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Trial record 2 of 4 for:    S0709

Development and Evaluation of a New Infant Nutrition Screening Tool (iNEWS)

This study is currently recruiting participants.
Verified October 2017 by Dr Konstantinos Gerasimidis, University of Glasgow
Sponsor:
ClinicalTrials.gov Identifier:
NCT03323957
First Posted: October 27, 2017
Last Update Posted: October 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Health Service, United Kingdom
Information provided by (Responsible Party):
Dr Konstantinos Gerasimidis, University of Glasgow
  Purpose

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.


Condition Intervention
Malnutrition Paediatric Failure to Thrive Diagnostic Test: nutritional screening tool

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Development and Evaluation of a New Infant Nutrition Screening Tool

Resource links provided by NLM:


Further study details as provided by Dr Konstantinos Gerasimidis, University of Glasgow:

Primary Outcome Measures:
  • Mean skinfold z-score [ Time Frame: baseline ]
    The average of triceps (TSF) and subscapular skinfold thickness z-scores (SD) will be calculated as a measure of current nutritional status


Secondary Outcome Measures:
  • Hospital Stay [ Time Frame: The period in days from the date of hospital admission until the date of hospital discharge, assessed up to 100 days ]
    Length of Hospital Stay

  • Global Nutritional Assessment [ Time Frame: baseline ]
    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).


Estimated Enrollment: 250
Actual Study Start Date: October 1, 2010
Estimated Study Completion Date: November 30, 2017
Estimated Primary Completion Date: November 30, 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients
all infants admitted for care
Diagnostic Test: nutritional screening tool
screening of disease associated malnutrition in sick infants

Detailed 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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participant of the study will be all patients newly admitted to selected wards (medical and general surgical wards) at the Royal Hospital for Sick Children. An average of 8 patients per day are admitted to the relevant wards and we will aim to recruit a total of 250. Children aged 1 -12 months are the subjects of this study as the purpose of this study is to develop a screening tool for infants.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03323957


Contacts
Contact: Konstantinos Gerasimidis, BSc MSc PhD 1412018689 konstantinos.gerasimidis@glasgow.ac.uk
Contact: Charlotte Wright, MD MBBS charlotte.wright@glasgow.ac.uk

Locations
United Kingdom
New Lister Building, Glasgow Royal Infirmary Recruiting
Glasgow, United Kingdom, G31 2ER
Contact: Konstantinos Gerasimidis, BSc MSc PhD    1412018689    konstantinos.gerasimidis@glasgow.ac.uk   
Sponsors and Collaborators
University of Glasgow
National Health Service, United Kingdom
  Study Documents (Full-Text)

Documents provided by Dr Konstantinos Gerasimidis, University of Glasgow:
Study Protocol  [PDF] October 18, 2017

  More Information

Responsible Party: Dr Konstantinos Gerasimidis, Senior Lecturer in Clinical Nutrition, University of Glasgow
ClinicalTrials.gov Identifier: NCT03323957     History of Changes
Other Study ID Numbers: 10/S0709/45
First Submitted: October 18, 2017
First Posted: October 27, 2017
Last Update Posted: October 27, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: not allowed from the IPR approval to share data with third parties

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Malnutrition
Failure to Thrive
Nutrition Disorders
Signs and Symptoms