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Nutrition Disorder, ChildNCT04862728

Role of Nutritional Intervention in Critically Ill Child

An observational study of Nutrition Disorder, Child, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Assess the nutritional status of critically ill children using different nutritional assessment tools in management. Assess accuracy and validity of screening tools in diagnosis of malnutrition by the following: Strong kids Stamp PYMS Assess the effect of early versus late enteral nutrition on the outcome and predict… Read more about this study

Who is it for?
Ages 1 year to 5 years
Conditions the study is for
Nutrition Disorder, Child
What is being tested?
- Strong kids screening tool - Stamp screening tool - PYMS screening tool
How many people
100 participants
Where
No sites listed yet
Study dates
Jun 2021to Sep 2022
How long will I take part?
1 Year
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 1 year to 5 years
  • All sexes
  • No healthy volunteers
  • Child

Study population: Study population will be taken from pediatric intensive care unit (PICU) at Assiut university Children Hospital.

Who may be able to join

  • Critically ill children aged 1-5 years admitted to PICU.

Who cannot join

  • Infants before the age of one year and children after the age of five years.
  • Any child with chronic illness.
  • Patients with multiorgans failure.
  • Children with congenital anomalies.
  • Children on renal dialysis.

Trial locations and contacts

No sites are listed yet.

Hanan Hamdallah contact

00201011540871

drsmart8989@gmail.com

About this study

Official title: Role of Various Nutritional Interventions in Management of Critically Ill Child

  • Assess the nutritional status of critically ill children using different nutritional assessment tools in management.
  • Assess accuracy and validity of screening tools in diagnosis of malnutrition by the following:
  • Strong kids
  • Stamp
  • PYMS
  • Assess the effect of early versus late enteral nutrition on the outcome and predict the complication associated with enteral feeding.
Read the detailed description

Malnutrition affects millions of children throughout the World. According to ESPEN nutritional risk screening tools have been designed to detect protein and energy under nutrition and predict if under nutrition may develop or worsen. The Screening was validated Tool for Assessment of Malnutrition in Pediatrics (STAMP) that evaluates patient's clinical diagnosis, nutritional intake during hospitalization and anthropometric measurements, developing a care plan based on the child's overall malnutrition risk. The Screening Tool for Impaired Nutritional Status and Growth (STRONG kids) consists of four items: clinical assessment, high-risk diseases, nutritional intake and losses, weight loss or poor weight gain.

The Pediatric Yorkhill Malnutrition Score (PYMS) is adopted among patients between 1 and 16 years of age assesses four items: BMI, history of recent weight loss, changes in nutritional intake and the expected effect of current medical condition on patient's nutritional status.

Indirect calorimetry, calculated from analysis of the inspired and expired gases, is the best method for evaluating individual energy expenditure.

Protein requirements are highe. The catabolic effects of illness lead to negative nitrogen balance. Randomized protein-supplemented enteral diet achieved 3.1g/kg/day protein and positive nitrogen balance by PICU day 5.

Enteral nutrition is more physiological, simpler, can be started more quickly and cheaper, it does not require special preparation, and it can be started and modified at any time.

Par enteral nutrition has reserved for those patients with intestinal obstruction or severe gastrointestinal damage, ischemia, inflammation, hemorrhage, peritonitis and paralytic ileus.

Being tested
- Strong kids screening tool - Stamp screening tool - PYMS screening tool
Medical subject headings
Child Nutrition Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • - Strong kids screening tool - Stamp screening tool - PYMS screening toolOther

    Also called early versus late enteral nutrition on the outcome and predict complication.

    Screening Tool for the Assessment of Malnutrition in Pediatrics (STAMP) evaluates patient's clinical diagnosis, nutritional intake during hospitalization and anthropometric measurements, developing a care plan based on the child's overall malnutrition risk (low, medium or high).Screening Tool for Impaired Nutritional Status and Growth (STRONG kids). It consists of four items: subjective clinical assessment, high-risk diseases, nutritional intake and losses, weight loss or poor weight gain. Patients classified at high nutritional risk have a longer hospitalization and a negative standard deviation score (SDS) for weight-for-height (WFH), which indicated a state of acute malnutrition.The Pediatric Yorkhill Malnutrition Score (PYMS) is adopted among medical and surgical patients between 1 and 16 years of age. The PYMS assesses four items: BMI, history of recent weight loss,

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Identifying high risk group of malnutrition among patient in PICU by nutritional assesement by Screening Tool for the Assessment of Malnutrition in Pediatrics.

    Screening Tool for the Assessment of Malnutrition in Pediatrics evaluates patient's clinical diagnosis nutritional intake during hospitalization and anthropometric measurements malnutrition risk. the measured value of the child's height and weight will recorded and compared to reference values by age. and gender

    Measured: baseline

  2. Identifying high risk group of malnutrition among patient in PICU by nutritional assesement by Screening Tool for Impaired Nutritional Status and Growth in kids.

    Screening Tool for Impaired Nutritional Status and Growth (STRONG kids) consists of subjective clinical assessment high risk diseases nutritional intake and losses. weight, poor weight gain Patients classified at high nutritional risk have a longer hospitalization and a negative standard deviation score for weight for height which indicated a state of acute malnutrition,this tool appeared rapid and easy to use, additionally it may predict long of hospital stay and identifies a need for nutritional interventions during the hospitalization.

    Measured: baseline

  3. Identifying high risk group of malnutrition among patient in PICU by nutritional assesement by The Pediatric Yorkhill Malnutrition Score.

    The Pediatric Yorkhill Malnutrition Score (PYMS) is adopted among patients between 1 and 16 years of age. It assesses BMI history of recent weight loss changes in nutritional intake and the expected effect of current medical condition on patient's nutritional status

    Measured: baseline

Secondary outcomes (1)

  1. the importance of early versus late enteral nutrition for patient in PICU.

    We will conduct this study to compare early (6-24 h) with late (after 24 h) initiation of enteral feeding in PICU. Enteral nutrition is more physiological,early enteral nutrition has a trophic effect on the intestinal mucosa, and stimulates the intestinal immune system, decreasing bacterial overgrowth and translocation; it therefore reduces the incidence of sepsis and multiorgan failure. Furthermore,early enteral nutrition is associated with fewer hepatic and metabolic complications than late and parentral nutrition.

    Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Apr 2021
  2. Study startJun 2021 (estimated)
  3. Primary completionJun 2022 (estimated)
  4. Study completionSep 2022 (estimated)

Resources

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
Other
Time perspective
Prospective
Enrolment
100 participants (estimated)
Target duration
1 Year
IDs, dates and publications
ClinicalTrials.gov ID
NCT04862728
Sponsor's protocol ID
malnutrition in critically ill
Status last verified
Apr 2021
First submitted
17 Apr 2021
Last updated
28 Apr 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Hulst JM, Zwart H, Hop WC, Joosten KF. Dutch national survey to test the STRONGkids nutritional risk screening tool in hospitalized children. Clin Nutr. 2010 Feb;29(1):106-11. doi: 10.1016/j.clnu.2009.07.006. Epub 2009 Aug 13.

    PubMed 19682776

  • Gerasimidis K, Keane O, Macleod I, Flynn DM, Wright CM. A four-stage evaluation of the Paediatric Yorkhill Malnutrition Score in a tertiary paediatric hospital and a district general hospital. Br J Nutr. 2010 Sep;104(5):751-6. doi: 10.1017/S0007114510001121. Epub 2010 Apr 19.

    PubMed 20398432

  • McCarthy H, Dixon M, Crabtree I, Eaton-Evans MJ, McNulty H. The development and evaluation of the Screening Tool for the Assessment of Malnutrition in Paediatrics (STAMP(c)) for use by healthcare staff. J Hum Nutr Diet. 2012 Aug;25(4):311-8. doi: 10.1111/j.1365-277X.2012.01234.x. Epub 2012 May 9.

    PubMed 22568534

  • Joosten KF, Hulst JM. Nutritional screening tools for hospitalized children: methodological considerations. Clin Nutr. 2014 Feb;33(1):1-5. doi: 10.1016/j.clnu.2013.08.002. Epub 2013 Aug 31.

    PubMed 24050847

  • Skillman HE, Wischmeyer PE. Nutrition therapy in critically ill infants and children. JPEN J Parenter Enteral Nutr. 2008 Sep-Oct;32(5):520-34. doi: 10.1177/0148607108322398.

    PubMed 18753390

Questions about this trial

What is this clinical trial studying?

An observational study of Nutrition Disorder, Child, run by Assiut University.

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 5 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 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

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 Hanan Hamdallah (00201011540871, drsmart8989@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Identifying high risk group of malnutrition among patient in PICU by nutritional assesement by Screening Tool for the Assessment of Malnutrition in Pediatrics. (time frame: baseline). The study lists 3 primary outcomes in all. 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 NCT04862728, which also lists 5 linked publications.

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 28 Apr 2021.

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