In newly diagnosed paediatric patients with moderate-to-severe Crohn's disease (CD), infliximab (IFX) is initiated once exclusive enteral nutrition (EEN), corticosteroid and immunomodulator therapies ...have failed. We aimed to investigate whether starting first-line IFX (FL-IFX) is more effective to achieve and maintain remission than conventional treatment.
In this multicentre open-label randomised controlled trial, untreated patients with a new diagnosis of CD (3-17 years old, weighted Paediatric CD Activity Index score (wPCDAI) >40) were assigned to groups that received five infusions of 5 mg/kg IFX at weeks 0, 2, 6, 14 and 22 (FL-IFX), or EEN or oral prednisolone (1 mg/kg, maximum 40 mg) (conventional). The primary outcome was clinical remission on azathioprine, defined as a wPCDAI <12.5 at week 52, without need for treatment escalation, using intention-to-treat analysis.
100 patients were included, 50 in the FL-IFX group and 50 in the conventional group. Four patients did not receive treatment as per protocol. At week 10, a higher proportion of patients in the FL-IFX group than in the conventional group achieved clinical (59% vs 34%, respectively, p=0.021) and endoscopic remission (59% vs 17%, respectively, p=0.001). At week 52, the proportion of patients in clinical remission was not significantly different (p=0.421). However, 19/46 (41%) patients in the FL-IFX group were in clinical remission on azathioprine monotherapy without need for treatment escalation vs 7/48 (15%) in the conventional group (p=0.004).
FL-IFX was superior to conventional treatment in achieving short-term clinical and endoscopic remission, and had greater likelihood of maintaining clinical remission at week 52 on azathioprine monotherapy.
ClinicalTrials.gov Registry (NCT02517684).
IMPORTANCE: Individual gut-directed hypnotherapy (HT) is effective in pediatric irritable bowel syndrome (IBS) and functional abdominal pain or functional abdominal pain syndrome (FAPS). It is, ...however, unavailable to many children. OBJECTIVE: To compare the effectiveness of HT by means of home-based self-exercises using a CD with that of individual HT (iHT) performed by qualified therapists. DESIGN, SETTING, AND PARTICIPANTS: This noninferiority randomized clinical trial with a follow-up of 1 year after the end of treatment was conducted from July 15, 2011, through June 24, 2013, at 9 secondary and tertiary care centers throughout the Netherlands. A total of 303 children were eligible to participate. Of those, 260 children (aged 8-18 years) with IBS or FAP(S) were included in this study. Children were randomized (1:1 ratio) to home-based HT with a CD (CD group) or iHT performed by qualified therapists (iHT group). No children withdrew from the study because of adverse effects. INTERVENTIONS: The CD group was instructed to perform exercises 5 times per week or more for 3 months. The iHT group consisted of 6 sessions during 3 months. MAIN OUTCOMES AND MEASURES: Primary outcomes were treatment success directly after treatment and after 1-year follow-up. Treatment success was defined as a 50% or greater reduction in pain frequency and intensity scores. The noninferiority limit was set at 50% treatment success in the CD group, with a maximum of 25% difference in treatment success with the iHT group after 1-year follow-up. Modified intention-to-treat analyses were performed. RESULTS: A total of 132 children were assigned to the CD group and 128 to the iHT group; 250 children were analyzed (126 in the CD group and 124 in the iHT group) (mean SD age, 13.4 2.9 years in the CD group and 13.3 2.8 years in the iHT group; 94 female 74.6% in the CD group and 85 68.5% in the iHT group). Directly after treatment, 46 children (36.8%) in the CD group and 62 (50.1%) in the iHT group were successfully treated. After 1-year follow-up, the 62.1% treatment success in the CD group was noninferior to the 71.0% in the iHT group (difference, −8.9%; 90% CI, −18.9% to 0.7%; P = .002). CONCLUSIONS AND RELEVANCE: Long-term effectiveness of home-based HT with a CD is noninferior to iHT performed by therapists in pediatric IBS or FAP(S). Treatment with hypnosis using a CD provides an attractive treatment option for these children. TRIAL REGISTRATION: trialregister.nl Identifier: NTR2725
ABSTRACT
Objectives:
A potential link between small intestinal bacterial overgrowth (SIBO) and abdominal pain–related functional gastrointestinal disorders (AP‐FGID) has been suggested by symptom ...similarities and by the reported prevalence of SIBO in children with irritable bowel syndrome (IBS) and functional AP. The aim of this study is to evaluate the prevalence of SIBO using the glucose hydrogen breath test (GHBT), in a cohort of Dutch children with AP‐FGID fulfilling the Rome III criteria, and to identify potential predictors.
Methods:
Children ages 6 to 18 years with AP‐FGID fulfilling the Rome III criteria were included. All of the children underwent a GHBT. SIBO was diagnosed if the fasting breath hydrogen concentration was ≥20 ppm or an increase in H2 levels of ≥12 ppm above the baseline value was measured after ingestion of glucose. Gastrointestinal symptoms were collected using a standardised AP questionnaire.
Results:
A total of 161 Dutch children with AP‐FGID were enrolled. Twenty‐three patients (14.3%) were diagnosed as having SIBO, as assessed by GHBT; 78% of the children diagnosed as having SIBO had fasting hydrogen levels ≥20 ppm. IBS was significantly more found in children with SIBO compared with children without SIBO (P = 0.001). An altered defecation pattern (ie, change in frequency or form of stool) (P = 0.013), loss of appetite (P = 0.007), and belching (P = 0.023) were significantly more found in children with SIBO compared with those without SIBO.
Conclusions:
SIBO is present in 14.3% of children presenting with AP‐FGID. IBS, altered defecation pattern, loss of appetite, and belching were predictors for SIBO in children with AP‐FGID.
The potential effectiveness of gut-directed hypnotherapy (HT) is unknown for pediatric chronic nausea. This randomized controlled trial compared HT with standard medical treatment (SMT).
One hundred ...children (ages, 8–18 y) with chronic nausea and fulfilling functional nausea (FN) or functional dyspepsia (FD) criteria were allocated randomly (1:1) to HT or SMT, with a 3-month intervention period. Outcomes were assessed at baseline, at the halfway point, after treatment, and at the 6- and 12-month follow-up evaluation. Children scored nausea symptoms in a 7-day diary. The primary outcome was treatment success, defined as a reduction in nausea of 50% or more, at the 12-month follow-up evaluation. Secondary outcomes included adequate relief of nausea.
After treatment and at the 6-month follow-up evaluation, there was a trend toward higher treatment success in the HT group compared with the SMT group (45% vs 26%, P = .052; and 57% vs 40%, P = .099, respectively). At 12 months, treatment success was similar in both groups (60% in the HT group and 55% in the SMT group; P = .667). In the FN group, significantly higher success rates were found for HT, but no differences were found in patients with FD. Adequate relief was significantly higher in the HT group than in the SMT group at the 6-month follow-up evaluation (children: 81% vs 55%, P = .014; parents: 79% vs 53%; P = .016), but not at the 12-month follow-up evaluation.
HT and SMT were effective in reducing nausea symptoms in children with FN and FD. In children with FN, HT was more effective than SMT during and after the first 6 months of treatment. Therefore, HT and SMT, applied separately or in combination, should be offered to children with FN as a treatment option (Clinical trials registration number: NTR5814).
Recent attempts to translate Sepsis-3 criteria to children have been restricted to PICU patients and did not target children in emergency departments (ED). We assessed the prognostic accuracy of the ...age-adjusted quick Sequential Organ Failure Assessment score (qSOFA) and compared the performance to SIRS and the quick Pediatric Logistic Organ Dysfunction-2 score (qPELOD-2). We studied whether the addition of lactate (qSOFA-L) would increase prognostic accuracy.
Non-academic, single-center, retrospective study in children visiting the ED and admitted with suspected bacterial infection between March 2013 and January 2018. We defined suspected bacterial infection as initiation of antibiotic therapy within 24 h after ED entry. Age-adjusted qSOFA, SIRS, qPELOD-2, and qSOFA-L scores were compared by area under the receiver operating characteristics curve (AUROC) analysis. Primary outcome measure was PICU transfer and/or mortality and secondary outcome was prolonged hospital length of stay.
We included 864 ED visits 474 (55%) male; median age 2.5 years; IQR 9 months-6 years, of which 18 were transferred to a PICU and 6 ended in death composite outcome PICU transfer and/or mortality; 23 admissions (2.7%). 179 (22.2%) admissions resulted in prolonged hospital length of stay. PICU transfer and/or death was present in 22.5% of visits with qSOFA≥2 (
= 40) compared to 2.0% of visits with qSOFA<2 (
= 444) (
< 0.01). qSOFA tends to be the best predictor of PICU transfer and/or mortality (AUROC 0.72 (95% CI, 0.57-0.86) compared to SIRS 0.64 (95% CI, 0.53-0.74),
= 0.23 and qPELOD-2 0.60 (95% CI, 0.45-0.76),
= 0.03). Prolonged hospital length of stay was poorly predicted by qSOFA (AUROC 0.53, 95% CI 0.46-0.59), SIRS (0.49, 95% CI 0.44-0.54), and qPELOD-2 (0.51, 95%CI 0.45-0.57). qSOFA-L resulted in an AUROC of 0.67 (95% CI, 0.50-0.84) for PICU transfer and/or mortality and an AUROC of 0.56 (95% CI, 0.46-0.67) for prolonged hospital length of stay.
The currently proposed bedside risk-stratification tool of Sepsis-3 criteria, qSOFA, shows moderate prognostic accuracy for PICU transfer and/or mortality in children visiting the ED with suspected bacterial infection. The addition of lactate did not improve prognostic accuracy. Future prospective studies in larger ED populations are needed to further determine the utility of the qSOFA score.
Although disease-associated undernutrition is still an important problem in hospitalized children that is often underrecognized, follow-up studies evaluating post-discharge nutritional status of ...children with undernutrition are lacking. The aim of this multicentre prospective observational cohort study was to assess the rate of acute undernutrition (AU) and/or having a high nutritional risk (HR) in children on admission to seven secondary-care level Dutch hospitals and to evaluate the nutritional course of AU/HR group during admission and post-discharge. STRONG
was used to indicate HR, and AU was based on anthropometric data (
-score < -2 for weight-for-age (WFA; <1 year) or weight-for-height (WFH; ≥1 year)). In total, 1985 patients were screened for AU/HR over a 12-month period. On admission, AU was present in 9.9% of screened children and 6.2% were classified as HR; 266 (13.4%) children comprised the AU/HR group (median age 2.4 years, median length of stay 3 days). In this group, further nutritional assessment by a dietitian during hospitalization occurred in 44% of children, whereas 38% received nutritional support. At follow-up 4-8 weeks post-discharge, 101 out of orginal 266 children in the AU/HR group (38%) had available paired anthropometric measurements to re-assess nutrition status. Significant improvement of WFA/WFH compared to admission (-2.48 vs. -1.51 SD;
< 0.001) and significant decline in AU rate from admission to outpatient follow-up (69.3% vs. 35.6%;
< 0.001) were shown. In conclusion, post-discharge nutritional status of children with undernutrition and/or high nutritional risk on admission to secondary-care level pediatric wards showed significant improvement, but about one-third remained undernourished. Findings warrant the need for a tailored post-discharge nutritional follow-up.
In this retrospective cohort study, the response to routinely administered Haemophilus influenzae type B vaccine, pneumococcal and pertussis vaccinations in 27 children exposed to antitumor necrosis ...factor alpha (anti-TNFα) during pregnancy was measured. The overall vaccination response seems comparable for children exposed to anti-TNFα and healthy infants. After primary vaccination series, inadequate response was present in some patients and might be related to exposure to anti-TNFα.
Thioguanine (TG) has been shown as a safe alternative in adults with inflammatory bowel disease (IBD) who did not tolerate conventional thiopurines azathioprine (AZA)/mercaptopurine. However, data in ...pediatric IBD are scarce. Therefore, we aimed to assess the safety of TG as maintenance therapy.
A retrospective, multicenter cohort study of children with IBD on TG was performed in the Netherlands. TG-related adverse events (AE) were assessed and listed according to the common terminology criteria for AE.
Thirty-six children with IBD (median age 14.5 years) on TG (median dose 15 mg/day) were included in 6 centers. Five AE occurred during follow-up pancreatitis (grade 3), hepatotoxicity (grade 3) (n = 2), Clostridium difficile infection (grade 2), and abdominal pain (grade 2). All patients (n = 8) with a previously AZA-induced pancreatitis did not redevelop pancreatitis on TG.
In pediatric IBD, TG seems a safe alternative in case of AZA-induced pancreatitis. Further research assessing long-term TG-related safety and efficacy is needed.
Correspondence to Mrs Marjolijn Landman, Pediatrics, Maasstad Ziekenhuis, Rotterdam 3079 DZ, The Netherlands; LandmanM@maasstadziekenhuis.nl We evaluated the effect of the 2012 The European Society ...for Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) guideline and the diagnostic algorithm on coeliac disease diagnosis in children in the South West region of the Netherlands. A total of 253 children (median age 6.6 years; 154 girls 59%), were included. n=229 children had symptoms suggestive of coeliac disease, and n=24 had no symptoms and were screened based on family history presence of an associated condition. ...implementation of the 2012 ESPGHAN guideline resulted in a 54% reduction in the number of endoscopies needed to diagnose coeliac disease, indicating that diagnosis of coeliac disease can be made without histology in a significant number of children.
Background
In youth with inflammatory bowel disease (IBD), health-related quality of life (HRQOL) has been shown to be affected by individual disease factors and specific psychological factors. The ...innovative aim of this study is to examine the
combined
impact of psychological factors (illness perceptions, cognitive coping, anxiety, and depression) on HRQOL, over and above the associations of demographic and disease factors with HRQOL in youth with IBD.
Method
Data on clinical disease activity, illness perceptions, cognitive coping, anxiety, depression, and HRQOL were prospectively collected in 262 consecutive youth (age 10–20, 46.6% male) with confirmed IBD. Multiple linear regression analyses tested the associations of demographic, disease, and psychological variables with HRQOL in separate groups for Crohn’s disease (CD;
N
= 147) and ulcerative colitis and IBD unclassified (UC/IBD-U;
N
= 115), using age-specific validated instruments.
Results
In both disease groups, more negative illness perceptions (
ß
= − .412;
ß
= − .438,
p
< .001) and more depression (
ß
= − .454;
ß
= − .279,
p
< .001) were related to lower HRQOL. In the UC/IBD-U group, more anxiety was related to lower HRQOL (
ß
= − .201,
p
= .001). The model with the psychological variables explained a large and significant amount of variance in both groups: 74% and 83%, respectively (
p
< .001).
Conclusion
In 10–20-year-old IBD patients, negative illness perceptions and depression were significantly and more strongly associated with lower HRQOL than demographic and disease factors. Thus, it is important to integrate psychological factors in the treatment for IBD patients. To improve HRQOL in young IBD patients, psychological interventions should be targeted at negative illness perceptions and depression.
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