The efficacy and safety of itopride in feeding intolerance of critically ill patients receiving enteral nutrition: a randomized, double-blind study.

BACKGROUND: Enteral feeding intolerance (EFI) is a frequent problem in the Intensive care unit (ICU) and is associated with poor clinical outcomes leading to worse prognosis in terms of mortality and ICU stay. Nowadays, prokinetic drugs are the mainstay of therapy in EFI. However, available prokinetics have uncertain efficacy and safety profiles. Itopride, is a prokinetic agent which is different and unique from the available prokinetics because of its dual mode of action as well as its tolerability and safety. The current study compared the efficacy and safety of Itopride against metoclopramide for EFI in critically ill patients. Moreover, it tested the utility and applicability of ultrasonography to measure gastric residual volume (GRV) in this population. METHODS: This randomized, double-blind study included 76 EFI patients who were randomly assigned to either Itopride or metoclopramide group. The primary outcome was to measure GRV by ultrasonography. Secondary outcomes included the percentage ratio of enteral feed volume, energy and protein received by patients over 7 days of treatment, ICU length of stay, safety parameters and occurrence of infectious complications or vomiting. RESULTS: Thirty-five patients of each group completed the study. At day 7, itopride significantly decreased GRV compared with metoclopramide group (p = 0.001). Moreover, there was a significant increase in the ratios of received enteral nutrition feed volume, calories, and protein after the one-week therapy in the itopride group more than the metoclopramide group (p = 0.001), (p = 0.002), (p = 0.01), respectively and there were no differences in any secondary outcomes or adverse events between the two groups. CONCLUSION: In critically ill patients with EFI, itopride was well tolerated with superior efficacy to metoclopramide. In addition, we demonstrated that ultrasonography is a simple, non-invasive, inexpensive, and undemanding method for GRV measurements and can offer reliable assessments in the gastric emptying modality. TRIAL REGISTRATION: The trial was registered in ClinicalTrials.gov (NCT03698292). Date: October 5, 2018.

Do young children consistently meet 24-h sleep and activity guidelines? A longitudinal analysis using actigraphy.

BACKGROUND: Existing studies examining adherence to 24-h movement guidelines in young children are mostly cross sectional and have not assessed additional guidelines relating to activity intensity or regularity in sleep patterns. The aims of this study were to determine adherence to full sleep, activity, and sedentary behaviour guidelines from 1-5 years of age, whether adherence tracked over time, and how adherence was related to body composition cross sectionally and prospectively. SUBJECTS/METHODS: Data were obtained from 547 children who were participants in a randomised controlled trial. At 1, 2, and 5 years of age, children wore Actical accelerometers 24-h a day for 5-7 days, height and weight were measured, and parents completed questionnaires on screen time and restraint (1 and 2 years only). A dual-energy x-ray absorptiometry (DXA) scan measured body composition at 5 years of age. RESULTS: Although adherence to general sleep and activity guidelines was high, few children had regular sleep patterns. Adherence to all three guidelines ranged from 12.3 to 41.3% at the different ages, although these estimates decreased to 0.6-9.3% when activity intensity (60 min of energetic play) and sleep regularity (consistent sleep and wake times) were included. Children who met all three guidelines at a given age were more likely to meet all three guidelines at a subsequent age (odds ratio, 95% CI: 2.6, 1.04-6.4 at 1 year and 2.5, 1.1-5.9 at 2 years). However, adherence to meeting all three guidelines at earlier ages was not related to BMI z-score or body composition at age 5, either cross sectionally or prospectively. CONCLUSIONS: Strategies to promote adherence to movement guidelines among young children are warranted, particularly to reduce screen time, and encouraging regular sleep patterns.

24-h movement behaviors from infancy to preschool: cross-sectional and longitudinal relationships with body composition and bone health.

BACKGROUND: New physical activity guidelines for children address all movement behaviors across the 24-h day (physical activity, sedentary behavior, sleep), but how each component relates to body composition when adjusted for the compositional nature of 24-h data is uncertain. AIMS: To i) describe 24-h movement behaviors from 1 to 5 years of age, ii) determine cross-sectional relationships with body mass index (BMI) z-score, iii) determine whether movement behaviors from 1 to 5 years of age predict body composition and bone health at 5 years. METHODS: 24-h accelerometry data were collected in 380 children over 5-7 days at 1, 2, 3.5 and 5 years of age to determine the proportion of the day spent: sedentary (including wake after sleep onset), in light (LPA) and moderate-to-vigorous physical activity (MVPA), and asleep (including naps). BMI was determined at each age and a dual-energy x-ray absorptiometry (DXA) scan measured fat mass, bone mineral content (BMC) and bone mineral density (BMD) at 5 years of age. 24-h movement data were transformed into isometric log-ratio co-ordinates for multivariable regression analysis and effect sizes back-transformed. RESULTS: At age 1, children spent 49.6% of the 24-h day asleep, 38.2% sedentary, 12.1% in LPA, and 0.1% in MVPA, with corresponding figures of 44.4, 33.8, 19.8 and 1.9% at 5 years of age. Compositional time use was only related significantly to BMI z-score at 3.5 years in cross-sectional analyses. A 10% increase in mean sleep time (65 min) was associated with a lower BMI z-score (estimated difference, - 0.25; 95% CI, - 0.42 to - 0.08), whereas greater time spent sedentary (10%, 47 min) or in LPA (10%, 29 min) were associated with higher BMI z-scores (0.12 and 0.08 respectively, both p < 0.05). Compositional time use from 1 to 3.5 years was not related to future BMI z-score or percent fat. Although MVPA at 2 and 3.5 years was consistently associated with higher BMD and BMC at 5 years, actual differences were small. CONCLUSIONS: Considerable changes in compositional time use occur from 1 to 5 years of age, but there is little association with adiposity. Although early MVPA predicted better bone health, the differences observed had little clinical relevance. TRIAL REGISTRATION: ClinicalTrials.gov number NCT00892983 .

Eating frequency in relation to BMI in very young children: a longitudinal analysis.

OBJECTIVE: Eating less frequently is associated with increased obesity risk in older children but data are potentially confounded by reverse causation, where bigger children eat less often in an effort to control their weight. Longitudinal data, particularly in younger children, are scarce. We aimed to determine whether eating frequency (meals and snacks) at 2 years of age is associated with past, current or subsequent BMI. DESIGN: Cohort analysis of a randomised controlled trial. Eating frequency at 2 years of age was estimated using 48 h diaries that recorded when each child ate meals and snacks (parent-defined) in five-minute blocks. Body length/height and weight were measured at 1, 2 and 3·5 years of age. Linear regression assessed associations between the number of eating occasions and BMI Z-score, before and after adjustment for potential confounding variables. SETTING: Prevention of Overweight in Infancy (POI) study, Dunedin, New Zealand. SUBJECTS: Children (n 371) aged 1-3·5 years. RESULTS: On average, children ate 5·5 (sd 1·2) times/d at 2 years of age, with most children (88-89 %) eating 4-7 times/d. Eating frequency at 2 years was not associated with current (difference in BMI Z-score per additional eating occasion; 95 % CI: -0·02; -0·10, 0·05) or subsequent change (0·02; -0·03, 0·06) in BMI. Similarly, BMI at age 1 year did not predict eating frequency at 2 years of age (difference in eating frequency per additional BMI Z-score unit; 95 % CI: -0·03; -0·19, 0·13). CONCLUSIONS: Number of eating occasions per day was not associated with BMI in young children in the present study.

Three-year follow-up of a randomised controlled trial to reduce excessive weight gain in the first two years of life: protocol for the POI follow-up study.

BACKGROUND: The Prevention of Overweight in Infancy (POI) study was a four-arm randomised controlled trial (RCT) in 802 families which assessed whether additional education and support on sleep (Sleep group); food, physical activity and breastfeeding (FAB group); or both (Combination group), reduced excessive weight gain from birth to 2 years of age, compared to usual care (Control group). The study had high uptake at recruitment (58 %) and retention at 2 years (86 %). Although the FAB intervention produced no significant effect on BMI or weight status at 2 years, the odds of obesity were halved in those who received the sleep intervention, despite no apparent effect on sleep duration. We speculate that enhanced self-regulatory behaviours may exist in the Sleep group. Self-regulation was not measured in our initial intervention, but extensive measures have been included in this follow-up study. Thus, the overall aim of the POI follow-up is to determine the extent to which augmented parental support and education on infant sleep, feeding, diet, and physical activity in the first 2 years of life reduces BMI at 3.5 and 5 years of age, and to determine the role of self-regulation in any such relationship. METHODS/DESIGN: We will contact all 802 families and seek renewed consent to participate in the follow-up study. The families have received no POI intervention since the RCT finished at 2 years of age. Follow-up data collection will occur when the children are aged 3.5 and 5 years (i.e. up to 3 years post-intervention). Outcomes of interest include child anthropometry, body composition (DXA scan), diet (validated food frequency questionnaire), physical activity (accelerometry), sleep (questionnaire and accelerometry), and self-regulation (questionnaires and neuropsychological assessment). DISCUSSION: Our follow-up study has been designed primarily to enable us to determine whether the intriguing benefit of the sleep intervention suggested at 2 years of age remains as children approach school age. However, cohort analyses will also investigate how BMI, self-regulation, and sleep consolidation develop during the early years. This information will be valuable to researchers and policy makers progressing the field of early childhood obesity prevention. TRIAL REGISTRATION: ClinicalTrials.gov number NCT00892983 .

Examining the accuracy of the New Zealand B4 School Check universal health service anthropometric measurements of children.

BACKGROUND: The aim of the current study was to determine whether anthropometric data from the New Zealand B4 School Check (B4SC) universal health service assessments are comparable to research grade anthropometric data. METHODS: B4SC anthropometric data were obtained for a subsample (n=394) of children who participated in the Prevention of Overweight in Infancy (POI) randomised control trial. B4SC anthropometric measures were compared to POI anthropometric values that had been interpolated to align with the date of the B4SC assessment. RESULTS: Interclass correlation coefficients between values from the two sources (0.93-0.98) suggested that across all these measures, most variation depended on between child effects rather than between source effects. A paired t-test found no evidence for differences between POI and B4SC height values. B4SC weights were a mean of 0.45kg heavier, and BMIs a mean of 0.41kg/m2 greater. Exploratory analyses demonstrated that greater overestimation of weight by the B4SC was associated with assessments on colder days. CONCLUSION: B4SC measurements of weight were greater than values obtained from interpolating the POI standardised research assessments. Interestingly, this overestimation was inversely associated with the average temperature on the day when the B4SC occurred. These findings suggest that universal health services that monitor growth in children could be improved by including standardised procedures to account for non-removal of clothing.

Dexmedetomidine versus Magnesium as Adjuvants to Bupivacaine-Induced Caudal Block in Children: A Randomized, Double-Blinded, Placebo-Controlled, Trial.

BACKGROUND: Caudal block remains fundamental in pediatric anaesthetic practice. It is very useful in a wide range of surgical procedures and has proved to have a remarkable safety record, But one of the major limitations of the single-injection technique is the relatively short duration of postoperative analgesia. Prolongation of caudal analgesia using single-shot technique has been achieved by the addition of various adjuvant. AIM: This work aims to compare magnesium and dexmedetomidine as adjuvants to bupivacaine-induced caudal block in children undergoing lower limb orthopaedic surgery. STUDY DESIGN: Randomized, double-blind trial. SETTINGS: Pediatric or of a tertiary care centre. METHODS: A double-blinded, randomised controlled trial included 36 children, aged between 1 and 7 years, scheduled for lower limb orthopaedic surgery. Patients received general anaesthesia in addition to the caudal block. Patients were divided into three groups: Dexmedetomidine group (n = 12): received 0.5 mL/Kg bupivacaine + 2 mcg/Kg dexmedetomidine, Magnesium group (n = 12): received 0.5 mL/Kg bupivacaine + 50 mg magnesium, and control group (n = 12): received 0.5 mL/Kg bupivacaine + normal saline. Patients were compared according to the duration of analgesia, pain scores, sedation scores, mean arterial pressure, and heart rate. RESULTS: Both magnesium group and dexmedetomidine group showed better analgesic profile (duration of analgesia and pain scores) compared to the control group without significant difference between the two former groups. Dexmedetomidine group showed higher sedation score, lower mean arterial pressure and lower heart rate compared to other groups. CONCLUSIONS: Both magnesium (50 mg) and dexmedetomidine (2 mcg/Kg) improved the analgesic profile of bupivacaine-induced caudal block in children. Dexmedetomidine administration was accompanied with higher sedation score and negative hemodynamic profile.

Sleep, nutrition, and physical activity interventions to prevent obesity in infancy: follow-up of the Prevention of Overweight in Infancy (POI) randomized controlled trial at ages 3.5 and 5 y.

Background: Our Prevention of Overweight in Infancy (POI) study suggested that a brief sleep intervention in infancy reduced the risk of obesity at age 2 y. In contrast, we observed no benefit from the nutrition and activity intervention. Objective: The objective of the study was to determine how these interventions influenced growth at ages 3.5 and 5 y compared with usual care (Control). Design: A follow-up of a parallel, 4-arm, single-blind, 2-y, randomized controlled trial in 802 women (86% European, 48% primiparous) recruited in pregnancy (58% response rate) was undertaken. All groups received standard Well-Child care with additional support for 3 intervention groups: FAB (promotion of breastfeeding, healthy eating, physical activity: 8 contacts, antenatal, 18 mo); Sleep (prevention of sleep problems: antenatal, 3 wk); Combination (both interventions). Follow-up measures were collected by staff blinded to group allocation. The primary outcome was child body mass index (BMI) z score, and secondary outcomes were prevalence of obesity (BMI ≥95th percentile), self-regulation (psychological measures), sleep, physical activity (accelerometry, questionnaires), and dietary intake (food-frequency questionnaire). Analyses were conducted through the use of multiple imputation. Results: Retention was 77% at age 3.5 y and 69% at age 5 y. Children in the FAB group had significantly higher BMI z scores than did Controls at age 5 y (adjusted difference: 0.25; 95% CI: 0.04, 0.47) but not at age 3.5 y (0.15; 95% CI: -0.04, 0.34). Children who received the Sleep intervention (Sleep and Combination groups) had significantly lower BMI z scores at age 3.5 y (-0.24; 95% CI: -0.38, -0.10) and at age 5 y (-0.23; 95% CI: -0.38, -0.07) than children who did not (Control and FAB groups). Conclusions: A conventional intervention had unexpected adverse long-term weight outcomes, whereas positive outcomes from a less conventional sleep intervention remained promising at age 5 y. More intensive or extended sleep intervention might have larger or longer-lasting effects and should be investigated. This trial was registered at clinicaltrials.gov as NCT00892983.

Targeting Sleep, Food, and Activity in Infants for Obesity Prevention: An RCT.

OBJECTIVE: The few existing early-life obesity prevention initiatives have concentrated on nutrition and physical activity, with little examination of sleep. METHODS: This community-based, randomized controlled trial allocated 802 pregnant women (≥16 years, <34 weeks' gestation) to: control, FAB (food, activity, and breastfeeding), sleep, or combination (both interventions) groups. All groups received standard well-child care. FAB participants received additional support (8 contacts) promoting breastfeeding, healthy eating, and physical activity (antenatal-18 months). Sleep participants received 2 sessions (antenatal, 3 weeks) targeting prevention of sleep problems, as well as a sleep treatment program if requested (6-24 months). Combination participants received both interventions (9 contacts). BMI was measured at 24 months by researchers blinded to group allocation, and secondary outcomes (diet, physical activity, sleep) were assessed by using a questionnaire or accelerometry at multiple time points. RESULTS: At 2 years, 686 women remained in the study (86%). No significant intervention effect was observed for BMI at 24 months (P = .086), but there was an overall group effect for the prevalence of obesity (P = .027). Exploratory analyses found a protective effect for obesity among those receiving the "sleep intervention" (sleep and combination compared with FAB and control: odds ratio, 0.54 [95% confidence interval, 0.35-0.82]). No effect was observed for the "FAB intervention" (FAB and combination compared with sleep and control: odds ratio, 1.20 [95% confidence interval, 0.80-1.81]). CONCLUSIONS: A well-developed food and activity intervention did not seem to affect children's weight status. However, further research on more intensive or longer running sleep interventions is warranted.

Impact of an early-life intervention on the nutrition behaviors of 2-y-old children: a randomized controlled trial.

BACKGROUND: Despite an extensive well-child health service, 30% of New Zealand's 2- to 4-y old children are overweight or obese. This suggests that additional intervention is necessary to establish healthy nutrition behaviors. OBJECTIVE: The aim of this study was to assess the effect of intervention from 0 to 18 mo of age on food and nutrient intake, eating behaviors, and parental feeding practices in 18- to 24-mo-old children. DESIGN: In total, 802 families with healthy infants were randomly allocated to 1 of 4 groups: Usual Care (UC); Food, Activity, and Breastfeeding (FAB); Sleep; or FAB and Sleep (Combination). All groups received standard "well-child" care. The FAB intervention comprised 7-8 additional contacts for education and support around breastfeeding, food, and activity. The Sleep intervention comprised 2 additional contacts for guidance about sleeping habits. Combination families received both interventions. A validated food-frequency questionnaire assessed food intake at 2 y. A questionnaire assessed eating behaviors and parental feeding practices at 18 and 24 mo. RESULTS: At 2 y, there were no statistically significant differences in food and nutrient intake or eating behaviors in the groups receiving the FAB intervention (FAB, Combination; 325 children) compared with the groups who did not (Sleep, UC; 341 children). With the use of a 5-point scale, small but statistically significant differences in parental feeding practices were observed in the groups receiving the FAB intervention: greater child control over eating (difference: 0.14; 95% CI: 0.02, 0.26) and less pressure to eat (difference: 0.18; 95% CI: 0.04, 0.32) at 18 mo, as well as greater encouragement of nutrient-dense foods at 24 mo (difference: 0.16; 95% CI: 0.03, 0.30). No statistically significant differences were observed between the groups who received the Sleep intervention (Sleep, Combination; 313 children) and those who did not, except higher meat intake in the former (11 g/d). CONCLUSION: Additional education and support for parents from birth did not improve nutrition behaviors in this population at 2 y of age. This trial was registered at clinicaltrials.gov as NCT00892983.