16%) in low birth weight compared with appropriate birth weight for gestation infants throughout the first year of life, with a similar trend in forced expiratory flow (8% [-2 to 17%]) and FVC (4% [-3 to 11%]). These findings suggest that lung function is reduced in low birth weight for gestation infants born to nonsmoking white mothers and that this is independent of somatic growth during infancy.