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

June 15, 2016 updated by: NHS Greater Glasgow and Clyde

Micronutrient Deficiencies in Children and Infants With Congenital Heart Diseases (CHD) Admitted for Cardiac Surgery: A Proof-of-concept Study

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Glasgow City
      • Glasgow, Glasgow City, United Kingdom, G3 8SJ
        • Royal Hospital for Sick Children

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Micronutrient Status
Time Frame: Pre- and post- operative: 24-48 hours
Micronutrient concentrations in plasma and erythrocytes
Pre- and post- operative: 24-48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative LOS
Time Frame: 1 year
Length of hospital stay
1 year
Postoperative Infectious complications
Time Frame: 1 year
Incidence of infections
1 year
Postoperative ventilator time
Time Frame: 1 year
Duration of ventilation
1 year
Postoperative LICU
Time Frame: 1 year
Length of stay in PICU
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NHS Greater Glasgow and Clyde

Collaborators

University of Glasgow

Investigators

  • Principal Investigator: Neil Spenceley, MBChB, Royal Hospital for Sick Children, Glasgow

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

March 27, 2015

First Submitted That Met QC Criteria

April 6, 2015

First Posted (Estimate)

April 7, 2015

Study Record Updates

Last Update Posted (Estimate)

June 16, 2016

Last Update Submitted That Met QC Criteria

June 15, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GN14KH356 (Other Identifier: NHS Greater Glasgow and Clyde)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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