Development and Evaluation of a New Infant Nutrition Screening Tool

Malnutrition Clinical Trial

— iNEWS  

Official title:

Development and Evaluation of a New Infant Nutrition Screening Tool

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03323957
• Other study ID #: 10/S0709/45
• Status: Recruiting
• Phase: N/A
• First received: October 18, 2017
• Last updated: October 26, 2017
• Start date: October 1, 2010
• Est. completion date: November 30, 2017

Study information

• Verified date: October 2017
• Source: University of Glasgow
• Contact: Konstantinos Gerasimidis, BSc MSc PhD
• Phone: 1412018689
• Email: konstantinos.gerasimidis[@]glasgow.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A large number of children experience undernutrition related to or resulting from their illness. The NHS has recently published standards which state that all patients should be screened for undernutrition on admission and periodically during their stay at hospital. Although, recent studies have attempted to develop appropriate nutritional screening tool for children on admission, there is no agreement concerning the most appropriate criteria to be used and they have not been validated for use in infants. The project team have developed a preliminary tool that would be both simple and quick to use in order to identify infants who are either undernourished or at risk of undernutrition on admission and who would benefit from referral for full nutritional assessment by a dietician.

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.

Description:

Subjects Participant of the study will be all patients newly admitted to selected wards at the Royal Hospital for Sick Children (and possibly RAH Paisley). An average of 8 patients per day are admitted to the relevant wards and this study will aim to recruit a total of 200 over a 4 month period, after an initial pilot with up to 20 patients.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: November 30, 2017
• Est. primary completion date: November 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 12 Months

Eligibility

Inclusion Criteria:

• All infant patients admitted to hospital overnight or longer on medical and general surgical wards

Exclusion Criteria:

• Patients in the short stay ward, intensive care or high dependency unit, oncology unit, critical care and cardiology

• Patients who have been transferred from neonatal units and critical care

Related Conditions & MeSH terms

• Failure to Thrive
• Malnutrition
• Paediatric Failure to Thrive

Intervention

Diagnostic Test:
• nutritional screening tool
screening of disease associated malnutrition in sick infants

Locations

Country	Name	City	State
United Kingdom	New Lister Building, Glasgow Royal Infirmary	Glasgow

Sponsors (2)

Lead Sponsor	Collaborator
University of Glasgow	National Health Service, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean skinfold z-score	The average of triceps (TSF) and subscapular skinfold thickness z-scores (SD) will be calculated as a measure of current nutritional status	baseline
Secondary	Hospital Stay	Length of Hospital Stay	The period in days from the date of hospital admission until the date of hospital discharge, assessed up to 100 days
Secondary	Global Nutritional Assessment	Global Nutritional Assessment for infants (Subjective Global Nutritional Assessment) as a measure of current and future nutrition risk (well-nourished, moderately malnourished, or severely malnourished).	baseline