Meta AnalysisID 2987
水解和无乳糖配方与标准F75和F100比较治疗住院婴幼儿（0~59月龄）严重消瘦、水肿和/或生长迟缓伴喂养不耐受——系统评价方案
CRD42021289220
How effective is hydrolysed- and lactose-free feeds compared to standard F75 and F100 for the treatment of hospitalised infants and children with severe wasting, oedema and/or growth failure with feeding intolerance?
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Record Fields
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- Meta Analysis Id
- 2987
- Evidence Id
- 11545
- Core Evidence Id
- 11545
- Source Meta Analysis Id
- 2937
- Herb2 Meta Analysis Id
- HBMA002937
- Crd Id
- CRD42021289220
- Title
- Hydrolysed- and lactose-free feeds compared to standard F75 and F100 for the treatment of hospitalised infants and children (0-59 months of age) with severe wasting, oedema, and/or growth failure with feeding intolerance – protocol for a systematic review
- Review Question
- How effective is hydrolysed- and lactose-free feeds compared to standard F75 and F100 for the treatment of hospitalised infants and children with severe wasting, oedema and/or growth failure with feeding intolerance?
- Study Type Included
- Randomized controlled trials, and cluster randomised trials will be included in the systematic review. Open-label trials will be included provided that random allocation was applied. The potential bias introduced will be addressed through sensitivity analyses. In addition, non-randomised interventions, including a cohort design with an appropriate control, will be included.
- Condition Being Studied
- 45 million children younger than five years suffered from wasting in 2020; 14 million suffered from severe wasting. Severe malnutrition is caused by an interplay of poor food security, an insufficient diet, recurrent infections and disease. Associated with high mortality rates, children with severe malnutrition are burdened by impaired digestion and absorption, including atrophy of the villi, greater permeability of the gut mucosa, decreased pancreatic exocrine functioning, loss of digestive enzymes, secondary lactose intolerance, a decrease in colonic absorption and diarrhoea. These impairments contribute to carbohydrate, protein and fat malabsorption. The protective factors of the gastrointestinal tract (gut motility, cell immunity and antibody synthesis) are affected, causing pathogen overgrowth in the gastrointestinal tract resulting in diarrhoea. Considering the altered gastrointestinal functioning complicating nutritional management, feeding intolerance is to be regarded as a crucial marker of gastrointestinal dysfunction, including upper gastrointestinal symptoms, bowel movement frequency, abdominal distention and pain, bowel sounds and gastric residual volume in the case of enteral feeding. Considering the pathophysiology of children with severe malnutrition, poor tolerance to feeds, including that of F-75 and F-100, is probable.
- Participant
- Infants and/or young children (0-59 months) hospitalised for growth faltering/failure severe wasting (defined as a weight-for-length/ height z-score of less than -3 of the WHO child growth standards or a MUAC < 115mm) and/or oedema will be included in the study.
- Animal
- Human Disease Modelled
- Intervention
- Interventions will include hydrolysed- and lactose-free feeds, and this will be compared with standard F-75 and F-100. All other nutritional inventions, including polymeric feeds and foods, will be excluded for the purpose of this review.
- Comparator Control
- Comparators will include F-75 and F-100.
- Main Outcome
- To prevent misleading results, we will utilise denominators for the outcomes based on the intention to treat analysis. Subgroup analyses will be conducted at different time points. The following outcomes will be evaluated: • Feeding intolerance [vomiting, diarrhoea or abdominal distention; the absence of bowel sounds and gastric residual volume] • Clinical deterioration as defined by the development of any danger signs (e.g. obstructed breathing, respiratory distress, cyanosis, shock, severe anaemia, conclusion, severe dehydration, profuse watery diarrhoea, vomiting and/ or impaired consciousness) • Mortality • Duration and intensity of osmotic diarrhoea • Duration of nil per os and intravenous fluids used • Weight change • Duration of hospital stay or time to discharge Measures of effect Relative risks, odds ratios will be used. Where appropriate, forest plots will be used to summarise data that are reported as risk ratios or odds ratios, but a meta-analysis will not be performed. Continuous outcomes will be reported as arithmetic means and standard deviations and compared using mean difference (MD), and binary (dichotomous) outcomes using the risk ratio (RR) or risk difference (RD). Counts of outcome events will be summarised as rate ratios. Where outcome data are reported as geometric means, data will be combined on the log scale and reported as median and ranges. All results will be reported with 95% confidence intervals (CI). For eligible non-randomised intervention studies, we will additionally extract the unadjusted estimates or raw data and compare adjusted and crude estimates. We will conduct meta-analyses of both maximally adjusted estimates and minimally adjusted or crude estimates.
- Outcome Measure
- Additional Outcome
- • Feeding intolerance [vomiting, diarrhoea or abdominal distention; the absence of bowel sounds and gastric residual volume] • Clinical deterioration as defined by the development of any danger signs (e.g. obstructed breathing, respiratory distress, cyanosis, shock, severe anaemia, conclusion, severe dehydration, profuse watery diarrhoea, vomiting and/ or impaired consciousness) • Mortality • Duration and intensity of osmotic diarrhoea • Duration of nil per os and intravenous fluids used • Weight change • Duration of hospital stay or time to discharge Measures of effect Relative risks, odds ratios will be used. Where appropriate, forest plots will be used to summarise data that are reported as risk ratios or odds ratios, but a meta-analysis will not be performed. Continuous outcomes will be reported as arithmetic means and standard deviations and compared using mean difference (MD), and binary (dichotomous) outcomes using the risk ratio (RR) or risk difference (RD). Counts of outcome events will be summarised as rate ratios. Where outcome data are reported as geometric means, data will be combined on the log scale and reported as median and ranges. All results will be reported with 95% confidence intervals (CI). For eligible non-randomised intervention studies, we will additionally extract the unadjusted estimates or raw data and compare adjusted and crude estimates. We will conduct meta-analyses of both maximally adjusted estimates and minimally adjusted or crude estimates.
- Study Method
- Intervention, Meta-analysis, Systematic review
- Keyword
- Child; Diarrhea; Edema; Humans; Infant
- Contact
- Martani Lombard [email protected]
- Organisational Affiliation
- North-West University
- Funding Source
- The review was sponsored by the WHO.
- Other Selection Criteria
- Final Publication
- Same Topic Review
- None that we are aware of.
- Published Protocol
- https://www.crd.york.ac.uk/PROSPEROFILES/289220_PROTOCOL_20211103.pdf
- Review Type
- Language
- English
- Country
- South Africa
- Review Stage
- Review Ongoing
- First Submission Date
- 2021-11-03
- Registration Date
- 2021-12-04
- Anticipated Start Date
- 2021-11-20
- Anticipated Completion Date
- 2021-12-31
- Title Cn
- 水解和无乳糖配方与标准F75和F100比较治疗住院婴幼儿（0~59月龄）严重消瘦、水肿和/或生长迟缓伴喂养不耐受——系统评价方案
- Title En
- Hydrolysed- and lactose-free feeds compared to standard F75 and F100 for the treatment of hospitalised infants and children (0-59 months of age) with severe wasting, oedema, and/or growth failure with feeding intolerance – protocol for a systematic review
- Bilingual Status
- complete