Evaluating the Alimentary and Respiratory Tracts in Health and Disease (EARTH) Research Program.
试验速览
- 阶段
- 不适用
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- 1A.ii.0 Intestinal Microbiome (Bacteria) - Shannon index
研究概览
简要总结
The investigators have established the "Evaluating the Alimentary and Respiratory Tracts in Health and disease" (EARTH) research program. It provides a structured approach to analysing gastrointestinal and respiratory microbiomes, along with diet and symptomatology, in children with a gastrointestinal and/or respiratory condition with recognised long-term morbidity (e.g. cystic fibrosis, obstructive sleep apnoea, or Hirschsprung's disease).
The EARTH program consists of a series of prospective, longitudinal, controlled, observational studies, with each individual study comparing children with a chronic gastrointestinal and/or respiratory condition to healthy controls (HC). It will be conducted in an Australian tertiary paediatric hospital (although the methodology is applicable to other settings). Children with a chronic gastrointestinal and/or respiratory condition will be compared to age and gender matched HC across a 12-month period. The following will be collected at baseline, 6 and 12 months: (i) a stool sample, (ii) an oropharyngeal swab or sputum sample, (iii) a semi-quantitative food frequency questionnaire, (iv) details of disease symptomatology, (v) health-related quality of life, and (vi) psychosocial factors. Data on the intestinal and respiratory microbiomes and diet will be compared between children with a condition and HC. Correlations between dietary intake (energy, macro- and micro-nutrients), intestinal and respiratory microbiomes within each group will be explored. Data on disease symptomatology, quality of life and psychosocial factors will also be compared between children with a condition and HC.
The investigators hypothesise that:
(i) Children with chronic gastrointestinal and/or respiratory conditions will have altered intestinal and respiratory microbiomes compared to healthy children, and (ii) Diet plays a key role in influencing the intestinal and respiratory microbiomes and this may impact on clinical outcomes, biomarkers of disease, and health-related quality of life.
详细描述
The objective of this research program is to evaluate and compare children with a chronic gastrointestinal and/or respiratory condition and age and gender matched HC. The primary objectives include analysing the intestinal and respiratory microbiomes (using an integrated "omics" approach) and dietary intake using validated, food frequency quetsionnaires. The secondary objectives include evaluating:
- Known inflammatory biomarkers.
- Symptomatology and health-related quality of life (HRQOL) using validated measures.
- Phenotypic and clinical information.
- Sociodemographic factors Additional secondary objectives include correlating within children with the same condition: (i) dietary intake with the intestinal microbiome; (ii) dietary intake with the respiratory microbiome; and (iii) the intestinal and respiratory microbiomes.
The investigators hypothesise that:
(i) Children with chronic gastrointestinal and/or respiratory conditions will have altered intestinal and respiratory microbiomes compared to healthy children, and (ii) Diet plays a key role in influencing the intestinal and respiratory microbiomes and this may impact on clinical outcomes, biomarkers of disease, and health-related quality of life.
To our knowledge, this program will enable the first series of studies comparing the intestinal and respiratory microbiomes and diet in children with chronic gastrointestinal and/or respiratory conditions. Initial results will be hypothesis-generating and used to direct future studies tailored to a specific focus or line of inquiry. Additionally, studies from this research program have potential for direct translation into clinical care as diet is a highly modifiable factor.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Are aged between 0 and 18 years;
- •Have been diagnosed with a chronic gastrointestinal and/or respiratory condition defined by consensus diagnostic criteria; or
- •Are free of any chronic health condition (healthy control group); and
- •Have a parent(s)/carer(s) who provides informed consent, or are at least 16 years old and provide informed consent.
排除标准
- •Children who have an unrelated coexisting chronic medical illness(es) associated with alterations in dietary intake or suspected alterations in the intestinal and/or respiratory microbiomes;
- •Inability to comply with study requirements;
- •Parent(s)/guardian(s) are unable to speak English or do not have a reading level age of at least 12 years.
结局指标
主要结局
1A.ii.0 Intestinal Microbiome (Bacteria) - Shannon index
时间窗: Baseline
Measurement of alpha diversity (assessed using 16S rRNA or metagenomic gene sequencing).
1A.ii.6 Intestinal Microbiome (Bacteria) - Shannon index
时间窗: Change from baseline at 6 months
Measurement of alpha diversity (assessed using 16S rRNA or metagenomic gene sequencing).
1A.i.0 Intestinal Microbiome (Bacteria) - Richness
时间窗: Baseline
Measurement of alpha diversity (assessed using 16S rRNA or metagenomic gene sequencing).
1A.i.6 Intestinal Microbiome (Bacteria) - Richness
时间窗: Change from baseline at 6 months
Measurement of alpha diversity (assessed using 16S rRNA or metagenomic gene sequencing).
1A.i.12 Intestinal Microbiome (Bacteria) - Richness
时间窗: Change from baseline at 12 months
Measurement of alpha diversity (assessed using 16S rRNA or metagenomic gene sequencing).
1A.iii.6 Intestinal Microbiome (Bacteria) - UNIFRAC distances
时间窗: 6 months
Measurement of beta diversity (assessed using 16S rRNA or metagenomic gene sequencing).
1A.iii.12 Intestinal Microbiome (Bacteria) - UNIFRAC distances
时间窗: 12 months
Measurement of beta diversity (assessed using 16S rRNA or metagenomic gene sequencing).
1A.iv.0 Intestinal Microbiome (Bacteria) - relative abundances of bacteria
时间窗: Baseline
ANCOM analysis (assessed using 16S rRNA or metagenomic gene sequencing).
1A.iv.6 Intestinal Microbiome (Bacteria) - relative abundances of bacteria
时间窗: Change from baseline at 6 months
ANCOM analysis (assessed using 16S rRNA or metagenomic gene sequencing).
1A.iv.12 Intestinal Microbiome (Bacteria) - relative abundances of bacteria
时间窗: Change from baseline at 12 months
ANCOM analysis (assessed using 16S rRNA or metagenomic gene sequencing).
1A.ii.12 Intestinal Microbiome (Bacteria) - Shannon index
时间窗: Change from baseline at 12 months
Measurement of alpha diversity (assessed using 16S rRNA or metagenomic gene sequencing).
1A.iii.0 Intestinal Microbiome (Bacteria) - UNIFRAC distances
时间窗: Baseline
Measurement of beta diversity (assessed using 16S rRNA or metagenomic gene sequencing).
1B.i.0 Intestinal Microbiome (Proteome) - normalised abundances of proteins
时间窗: Baseline
(assessed using LC-MS).
1B.i.6 Intestinal Microbiome (Proteome) - normalised abundances of proteins
时间窗: Change from baseline at 6 months
(assessed using LC-MS).
1B.i.12 Intestinal Microbiome (Proteome) - normalised abundances of proteins
时间窗: Change from baseline at 12 months
(assessed using LC-MS).
1C.i.0 Intestinal Microbiome (Metabolome) - normalised abundances of metabolites
时间窗: Baseline
(assessed using LC-MS).
1D.i.0 Intestinal Microbiome (Viruses) - Richness
时间窗: Baseline
Measurement of alpha diversity (assessed metagenomic sequencing).
1C.i.6 Intestinal Microbiome (Metabolome) - normalised abundances of metabolites
时间窗: Change from baseline at 6 months
(assessed using LC-MS).
1C.i.12 Intestinal Microbiome (Metabolome) - normalised abundances of metabolites
时间窗: Change from baseline at 12 months
(assessed using LC-MS).
1D.i.6 Intestinal Microbiome (Viruses) - Richness
时间窗: Change from baseline at 6 months
Measurement of alpha diversity (assessed metagenomic sequencing).
1D.i.12 Intestinal Microbiome (Viruses) - Richness
时间窗: Change from baseline at 12 months
Measurement of alpha diversity (assessed metagenomic sequencing).
1D.ii.6 Intestinal Microbiome (Viruses) - Shannon index
时间窗: Change from baseline at 6 months
Measurement of alpha diversity (assessed metagenomic sequencing).
1D.ii.12 Intestinal Microbiome (Viruses) - Shannon index
时间窗: Change from baseline at 12 months
Measurement of alpha diversity (assessed metagenomic sequencing).
1D.iii.0 Intestinal Microbiome (Viruses) - Bray-Curtis dissimilarity
时间窗: Baseline
Measurement of beta diversity (assessed metagenomic sequencing).
1D.ii.0 Intestinal Microbiome (Viruses) - Shannon index
时间窗: Baseline
Measurement of alpha diversity (assessed metagenomic sequencing).
1D.iii.12 Intestinal Microbiome (Viruses) - Bray-Curtis dissimilarity
时间窗: 12 months
Measurement of beta diversity (assessed metagenomic sequencing).
1D.iii.6 Intestinal Microbiome (Viruses) - Bray-Curtis dissimilarity
时间窗: 6 months
Measurement of beta diversity (assessed metagenomic sequencing).
1D.iv.12 Intestinal Microbiome (Viruses) - relative abundances of viruses.
时间窗: Change from baseline at 12 months
ANCOM analysis (assessed metagenomic sequencing).
2A.i.6 Respiratory Microbiome (Bacteria) - Richness
时间窗: Change from baseline at 6 months
Measurement of alpha diversity (assessed using 16S rRNA or metagenomic gene sequencing).
1D.iv.0 Intestinal Microbiome (Viruses) - relative abundances of viruses.
时间窗: Baseline
ANCOM analysis (assessed metagenomic sequencing).
1D.iv.6 Intestinal Microbiome (Viruses) - relative abundances of viruses.
时间窗: Change from baseline at 6 months
ANCOM analysis (assessed metagenomic sequencing).
2A.i.0 Respiratory Microbiome (Bacteria) - Richness
时间窗: Baseline
Measurement of alpha diversity (assessed using 16S rRNA or metagenomic gene sequencing).
2A.i.12 Respiratory Microbiome (Bacteria) - Richness
时间窗: Change from baseline at 12 months
Measurement of alpha diversity (assessed using 16S rRNA or metagenomic gene sequencing).
2A.ii.0 Respiratory Microbiome (Bacteria) - Shannon index
时间窗: Baseline
Measurement of alpha diversity (assessed using 16S rRNA or metagenomic gene sequencing).
2A.ii.6 Respiratory Microbiome (Bacteria) - Shannon index
时间窗: Change from baseline at 6 months
Measurement of alpha diversity (assessed using 16S rRNA or metagenomic gene sequencing).
2A.ii.12 Respiratory Microbiome (Bacteria) - Shannon index
时间窗: Change from baseline at 12 months
Measurement of alpha diversity (assessed using 16S rRNA or metagenomic gene sequencing).
2A.iii.12 Respiratory Microbiome (Bacteria) - UNIFRAC distances
时间窗: Change from baseline at 12 months
Measurement of beta diversity (assessed using 16S rRNA or metagenomic gene sequencing).
2A.iii.0 Respiratory Microbiome (Bacteria) - UNIFRAC distances
时间窗: Baseline
Measurement of beta diversity (assessed using 16S rRNA or metagenomic gene sequencing).
2A.iii.6 Respiratory Microbiome (Bacteria) - UNIFRAC distances
时间窗: Change from baseline at 6 months
Measurement of beta diversity (assessed using 16S rRNA or metagenomic gene sequencing).
2A.iv.0 Respiratory Microbiome (Bacteria) - relative abundances of bacteria
时间窗: Baseline
ANCOM analysis (assessed using 16S rRNA or metagenomic gene sequencing).
2B.i.0 Respiratory Microbiome (Proteome) - normalised abundances of proteins
时间窗: Baseline
(assessed using LC-MS).
2A.iv.6 Respiratory Microbiome (Bacteria) - relative abundances of bacteria
时间窗: Change from baseline at 6 months
ANCOM analysis (assessed using 16S rRNA or metagenomic gene sequencing).
2C.i.0 Respiratory Microbiome (Metabolome) - normalised abundances of metabolites
时间窗: Baseline
(assessed using LC-MS).
2D.i.12 Respiratory Microbiome (Viruses) - Richness
时间窗: Change from baseline at 12 months
Measurement of alpha diversity (assessed metagenomic sequencing).
2A.iv.12 Respiratory Microbiome (Bacteria) - relative abundances of bacteria
时间窗: Change from baseline at 12 months
ANCOM analysis (assessed using 16S rRNA or metagenomic gene sequencing).
2B.i.6 Respiratory Microbiome (Proteome) - normalised abundances of proteins
时间窗: Change from baseline at 6 months
(assessed using LC-MS).
2B.i.12 Respiratory Microbiome (Proteome) - normalised abundances of proteins
时间窗: Change from baseline at 12 months
(assessed using LC-MS).
2C.i.6 Respiratory Microbiome (Metabolome) - normalised abundances of metabolites
时间窗: Change from baseline at 6 months
(assessed using LC-MS).
2C.i.12 Respiratory Microbiome (Metabolome) - normalised abundances of metabolites
时间窗: Change from baseline at 12 months
(assessed using LC-MS).
2D.i.0 Respiratory Microbiome (Viruses) - Richness
时间窗: Baseline
Measurement of alpha diversity (assessed metagenomic sequencing).
2D.i.6 Respiratory Microbiome (Viruses) - Richness
时间窗: Change from baseline at 6 months
Measurement of alpha diversity (assessed metagenomic sequencing).
2D.ii.0 Respiratory Microbiome (Viruses) - Shannon index
时间窗: Baseline
Measurement of alpha diversity (assessed metagenomic sequencing).
2D.ii.6 Respiratory Microbiome (Viruses) - Shannon index
时间窗: Change from baseline at 6 months
Measurement of alpha diversity (assessed metagenomic sequencing).
2D.ii.12 Respiratory Microbiome (Viruses) - Shannon index
时间窗: Change from baseline at 12 months
Measurement of alpha diversity (assessed metagenomic sequencing).
2D.iii.0 Respiratory Microbiome (Viruses) - Bray-Curtis dissimilarity
时间窗: Baseline
Measurement of beta diversity (assessed metagenomic sequencing).
2D.iv.6 Respiratory Microbiome (Viruses) - relative abundances of viruses
时间窗: Change from baseline at 6 months
ANCOM analysis (assessed metagenomic sequencing).
2D.iii.6 Respiratory Microbiome (Viruses) - Bray-Curtis dissimilarity
时间窗: 6 months
Measurement of beta diversity (assessed metagenomic sequencing).
2D.iii.12 Respiratory Microbiome (Viruses) - Bray-Curtis dissimilarity
时间窗: 12 months
Measurement of beta diversity (assessed metagenomic sequencing).
2D.iv.0 Respiratory Microbiome (Viruses) - relative abundances of viruses
时间窗: Baseline
ANCOM analysis (assessed metagenomic sequencing).
3A.i.6 Diet - total energy intake
时间窗: Change from baseline at 6 months
Kilojoules (assessed using a 24-hour recall or ACAES).
3A.i.12 Diet - total energy intake
时间窗: Change from baseline at 12 months
Kilojoules (assessed using a 24-hour recall or ACAES).
3B.i.6 Diet - percentage energy from core foods
时间窗: Change from baseline at 6 months
(assessed using a 24-hour recall or ACAES).
2D.iv.12 Respiratory Microbiome (Viruses) - relative abundances of viruses
时间窗: Change from baseline at 12 months
ANCOM analysis (assessed metagenomic sequencing).
3A.i.0 Diet - total energy intake
时间窗: Baseline
Kilojoules (assessed using a 24-hour recall or ACAES).
3B.i.0 Diet - percentage energy from core foods
时间窗: Baseline
(assessed using a 24-hour recall or ACAES).
3B.i.12 Diet - percentage energy from core foods
时间窗: Change from baseline at 12 months
(assessed using a 24-hour recall or ACAES).
3C.i.0 Diet - total macronutrients intake
时间窗: Baseline
Grams (assessed using a 24-hour recall or ACAES).
3C.i.6 Diet - total macronutrients intake
时间窗: Change from baseline at 6 months
Grams (assessed using a 24-hour recall or ACAES).
3C.ii.6 Diet - macronutrients proportion of total energy intake
时间窗: Change from baseline at 6 months
Percentage (assessed using a 24-hour recall or ACAES).
3C.i.12 Diet - total macronutrients intake
时间窗: Change from baseline at 12 months
Grams (assessed using a 24-hour recall or ACAES).
3C.ii.0 Diet - macronutrients proportion of total energy intake
时间窗: Baseline
Percentage (assessed using a 24-hour recall or ACAES).
3C.ii.12 Diet - macronutrients proportion of total energy intake
时间窗: Change from baseline at 12 months
Percentage (assessed using a 24-hour recall or ACAES).
3D.i.0 Diet - total micronutrients intake
时间窗: Baseline
Milligrams (assessed using a 24-hour recall or ACAES).
3D.i.6 Diet - total micronutrients intake
时间窗: Change from baseline at 6 months
Milligrams (assessed using a 24-hour recall or ACAES).
3D.i.12 Diet - total micronutrients intake
时间窗: Change from baseline at 12 months
Milligrams (assessed using a 24-hour recall or ACAES).
3D.ii.0 Diet - micronutrients proportion of total energy intake
时间窗: Baseline
Percentage (assessed using a 24-hour recall or ACAES).
3E.i.12 Diet - diet quality score
时间窗: Change from baseline at 12 months
Australia recommended food score. Maximum possible score of 73, higher is better (assessed using the ACAES only).
3D.ii.6 Diet - micronutrients proportion of total energy intake
时间窗: Change from baseline at 6 months
Percentage (assessed using a 24-hour recall or ACAES).
3D.ii.12 Diet - micronutrients proportion of total energy intake
时间窗: Change from baseline at 12 months
Percentage (assessed using a 24-hour recall or ACAES).
3E.i.6 Diet - diet quality score
时间窗: Change from baseline at 6 months
Australia recommended food score. Maximum possible score of 73, higher is better (assessed using the ACAES only).
3E.i.0 Diet - diet quality score
时间窗: Baseline
Australia recommended food score. Maximum possible score of 73, higher is better (assessed using the ACAES only).
次要结局
- 4A.iii.6 Faecal biomarkers - C-reactive protein(Change from baseline at 6 months)
- 4A.i.12 Faecal biomarkers - calprotectin(Change from baseline at 12 months)
- 4A.ii.6 Faecal biomarkers - M2 pyruvate kinase(Change from baseline at 6 months)
- 4A.ii.12 Faecal biomarkers - M2 pyruvate kinase(Change from baseline at 12 months)
- 4A.iii.12 Faecal biomarkers - C-reactive protein(Change from baseline at 12 months)
- 4A.i.0 Faecal biomarkers - calprotectin(Baseline)
- 4A.i.6 Faecal biomarkers - calprotectin(Change from baseline at 6 months)
- 4A.ii.0 Faecal biomarkers - M2 pyruvate kinase(Baseline)
- 4A.iii.0 Faecal biomarkers - C-reactive protein(Baseline)
- 4A.iv.6 Faecal biomarkers - Interleukins(Change from baseline at 6 months)
- 4A.iv.12 Faecal biomarkers - Interleukins(Change from baseline at 12 months)
- 4B.i.6 Respiratory biomarkers - calprotectin(Change from baseline at 6 months)
- 4A.iv.0 Faecal biomarkers - Interleukins(Baseline)
- 4B.i.0 Respiratory biomarkers - calprotectin(Baseline)
- 4B.i.12 Respiratory biomarkers - calprotectin(Change from baseline at 12 months)
- 4B.ii.6 Respiratory biomarkers - C-reactive protein(Change from baseline at 6 months)
- 4B.ii.0 Respiratory biomarkers - C-reactive protein(Baseline)
- 4B.iii.6 Respiratory biomarkers - Interleukins(Change from baseline at 6 months)
- 4B.iii.12 Respiratory biomarkers - Interleukins(Change from baseline at 12 months)
- 5A.iii.12 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 5-7 years)(Change from baseline at 12 months)
- 5A.iv.0 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 8-12 years)(Baseline)
- 5A.v.12 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 13-18 years)(Change from baseline at 12 months)
- 5B.i.0 Symptomatology & HRQOL - Rome IV Parent-Report Form for Infants and Toddlers (ages 0-3)(Baseline)
- 4B.ii.12 Respiratory biomarkers - C-reactive protein(Change from baseline at 12 months)
- 4B.iii.0 Respiratory biomarkers - Interleukins(Baseline)
- 5A.i.0 Symptomatology & HRQOL - PedsQL Infant Scales (ages 1-12 and 13-24 months)(Baseline)
- 5A.i.6 Symptomatology & HRQOL - PedsQL Infant Scales (ages 1-12 and 13-24 months)(Change from baseline at 6 months)
- 5A.iii.0 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 5-7 years)(Baseline)
- 5A.i.12 Symptomatology & HRQOL - PedsQL Infant Scales (ages 1-12 and 13-24 months)(Change from baseline at 12 months)
- 5A.ii.0 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 2-4 years)(Baseline)
- 5A.iii.6 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 5-7 years)(Change from baseline at 6 months)
- 5A.ii.6 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 2-4 years)(Change from baseline at 6 months)
- 5A.ii.12 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 2-4 years)(Change from baseline at 12 months)
- 5A.iv.6 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 8-12 years)(Change from baseline at 6 months)
- 5A.iv.12 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 8-12 years)(Change from baseline at 12 months)
- 5A.v.0 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 13-18 years)(Baseline)
- 5A.v.6 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 13-18 years)(Change from baseline at 6 months)
- 5B.i.6 Symptomatology & HRQOL - Rome IV Parent-Report Form for Infants and Toddlers (ages 0-3)(6 months)
- 5B.i.12 Symptomatology & HRQOL - Rome IV Parent-Report Form for Infants and Toddlers (ages 0-3)(12 months)
- 5B.iii.0 Symptomatology & HRQOL - Rome IV Self-Report Form for Children and Adolescents (10 years of age and older)(Baseline)
- 5B.iii.6 Symptomatology & HRQOL - Rome IV Self-Report Form for Children and Adolescents (10 years of age and older)(6 months)
- 5B.iii.12 Symptomatology & HRQOL - Rome IV Self-Report Form for Children and Adolescents (10 years of age and older)(12 months)
- 5B.ii.0 Symptomatology & HRQOL - Rome IV Parent-Report Form for Children and Adolescents (4 years of age and older)(Baseline)
- 5B.ii.6 Symptomatology & HRQOL - Rome IV Parent-Report Form for Children and Adolescents (4 years of age and older)(6 months)
- 5B.ii.12 Symptomatology & HRQOL - Rome IV Parent-Report Form for Children and Adolescents (4 years of age and older)(12 months)
- 5C.ii.6 Symptomatology & HRQOL - Spence Children's Anxiety Scale (Parent report for 5 years and older)(Change from baseline at 6 months)
- 5C.i.0 Symptomatology & HRQOL - Spence Children's Anxiety Scale; Preschool Anxiety Scale (Parent report for ages 0 to 4)(Baseline)
- 5C.i.12 Symptomatology & HRQOL - Spence Children's Anxiety Scale; Preschool Anxiety Scale (Parent report for ages 0 to 4)(Change from baseline at 12 months)
- 5D.i.6 Symptomatology & HRQOL - Mood and Feelings Questionnaire (Short Version) (Parent Report on Child, ages 6-18 years).(Change from baseline at 6 months)
- 5D.i.12 Symptomatology & HRQOL - Mood and Feelings Questionnaire (Short Version) (Parent Report on Child, ages 6-18 years).(Change from baseline at 12 months)
- 5D.ii.0 Symptomatology & HRQOL - Mood and Feelings Questionnaire (Short Version) (Child Self Report, ages 6-18 years).(Baseline)
- 5D.ii.6 Symptomatology & HRQOL - Mood and Feelings Questionnaire (Short Version) (Child Self Report, ages 6-18 years).(Change from baseline at 6 months)
- 6A.i.0 Phenotypic & Clinical Information - Weight (ages 0 to 20 years)(Baseline)
- 6A.i.6 Phenotypic & Clinical Information - Weight (ages 0 to 20 years)(Change from baseline at 6 months)
- 5C.i.6 Symptomatology & HRQOL - Spence Children's Anxiety Scale; Preschool Anxiety Scale (Parent report for ages 0 to 4)(Change from baseline at 6 months)
- 5C.ii.12 Symptomatology & HRQOL - Spence Children's Anxiety Scale (Parent report for 5 years and older)(Change from baseline at 12 months)
- 5C.iii.0 Symptomatology & HRQOL - Spence Children's Anxiety Scale (8 years and older)(Baseline)
- 5C.ii.0 Symptomatology & HRQOL - Spence Children's Anxiety Scale (Parent report for 5 years and older)(Baseline)
- 5C.iii.6 Symptomatology & HRQOL - Spence Children's Anxiety Scale (8 years and older)(Change from baseline at 6 months)
- 5C.iii.12 Symptomatology & HRQOL - Spence Children's Anxiety Scale (8 years and older)(Change from baseline at 12 months)
- 5D.i.0 Symptomatology & HRQOL - Mood and Feelings Questionnaire (Short Version) (Parent Report on Child, ages 6-18 years).(Baseline)
- 5D.ii.12 Symptomatology & HRQOL - Mood and Feelings Questionnaire (Short Version) (Child Self Report, ages 6-18 years).(Change from baseline at 12 months)
- 6A.i.12 Phenotypic & Clinical Information - Weight (ages 0 to 20 years)(Change from baseline at 12 months)
- 6A.ii.0 Phenotypic & Clinical Information - Length (ages 0 to 2 years)(Baseline)
- 6A.ii.6 Phenotypic & Clinical Information - Length (ages 0 to 2 years)(Change from baseline at 6 months)
- 6A.ii.12 Phenotypic & Clinical Information - Length (ages 0 to 2 years)(Change from baseline at 12 months)
- 6A.iii.0 Phenotypic & Clinical Information - Height (ages 2 to 20 years)(Baseline)
- 6A.iii.6 Phenotypic & Clinical Information - Height (ages 2 to 20 years)(Change from baseline at 6 months)
- 6A.iii.12 Phenotypic & Clinical Information - Height (ages 2 to 20 years)(Change from baseline at 12 months)
- 6A.iv.0 Phenotypic & Clinical Information - Weight-for-length (ages 0 to 2 years)(Baseline)
- 6A.iv.6 Phenotypic & Clinical Information - Weight-for-length (ages 0 to 2 years)(Change from baseline at 6 months)
- 6A.iv.12 Phenotypic & Clinical Information - Weight-for-length (ages 0 to 2 years)(Change from baseline at 12 months)
- 6A.v.12 Phenotypic & Clinical Information - Body mass index (ages 2 to 20 years)(Change from baseline at 12 months)
- 6B.iii.12 Phenotypic & Clinical Information - Number of emergency department presentations(12 months)
- 6A.v.0 Phenotypic & Clinical Information - Body mass index (ages 2 to 20 years)(Baseline)
- 6A.v.6 Phenotypic & Clinical Information - Body mass index (ages 2 to 20 years)(Change from baseline at 6 months)
- 6B.i.6 Phenotypic & Clinical Information - Number of hospitalisations(6 months)
- 6B.i.12 Phenotypic & Clinical Information - Number of hospitalisations(12 months)
- 6B.ii.6 Phenotypic & Clinical Information - Length of hospitalisations(6 months)
- 6B.iii.6 Phenotypic & Clinical Information - Number of emergency department presentations(6 months)
- 6B.ii.12 Phenotypic & Clinical Information - Length of hospitalisations(12 months)
研究者
Dr Michael Coffey
Principal Investigator
The University of New South Wales