BACKGROUND: The underdevelopment of preterm infants can lead to delayed progression through key early milestones. Demonstration of safe oral feeding skills, constituting proper suck-swallow reflex are requirements for discharge from the neonatal intensive care unit (NICU) to ensure adequate nutrition acquisition. Helping an infant develop these skills can be draining and emotional for both families and healthcare staff involved in the care of preterm infants with feeding difficulties. Currently, there are no systematic reviews evaluating both family and healthcare team perspectives on aspects of oral feeding. Thus, we first aim to evaluate the current knowledge surrounding the perceptions, experiences and needs of families with preterm babies in the context of oral feeding in the NICU. Second, we aim to evaluate the current knowledge surrounding the perceptions, experiences and needs of healthcare providers (physicians, advanced practice providers, nurses, dietitians, speech-language pathologists and occupational therapists) in the context of oral feeding in the NICU.
METHODS: A literature search will be conducted in multiple electronic databases from their inception, including PubMed, CINHAL, Embase, the Cochrane Central Register for Controlled Trials and PsycINFO. No restrictions will be applied based on language or data of publication. Two authors will screen the titles and abstracts and then review the full text for the studies\' inclusion in the review. The data will be extracted into a pilot-tested data collection sheet by three independent authors. To evaluate the quality, reliability and relevance of the included studies, the Critical Appraisal Skills Programme checklist will be used. The overall evidence will be assessed using the Grading of Recommendation Assessment, Development and Evaluation criteria. We will report the results of the systematic review by following the Enhancing Transparency in Reporting the synthesis of Qualitative research checklist.
BACKGROUND: Ethical approval of this project is not required as this is a systematic review using published and publicly available data and will not involve contact with human subjects. Findings will be published in a peer-reviewed journal.
UNASSIGNED: CRD42023479288.

OBJECTIVE: To assess the efficacy, safety, immunogenicity, and pharmacokinetics through 240 weeks of ustekinumab treatment in paediatric patients from the long-term extension (LTE) of the phase 1, double-blind UniStar trial.
METHODS: Paediatric patients with moderately to severely active Crohn\'s disease (CD) were randomised 1:1 and stratified by body weight (<40 or ≥40 kg) to low- or high-dose intravenous ustekinumab followed by a subcutaneous maintenance dose at Week 8. At Week 16, patients were eligible to enter the LTE at the discretion of the investigator and continued maintenance dosing every 8 weeks up to Week 240.
RESULTS: Of the 34 patients who entered the LTE, 25 patients with evaluable data completed Week 48, and 41.2% (14/34) achieved clinical remission at Week 48. Among the 24 patients with Week-0 C-reactive protein (CRP) levels ≥3 mg/L, 29.2% (7/24) achieved normalisation of CRP at Week 48, while imputing missing data as failures. Through Week 240, the most common adverse events were infections (n = 28) and gastrointestinal disorders (n = 26). The most common serious adverse event was worsening of CD (n = 6). Only one patient had detectable antibodies to ustekinumab. Median serum ustekinumab concentrations remained consistent through Week 48, were detectable through Week 224, and trended lower in patients <40 kg.
CONCLUSIONS: Efficacy and pharmacokinetics through 1 year and safety and immunogenicity through 4 years of ustekinumab treatment in paediatric patients with CD were generally comparable to those previously reported in adults.

BACKGROUND: Gastrointestinal hospitalisations in the USA cause over US$130 billion in expenditures, and acute pancreatitis is a leading cause of these hospitalisations. Adequate pain control is one of the primary treatment goals for acute pancreatitis. Though opioids are commonly used for analgesia in these patients, there have been concerns about short-term and long-term side effects of using opioids. Recently, non-opioid medications have been studied to treat pain in patients with acute pancreatitis. This systematic review and network meta-analysis aims to assess the comparative efficacy of analgesic medication for non-severe, acute pancreatitis.
METHODS: We will search multiple electronic databases for randomised controlled trials that study pain management in patients with non-severe, acute pancreatitis. The intervention will be any analgesic for acute pancreatitis in the hospital setting. The comparison group will be patients who received a placebo or other active interventions for pain management. The primary outcomes of interest include pain scores and the need for supplementary analgesia. The secondary outcomes will be serious adverse events, local complications, progression to severe pancreatitis, transfer to the intensive care unit, length of hospitalisation, time to start enteral feeds, 30-day all-cause mortality and Quality of Life Scale scores. If sufficient homogeneity exists among included studies, the findings will be pooled using a traditional pairwise and network meta-analysis. The risk of bias in randomised control trials will be evaluated using the Cochrane Risk of Bias Tool 2.0. The Grading of Recommendations, Assessment, Development, and Evaluation approach will be used to report the certainty of evidence.
BACKGROUND: This systematic review will not involve direct contact with human subjects. The findings of this review will be published in a peer-reviewed journal. They will give healthcare providers a better awareness of the optimal analgesic medication for pain treatment in non-severe, acute pancreatitis.

BACKGROUND: The only biologic therapy currently approved to treat moderate to severe Crohn\'s disease in children (<18 years old) are those that antagonise tumour necrosis factor-alpha (anti-TNF). Therefore, it is critically important to develop novel strategies that maximise treatment effectiveness in this population. There is growing evidence that rates of sustained corticosteroid-free clinical remission, endoscopic healing and drug durability considerably improve when patients receive early anti-TNF dose optimisations guided by reactive or proactive therapeutic drug monitoring and pharmacodynamic monitoring. In response, our team has developed a personalised and scalable infliximab dosing intervention that starts with dose selection and continues throughout maintenance to optimise drug exposure. We hypothesise that a precision dosing strategy starting from induction and targeting dose-specific pharmacokinetic and pharmacodynamic endpoints throughout therapy will significantly improve outcomes compared with a conventional dosing strategy.
METHODS: Conduct a clinical trial to assess rates of deep remission between Crohn\'s disease patients receiving infliximab with precision dosing (n=90) versus conventional care (n=90). Patients (age 6-22 years) will be recruited from 10 medical centres in the USA. Each centre has been selected to provide either precision dosing or conventional care dosing. Precision dosing includes the use of a clinical decision support tool (RoadMAB) from the start of infliximab to achieve specific (personalised) trough concentrations and specific pharmacodynamic targets (at doses 3, 4 and 6). Conventional care includes the use of a modified infliximab starting dose (5 or 7.5 mg/kg based on the pretreatment serum albumin) with a goal to achieve maintenance trough concentrations of 5-10 µg/mL. The primary endpoint is year 1 deep remission defined as a combination of clinical remission (paediatric Crohn\'s disease activity index<10 (child) or a Crohn\'s disease activity index<150 (adults)), off prednisone>8 weeks and endoscopic remission (simple endoscopic severity-Crohn\'s disease≤2).
BACKGROUND: ). The study protocol has been approved by the Cincinnati Children\'s Hospital Medical Centre Institutional Review Board. Study results will be disseminated in peer-reviewed journals and presented at scientific meetings.
BACKGROUND: NCT05660746.

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OBJECTIVE: To evaluate the impact of mental health comorbidity in children and young adults with inflammatory bowel disease (IBD).
METHODS: Retrospective observational study.
METHODS: Representative population, routinely collected primary care data from the UK Optimum Patient Care Research Database (2015-2019).
METHODS: Patients with IBD aged 5-25 years with mental health conditions were compared with patients with IBD of the same age without mental health conditions.
METHODS: Outcomes comprised quality-of-life indicators (low mood, self-harm, parasuicide, bowel symptoms, absence from school or work, unemployment, substance use and sleep disturbance), IBD interventions (medication, abdominal surgery, stoma formation and nutritional supplements) and healthcare utilisation (primary care interactions and hospital admissions).
RESULTS: Of 1943 individuals aged 5-25 years with IBD, 295 (15%) had a mental health comorbidity. Mental health comorbidity was associated with increased bowel symptoms (adjusted incident rate ratio (aIRR) 1.82; 95% CI 1.33 to 2.52), sleep disturbance (adjusted HR (aHR) 1.63; 95% CI 1.02 to 2.62), substance use (aHR 3.63; 95% CI 1.69 to 7.78), primary care interactions (aIRR 1.33; 95% CI 1.12 to 1.58) and hospital admissions (aIRR 1.87; 95%CI 1.29 to 2.75). In individuals ≥18 years old, mental health comorbidity was associated with increased time off work (aHR 1.55; 95% CI 1.21 to 1.99).
CONCLUSIONS: Mental health comorbidity in children and young adults with IBD is associated with poorer quality of life, higher healthcare utilisation and more time off work. It is imperative that affected young patients with IBD are monitored and receive early mental health support as part of their multidisciplinary care.
BACKGROUND: The study protocol was specified and registered a priori (ClinicalTrials.gov study identifier: NCT05206734).

We assessed whether early-life diet quality and food intake frequencies were associated with subsequent IBD.
Prospectively recorded 1-year and 3-year questionnaires in children from the All Babies in Southeast Sweden and The Norwegian Mother, Father and Child Cohort Study were used to assess diet quality using a Healthy Eating Index and intake frequency of food groups. IBD was defined as >2 diagnoses in national patient registers. Cox regression yielded HRs adjusted (aHRs) for child\'s sex, parental IBD, origin, education level and maternal comorbidities. Cohort-specific results were pooled using a random-effects model.
During 1 304 433 person-years of follow-up, we followed 81 280 participants from birth through childhood and adolescence, whereof 307 were diagnosed with IBD. Compared with low diet quality, medium and high diet quality at 1 year of age were associated with a reduced risk of IBD (pooled aHR 0.75 (95% CI=0.58 to 0.98) and 0.75 (95% CI=0.56 to 1.00)). The pooled aHR per increase of category was 0.86 (0.74 to 0.99). Pooled aHR for children 1 year old with high versus low fish intake was 0.70 (95% CI=0.49 to 1.00) for IBD, and showed association with reduced risk of UC (pooled aHR=0.46; 95% CI=0.21, 0.99). Higher vegetable intake at 1 year was associated with a risk reduction in IBD. Intake of sugar-sweetened beverages was associated with an increased risk of IBD. Diet quality at 3 years was not associated with IBD.
In this Scandinavian birth cohort, high diet quality and fish intake in early life were associated with a reduced risk of IBD.

OBJECTIVE: Assessment of anthropometric data is essential for paediatric healthcare. We surveyed the implementation of European Society of Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) evidence-based guidelines and practical recommendations on nutritional care, particularly regarding anthropometric measurements.
METHODS: Paediatric hospitals from 28 European countries provided pseudonymized data through online questionnaires on hospital characteristics and their standards of nutritional care. Practical tasks assessed an unbiased collection and reporting of anthropometric measurements in random patients\' files and discharge letters.
RESULTS: Of 114 hospitals (67% academic), 9% have no nutritionist/dietitian available, 18% do not provide standard policy to assess weight and height and 15% lack training for nursing staff for accurate performance. A wall-mounted stadiometer to measure standing height and equipment for sitting weight is unavailable in 9% and 32%, respectively. Infant length is measured by one instead of two healthcare professionals and with a tape instead of a rigid length measuring board in 58% and 15% of hospitals, respectively. The practical tasks reviewed 1414 random patients, thereof 446 younger than 2 years of age. Missing documentation occurred significantly more often for height versus weight and their percentiles in infants ≤2 years versus older children, and in general paediatric versus gastrointestinal patients, with no difference between academic and nonacademic hospitals. Review of documented anthropometric data in discharge letters disclosed that consultants significantly underestimated the deficits in their units compared to documented data.
CONCLUSIONS: The survey revealed significant gaps in performance and documentation of anthropometry in the participating hospitals. A resurvey will assess changes in quality of care over time.

We examined literacy related to healthy gestational weight gain (GWG) in immigrant and native Japanese mothers and determined whether it is associated with children\'s birth weight.
Longitudinal cohort study.
As the baseline survey in the Japan Environment and Children\'s Study (JECS), mothers completed self-administered questionnaires distributed by hand during pregnancy. The self-administered questionnaires used in this study were distributed by mail 6 months after delivery. Children\'s birth weight, actual GWG and any complications during delivery were recorded by obstetricians collaborating with JECS.
Of 97 452 mothers who consented to participate in the JECS during pregnancy between January 2011 and March 2014, 67 953 were included in this study after exclusions for multiple births, multiple instances of consent by the same pregnant woman, miscarriages/stillbirths or withdrawal from the study within 3 years after participating. In total, 324 immigrant mothers and 963 native Japanese mothers were selected by propensity score matching for analysis.
Data were collected on maternal literacy related to healthy GWG at the baseline survey, and data on actual GWG and children\'s birth weight were collected by obstetricians. The associations of knowledge about healthy GWG and mothers\' actual GWG with maternal nativity status were examined using a χ2 or Student\'s t-test.
More native Japanese mothers than immigrant mothers knew the appropriate GWG and reason the for needing to know this. Actual GWG was significantly higher among the immigrant mothers, but was within the recommended range. The low birthweight (LBW) incidence was significantly higher among the native mothers.
Immigrant mothers to Japan had less knowledge about appropriate GWG, but their actual GWG was appropriate and they delivered fewer LBW infants than native Japanese mothers. These findings may indicate the presence of other protective factors for pregnancy or delivery among immigrant mothers.

Incidence of inflammatory bowel disease (IBD) is increasing in childhood and treatment increasingly targets mucosal healing. Monitoring bowel inflammation requires endoscopy or MRI enterography which are invasive, expensive and have long waiting lists.We aim to examine the feasibility of a non-invasive monitoring tool-bowel ultrasound (BUS)-in children with IBD and explore correlations with inflammatory markers and disease activity measures. Some BUS criteria have been found to correlate with these markers; however, this has not been validated in children.We aim to examine the feasibility of BUS for monitoring inflammation in this population; highlighting useful parameters for this purpose. We aim to inform a larger scale randomised controlled trial using BUS.
This prospective observational feasibility study will be carried out over 24 months at the Noah\'s Ark Children\'s Hospital for Wales, Cardiff; with the endpoint recruitment of 50 participants. Children aged 2-18 years with a modified Porto criteria diagnosis of IBD will be included.Patients without IBD or who have previously undergone IBD-related surgery will be excluded; as will families unable to give informed consent.Ultrasound scan images and reports will be collected, as well as laboratory results and clinical outcomes.The primary aim will assess the feasibility of targeted BUS for disease monitoring; including recruitment statistics. The secondary aims will involve data collection and correlation analysis for targeted ultrasound parameters, biomarkers, disease activity scores and prediction of changes in treatment. The statistical methods will include: feasibility metrics, descriptive statistics, cross-tabulation and χ2 analysis, correlation analysis, regression analysis.
Ethical approval is granted by NHS Research Ethics Committee. The sponsor is Cardiff and Vale University Health Board. We will publish the results in a peer-reviewed medical journal.
NCT05673278.