Development and Evaluation of a New Infant Nutrition Screening Tool
NCT ID: NCT03323957
Last Updated: 2017-10-27
Study Results
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Basic Information
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UNKNOWN
250 participants
OBSERVATIONAL
2010-10-01
2017-11-30
Brief Summary
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The purpose of this study is establish whether an infant Paediatric Yorkhill Malnutrition Score for infants would be able to distinguish infants who are well-nourished from those undernourished or at risk of undernutrition. The researchers will recruit all newly admitted patients ( 210 infants with low, medium, and high risk of undernutrition) from selected wards at the Royal Hospital for Sick Children Glasgow. The result from the infant screening tool will be compared with the rating using the longer Subjective Global Nutritional Assessment to test the ability of Infant Screening Tool to identify infants at high risk of malnutrition. The researcher will also measure the fat store using skinfolds and will compare the results among those rated high or low risk by the new tool. Finally, the utility of iPYMS score, growth trajectory, body mass index and behaviour questionnaire as predictors of low adiposity and stunting will be compared.
Detailed Description
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Recruitment The researcher will identify those patients eligible for screening by visiting the wards. The researcher will give an information leaflet to the patient's carer to introduce and explain the study. The researcher will allow plenty at least an hour for them to consider the study. The researcher will then approach the family and answer any questions. If the carer is happy to participate, the researcher will ask him/her to complete a consent form. A copy of the consent form will be given to the carers and another will be placed in the child's medical notes. The researcher will first complete the iPYMS scoring sheet for each child Discriminant validity will then be tested using body composition measurement using triceps (TSF) and subscapular skinfold thickness and the mid upper arm circumference (MUAC) and SGNA (Subjective Global Nutritional Assessment). To test the concurrent validity, the results from the infant screening tool will be compared with the results of STRONG kids (Screening Tool Risk on Nutritional Status and Grow).
Global Nutritional Assessment for infants (SGNA) The researcher will ask the main carers of patients to complete the eating behavior questionnaire about the infant's diet (type of milk. supplementary feeding and weaning diet), weight loss (poor weight gain), gastrointestinal symptoms,and daily activity. A rough visual assessment of the child's muscle stores and fat will be carried out by the researcher. This is a global nutritional assessment procedure recently validated in paediatric patients (Secker \& Jeejeebhoy, 2007). The researcher will extract equivalent items for SGNA about the child's food intake, diarrhoea, vomiting, weight loss or poor weight gain or no weight gain, during the few days before admission. An observational assessment of patients will be also carried out by the researcher in terms of diminished subcutaneous fat, muscle mass and hollow face (subjective clinical assessment the same as d). In addition, the researcher will use information recorded in the medical notes of the patient to assess patients' underlying illness with a risk of malnutrition (Anorexia nervosa, Celiac disease, Cystic fibrosis, cardiac disease, and trauma).
Infant EBQ This questionnaire has been developed using population data from a cohort study and is designed to identify infants at risk of weight faltering. This will be completed by the main carers of patients to assess the patient's general appetite and eating behaviour.
Bioelectrical impedance (BIA) This has been developed for assessment of nutritional status in children based on indices of lean and fat adjusted for body size. This study will explore whether this method is practical and effective in this young age range and how it relates to nutrition score.
Length of hospital stay as a secondary outcome will also be collected from hospital admissions statistics or through the notes. Patients' birth weight will be collected by the maternal report in order to calculate weight trajectory
Power Calculation 70 subjects in each group gives 80% power to detect a difference of 0.5 SD in any of the measures between any two of the groups. This study thus aim to recruit 210-250 subjects.
Analysis The data will be used to test the utility of PYMS score, growth trajectory, body mass index and behaviour questionnaire as predictors of low adiposity and stunting.
Conditions
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Study Design
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CASE_ONLY
CROSS_SECTIONAL
Study Groups
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Patients
all infants admitted for care
nutritional screening tool
screening of disease associated malnutrition in sick infants
Interventions
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nutritional screening tool
screening of disease associated malnutrition in sick infants
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients who have been transferred from neonatal units and critical care
12 Months
ALL
No
Sponsors
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National Health Service, United Kingdom
OTHER_GOV
University of Glasgow
OTHER
Responsible Party
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Dr Konstantinos Gerasimidis
Senior Lecturer in Clinical Nutrition
Locations
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New Lister Building, Glasgow Royal Infirmary
Glasgow, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Konstantinos Gerasimidis, BSc MSc PhD
Role: primary
References
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Gerasimidis K, Milani S, Tester A, Purcell O, Woodley C, Tsiountsioura M, Koulieri A, Zerva O, Loizou K, Rafeey M, Kontogianni M, Wright C. A multicentre development and evaluation of a dietetic referral score for nutritional risk in sick infants. Clin Nutr. 2019 Aug;38(4):1636-1642. doi: 10.1016/j.clnu.2018.08.017. Epub 2018 Sep 5.
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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10/S0709/45
Identifier Type: -
Identifier Source: org_study_id