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Completed

NCT Number: NCT02409706

Micronutrients in Children in Critical Care With Cardiac Conditions

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.

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Key information

Conditions

Heart Defects, Congenital Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Diseases

Age range

Up to 5 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal Hospital for Sick Children

Glasgow, Glasgow City, G3 8SJ, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Micronutrient Status

    Time frame: Pre- and post- operative: 24-48 hours

    Micronutrient concentrations in plasma and erythrocytes

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

NHS Greater Glasgow and Clyde

Other

Collaborators

  • University of Glasgow

Registry information

Official study title

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

Acronym: MC5

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Apr 7, 2015
Registry last updated
Jun 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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