MalnutritioniNEWSNCT03323957
Development and Evaluation of a New Infant Nutrition Screening Tool
An observational study of Malnutrition and Paediatric Failure to Thrive, run by University of Glasgow at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages Up to 12 months
- Conditions the study is for
- Malnutrition, Paediatric Failure to Thrive
- What is being tested?
- nutritional screening tool
- How many people
- 250 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Oct 2010to 30 Nov 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 12 months
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- All infant patients admitted to hospital overnight or longer on medical and general surgical wards
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Charlotte Wright, MD MBBS contact
United Kingdom1 site, 1 recruiting
- Recruiting
New Lister Building, Glasgow Royal Infirmary
Glasgow, G31 2ER
Konstantinos Gerasimidis, BSc MSc PhD, 1412018689, konstantinos.gerasimidis@glasgow.ac.uk
About this study
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.
Read the 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.
- Conditions
- Malnutrition, Paediatric Failure to Thrive
- Being tested
- nutritional screening tool
- Medical subject headings
- Malnutrition, Failure to Thrive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nutritional screening toolDiagnostic test
screening of disease associated malnutrition in sick infants
| Study group | Role | What they receive |
|---|---|---|
| Patients | all infants admitted for care Receives: Diagnostic Test: nutritional screening tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline
Secondary outcomes (2)
Hospital Stay
Length of Hospital Stay
Measured: The period in days from the date of hospital admission until the date of hospital discharge, assessed up to 100 days
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).
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2017
- Study start1 Oct 2010
- Primary completion30 Nov 2017 (estimated)
- Study completion30 Nov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Glasgow
- Sponsor type
- University, hospital or other
- Collaborators
- National Health Service, United Kingdom
- Responsible party
- Principal investigator, Dr Konstantinos Gerasimidis, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03323957
- Sponsor's protocol ID
- 10/S0709/45
- Acronym
- iNEWS
- Status last verified
- Oct 2017
- First submitted
- 18 Oct 2017
- Last updated
- 27 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: not allowed from the IPR approval to share data with third parties
Publications
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.
PubMed 30224303
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of a New Infant Nutrition Screening Tool
- ClinicalTrials.gov ID
- NCT03323957
- Acronym / sponsor ID
- iNEWS / 10/S0709/45
- Conditions
- Malnutrition, Paediatric Failure to Thrive
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University of GlasgowUniversity, hospital or other
- Collaborators
- National Health Service, United Kingdom
- Study start
- 1 Oct 2010 (actual)
- Primary completion
- 30 Nov 2017 (estimated)
- Study completion
- 30 Nov 2017 (estimated)
- First posted
- 27 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Diagnostic Test: nutritional screening toolall infants admitted for care |
Who may qualify
- Ages
- Up to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- All infant patients admitted to hospital overnight or longer on medical and general surgical wards
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nutritional screening toolscreening of disease associated malnutrition in sick infants | Diagnostic test | Patients |
Primary outcome
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
2 secondary outcomes
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
Global Nutritional Assessment
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2017.
- Derived from this study: PubMed 30224303Gerasimidis 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.
- Individual participant dataSharing planned: No. not allowed from the IPR approval to share data with third parties
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charlotte Wright, MD MBBS contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malnutrition and Paediatric Failure to Thrive, run by University of Glasgow at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Konstantinos Gerasimidis, BSc MSc PhD (1412018689, konstantinos.gerasimidis@glasgow.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean skinfold z-score (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03323957, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2017.