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Micronutrients in Children in Critical Care With Cardiac Conditions (MC5)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02409706
Recruitment Status : Completed
First Posted : April 7, 2015
Last Update Posted : June 16, 2016
Sponsor:
Collaborator:
University of Glasgow
Information provided by (Responsible Party):
NHS Greater Glasgow and Clyde

Brief Summary:
This study aims to explore the frequency and types of micronutrient deficiencies in a sample of UK children with CHD using standard and novel markers in blood. The study will also explore whether micronutrient deficiencies increase the risk of complications after heart surgery. This study will identify any nutrient deficiencies that need monitoring in clinical practice.

Condition or disease
Heart Defects, Congenital

Detailed Description:

Congenital heart disease (CHD) is one of the most common birth defects in the UK. Children with CHD are at risk of underfeeding and undernutrition. This is due to both the increased nutritional requirements of the disease and sometimes clinical management, which often hinders delivery of optimal nutrition.There are as yet no studies assessing micronutrient body stores in children with CHD or whether micronutrient deficiencies predict poor clinical outcomes, such as post-operative complications, after major cardiac operations.

This study aims to explore the frequency, types and associations of micronutrient deficiencies in children with CHD using standard and novel markers in blood. The study will also explore whether micronutrient deficiencies increase the risk of complications after heart surgery. This study will identify any nutrient deficiencies that need monitoring in clinical practice.

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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Micronutrient Deficiencies in Children and Infants With Congenital Heart Diseases (CHD) Admitted for Cardiac Surgery: A Proof-of-concept Study
Study Start Date : August 2014
Actual Primary Completion Date : January 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Micronutrient Status [ Time Frame: Pre- and post- operative: 24-48 hours ]
    Micronutrient concentrations in plasma and erythrocytes


Secondary Outcome Measures :
  1. Postoperative LOS [ Time Frame: 1 year ]
    Length of hospital stay

  2. Postoperative Infectious complications [ Time Frame: 1 year ]
    Incidence of infections

  3. Postoperative ventilator time [ Time Frame: 1 year ]
    Duration of ventilation

  4. Postoperative LICU [ Time Frame: 1 year ]
    Length of stay in PICU


Biospecimen Retention:   Samples Without DNA
Whole blood Plasma Red blood cells


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children with congenital heart defects who are admitted for elective cardiac surgery at the Royal Hospital for Sick Children, Glasgow.
Criteria

Inclusion Criteria:

  • Infant or child admitted for elective congenital cardiac surgery at the Royal Hospital for Sick Children, Glasgow.
  • Aged less than 5 years old

Exclusion Criteria:

  • Infant or child admitted for emergency cardiac surgery
  • Infant or child whose carer with parental responsibility is unable to communicate in English

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): NCT02409706


Locations
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United Kingdom
Royal Hospital for Sick Children
Glasgow, Glasgow City, United Kingdom, G3 8SJ
Sponsors and Collaborators
NHS Greater Glasgow and Clyde
University of Glasgow
Investigators
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Principal Investigator: Neil Spenceley, MBChB Royal Hospital for Sick Children, Glasgow
Publications:
Bird J, Gentles E, Diamantidi K, Spenceley N, Gerasimidis K. Nutritional intake in a cardiac PICU improved following the introduction of enteral nutrition guidelines. Journal of American Dietetic Association 2013
Bird J, Gentles E, Diamantidi K, Alfheeaid H, MacLeod I, Ellis D, Spenceley N, Davidson M, Gerasimidis K. Micronutrient intake in a mixed speciality paediatric intensive care unit. World Congress of Paediatric Intensive Care 2011
Gentles E, Bird J, Davidson M, Spenceley N, Ellis D and Macleod I. The impact of fasting, fluid restriction and slow initiation and advancement of enteral feeds on daily energy intake in PICU. Paediatric Intenstive Care Society Annual Conference 2010

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Responsible Party: NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier: NCT02409706    
Other Study ID Numbers: GN14KH356
GN14KH356 ( Other Identifier: NHS Greater Glasgow and Clyde )
First Posted: April 7, 2015    Key Record Dates
Last Update Posted: June 16, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by NHS Greater Glasgow and Clyde:
Paediatric
Critical care
Micronutrients
Additional relevant MeSH terms:
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Heart Defects, Congenital
Congenital Abnormalities
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases