Clinical trial NCT04071314: Evaluating the Alimentary and Respiratory Tracts in Health and Disease (EARTH) Research Program.
Official title: Evaluating the Alimentary and Respiratory Tracts in Health and Disease (EARTH) Research Program.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cystic Fibrosis
Hirschprung's Disease
Obstructive Sleep Apnea
Healthy
Keywords: Microbiota
Gastrointestinal Microbiome
Diet
Signs and Symptoms
Quality of Life
Anxiety
Depression
Lead sponsor: The University of New South Wales
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 72
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Studies will be carried out at a single centre; the Sydney Children's Hospital (SCH) in Randwick, Australia. SCH is a tertiary paediatric hospital. Participants with chronic gastrointestinal and/or respiratory conditions will be approached at their routine clinic appointments in the outpatient department. Flyers will be placed in the hospital for recruitment of HC.

Brief summary: 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.

Detailed description: 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:

1. Known inflammatory biomarkers.
2. Symptomatology and health-related quality of life (HRQOL) using validated measures.
3. Phenotypic and clinical information.
4. 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.

Study design. The EARTH program provides a framework for a series of prospective, longitudinal, controlled, observational studies, with each individual study comparing children with a chronic gastrointestinal and/or respiratory condition to HC. A single healthy control group will be used for comparison against all conditions. The standardised methodological approach will also allow for comparisons between different health conditions.

Procedures.

Each participant will be assessed on three occasions over a 12-month period; at study entry, 6- and 12-month follow-up. At each time-point, the following will be collected:

* A stool sample;
* An oropharyngeal swab or sputum sample (a sputum sample will be obtained in children able to expectorate and an oropharyngeal swab will be collected in children unable to expectorate);
* Dietary intake measured using the Australian Child and Adolescent Eating Survey (ACAES) (2 to 18 years) or 24-hour food recall (0 up to 2 years);
* A secure, password-protected online survey comprising:

  i. PedsQL Infant Scales (0-2yr) \& Gastrointestinal Symptoms Module (2-18yr),41-43 tailored to age; ii. Rome IV Questionnaire (0 to 18 years); iii. Spence Children's Anxiety Scale (3 to 18 years); iv. Short Mood and Feelings Questionnaires (6 to 18 years); v. Clinical and biochemical results obtained through routine care and hospitalisations (if available); vi. Sociodemographic factors (baseline survey only);
* Anthropometrics: height, weight and BMI z-scores.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: 1A.i.0 Intestinal Microbiome (Bacteria) - Richness
timeFrame: Baseline
measure: 1A.i.6 Intestinal Microbiome (Bacteria) - Richness
timeFrame: Change from baseline at 6 months
measure: 1A.i.12 Intestinal Microbiome (Bacteria) - Richness
timeFrame: Change from baseline at 12 months
measure: 1A.ii.0 Intestinal Microbiome (Bacteria) - Shannon index
timeFrame: Baseline
measure: 1A.ii.6 Intestinal Microbiome (Bacteria) - Shannon index
timeFrame: Change from baseline at 6 months
measure: 1A.ii.12 Intestinal Microbiome (Bacteria) - Shannon index
timeFrame: Change from baseline at 12 months
measure: 1A.iii.0 Intestinal Microbiome (Bacteria) - UNIFRAC distances
timeFrame: Baseline
measure: 1A.iii.6 Intestinal Microbiome (Bacteria) - UNIFRAC distances
timeFrame: 6 months
measure: 1A.iii.12 Intestinal Microbiome (Bacteria) - UNIFRAC distances
timeFrame: 12 months
measure: 1A.iv.0 Intestinal Microbiome (Bacteria) - relative abundances of bacteria
timeFrame: Baseline
measure: 1A.iv.6 Intestinal Microbiome (Bacteria) - relative abundances of bacteria
timeFrame: Change from baseline at 6 months
measure: 1A.iv.12 Intestinal Microbiome (Bacteria) - relative abundances of bacteria
timeFrame: Change from baseline at 12 months
measure: 1B.i.0 Intestinal Microbiome (Proteome) - normalised abundances of proteins
timeFrame: Baseline
measure: 1B.i.6 Intestinal Microbiome (Proteome) - normalised abundances of proteins
timeFrame: Change from baseline at 6 months
measure: 1B.i.12 Intestinal Microbiome (Proteome) - normalised abundances of proteins
timeFrame: Change from baseline at 12 months
measure: 1C.i.0 Intestinal Microbiome (Metabolome) - normalised abundances of metabolites
timeFrame: Baseline
measure: 1C.i.6 Intestinal Microbiome (Metabolome) - normalised abundances of metabolites
timeFrame: Change from baseline at 6 months
measure: 1C.i.12 Intestinal Microbiome (Metabolome) - normalised abundances of metabolites
timeFrame: Change from baseline at 12 months
measure: 1D.i.0 Intestinal Microbiome (Viruses) - Richness
timeFrame: Baseline
measure: 1D.i.6 Intestinal Microbiome (Viruses) - Richness
timeFrame: Change from baseline at 6 months
measure: 1D.i.12 Intestinal Microbiome (Viruses) - Richness
timeFrame: Change from baseline at 12 months
measure: 1D.ii.0 Intestinal Microbiome (Viruses) - Shannon index
timeFrame: Baseline
measure: 1D.ii.6 Intestinal Microbiome (Viruses) - Shannon index
timeFrame: Change from baseline at 6 months
measure: 1D.ii.12 Intestinal Microbiome (Viruses) - Shannon index
timeFrame: Change from baseline at 12 months
measure: 1D.iii.0 Intestinal Microbiome (Viruses) - Bray-Curtis dissimilarity
timeFrame: Baseline
measure: 1D.iii.6 Intestinal Microbiome (Viruses) - Bray-Curtis dissimilarity
timeFrame: 6 months
measure: 1D.iii.12 Intestinal Microbiome (Viruses) - Bray-Curtis dissimilarity
timeFrame: 12 months
measure: 1D.iv.0 Intestinal Microbiome (Viruses) - relative abundances of viruses.
timeFrame: Baseline
measure: 1D.iv.6 Intestinal Microbiome (Viruses) - relative abundances of viruses.
timeFrame: Change from baseline at 6 months
measure: 1D.iv.12 Intestinal Microbiome (Viruses) - relative abundances of viruses.
timeFrame: Change from baseline at 12 months
measure: 2A.i.0 Respiratory Microbiome (Bacteria) - Richness
timeFrame: Baseline
measure: 2A.i.6 Respiratory Microbiome (Bacteria) - Richness
timeFrame: Change from baseline at 6 months
measure: 2A.i.12 Respiratory Microbiome (Bacteria) - Richness
timeFrame: Change from baseline at 12 months
measure: 2A.ii.0 Respiratory Microbiome (Bacteria) - Shannon index
timeFrame: Baseline
measure: 2A.ii.6 Respiratory Microbiome (Bacteria) - Shannon index
timeFrame: Change from baseline at 6 months
measure: 2A.ii.12 Respiratory Microbiome (Bacteria) - Shannon index
timeFrame: Change from baseline at 12 months
measure: 2A.iii.0 Respiratory Microbiome (Bacteria) - UNIFRAC distances
timeFrame: Baseline
measure: 2A.iii.6 Respiratory Microbiome (Bacteria) - UNIFRAC distances
timeFrame: Change from baseline at 6 months
measure: 2A.iii.12 Respiratory Microbiome (Bacteria) - UNIFRAC distances
timeFrame: Change from baseline at 12 months
measure: 2A.iv.0 Respiratory Microbiome (Bacteria) - relative abundances of bacteria
timeFrame: Baseline
measure: 2A.iv.6 Respiratory Microbiome (Bacteria) - relative abundances of bacteria
timeFrame: Change from baseline at 6 months
measure: 2A.iv.12 Respiratory Microbiome (Bacteria) - relative abundances of bacteria
timeFrame: Change from baseline at 12 months
measure: 2B.i.0 Respiratory Microbiome (Proteome) - normalised abundances of proteins
timeFrame: Baseline
measure: 2B.i.6 Respiratory Microbiome (Proteome) - normalised abundances of proteins
timeFrame: Change from baseline at 6 months
measure: 2B.i.12 Respiratory Microbiome (Proteome) - normalised abundances of proteins
timeFrame: Change from baseline at 12 months
measure: 2C.i.0 Respiratory Microbiome (Metabolome) - normalised abundances of metabolites
timeFrame: Baseline
measure: 2C.i.6 Respiratory Microbiome (Metabolome) - normalised abundances of metabolites
timeFrame: Change from baseline at 6 months
measure: 2C.i.12 Respiratory Microbiome (Metabolome) - normalised abundances of metabolites
timeFrame: Change from baseline at 12 months
measure: 2D.i.0 Respiratory Microbiome (Viruses) - Richness
timeFrame: Baseline
measure: 2D.i.6 Respiratory Microbiome (Viruses) - Richness
timeFrame: Change from baseline at 6 months
measure: 2D.i.12 Respiratory Microbiome (Viruses) - Richness
timeFrame: Change from baseline at 12 months
measure: 2D.ii.0 Respiratory Microbiome (Viruses) - Shannon index
timeFrame: Baseline
measure: 2D.ii.6 Respiratory Microbiome (Viruses) - Shannon index
timeFrame: Change from baseline at 6 months
measure: 2D.ii.12 Respiratory Microbiome (Viruses) - Shannon index
timeFrame: Change from baseline at 12 months
measure: 2D.iii.0 Respiratory Microbiome (Viruses) - Bray-Curtis dissimilarity
timeFrame: Baseline
measure: 2D.iii.6 Respiratory Microbiome (Viruses) - Bray-Curtis dissimilarity
timeFrame: 6 months
measure: 2D.iii.12 Respiratory Microbiome (Viruses) - Bray-Curtis dissimilarity
timeFrame: 12 months
measure: 2D.iv.0 Respiratory Microbiome (Viruses) - relative abundances of viruses
timeFrame: Baseline
measure: 2D.iv.6 Respiratory Microbiome (Viruses) - relative abundances of viruses
timeFrame: Change from baseline at 6 months
measure: 2D.iv.12 Respiratory Microbiome (Viruses) - relative abundances of viruses
timeFrame: Change from baseline at 12 months
measure: 3A.i.0 Diet - total energy intake
timeFrame: Baseline
measure: 3A.i.6 Diet - total energy intake
timeFrame: Change from baseline at 6 months
measure: 3A.i.12 Diet - total energy intake
timeFrame: Change from baseline at 12 months
measure: 3B.i.0 Diet - percentage energy from core foods
timeFrame: Baseline
measure: 3B.i.6 Diet - percentage energy from core foods
timeFrame: Change from baseline at 6 months
measure: 3B.i.12 Diet - percentage energy from core foods
timeFrame: Change from baseline at 12 months
measure: 3C.i.0 Diet - total macronutrients intake
timeFrame: Baseline
measure: 3C.i.6 Diet - total macronutrients intake
timeFrame: Change from baseline at 6 months
measure: 3C.i.12 Diet - total macronutrients intake
timeFrame: Change from baseline at 12 months
measure: 3C.ii.0 Diet - macronutrients proportion of total energy intake
timeFrame: Baseline
measure: 3C.ii.6 Diet - macronutrients proportion of total energy intake
timeFrame: Change from baseline at 6 months
measure: 3C.ii.12 Diet - macronutrients proportion of total energy intake
timeFrame: Change from baseline at 12 months
measure: 3D.i.0 Diet - total micronutrients intake
timeFrame: Baseline
measure: 3D.i.6 Diet - total micronutrients intake
timeFrame: Change from baseline at 6 months
measure: 3D.i.12 Diet - total micronutrients intake
timeFrame: Change from baseline at 12 months
measure: 3D.ii.0 Diet - micronutrients proportion of total energy intake
timeFrame: Baseline
measure: 3D.ii.6 Diet - micronutrients proportion of total energy intake
timeFrame: Change from baseline at 6 months
measure: 3D.ii.12 Diet - micronutrients proportion of total energy intake
timeFrame: Change from baseline at 12 months
measure: 3E.i.0 Diet - diet quality score
timeFrame: Baseline
measure: 3E.i.6 Diet - diet quality score
timeFrame: Change from baseline at 6 months
measure: 3E.i.12 Diet - diet quality score
timeFrame: Change from baseline at 12 months
Secondary outcomes:
measure: 4A.i.0 Faecal biomarkers - calprotectin
timeFrame: Baseline
measure: 4A.i.6 Faecal biomarkers - calprotectin
timeFrame: Change from baseline at 6 months
measure: 4A.i.12 Faecal biomarkers - calprotectin
timeFrame: Change from baseline at 12 months
measure: 4A.ii.0 Faecal biomarkers - M2 pyruvate kinase
timeFrame: Baseline
measure: 4A.ii.6 Faecal biomarkers - M2 pyruvate kinase
timeFrame: Change from baseline at 6 months
measure: 4A.ii.12 Faecal biomarkers - M2 pyruvate kinase
timeFrame: Change from baseline at 12 months
measure: 4A.iii.0 Faecal biomarkers - C-reactive protein
timeFrame: Baseline
measure: 4A.iii.6 Faecal biomarkers - C-reactive protein
timeFrame: Change from baseline at 6 months
measure: 4A.iii.12 Faecal biomarkers - C-reactive protein
timeFrame: Change from baseline at 12 months
measure: 4A.iv.0 Faecal biomarkers - Interleukins
timeFrame: Baseline
measure: 4A.iv.6 Faecal biomarkers - Interleukins
timeFrame: Change from baseline at 6 months
measure: 4A.iv.12 Faecal biomarkers - Interleukins
timeFrame: Change from baseline at 12 months
measure: 4B.i.0 Respiratory biomarkers - calprotectin
timeFrame: Baseline
measure: 4B.i.6 Respiratory biomarkers - calprotectin
timeFrame: Change from baseline at 6 months
measure: 4B.i.12 Respiratory biomarkers - calprotectin
timeFrame: Change from baseline at 12 months
measure: 4B.ii.0 Respiratory biomarkers - C-reactive protein
timeFrame: Baseline
measure: 4B.ii.6 Respiratory biomarkers - C-reactive protein
timeFrame: Change from baseline at 6 months
measure: 4B.ii.12 Respiratory biomarkers - C-reactive protein
timeFrame: Change from baseline at 12 months
measure: 4B.iii.0 Respiratory biomarkers - Interleukins
timeFrame: Baseline
measure: 4B.iii.6 Respiratory biomarkers - Interleukins
timeFrame: Change from baseline at 6 months
measure: 4B.iii.12 Respiratory biomarkers - Interleukins
timeFrame: Change from baseline at 12 months
measure: 5A.i.0 Symptomatology & HRQOL - PedsQL Infant Scales (ages 1-12 and 13-24 months)
timeFrame: Baseline
measure: 5A.i.6 Symptomatology & HRQOL - PedsQL Infant Scales (ages 1-12 and 13-24 months)
timeFrame: Change from baseline at 6 months
measure: 5A.i.12 Symptomatology & HRQOL - PedsQL Infant Scales (ages 1-12 and 13-24 months)
timeFrame: Change from baseline at 12 months
measure: 5A.ii.0 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 2-4 years)
timeFrame: Baseline
measure: 5A.ii.6 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 2-4 years)
timeFrame: Change from baseline at 6 months
measure: 5A.ii.12 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 2-4 years)
timeFrame: Change from baseline at 12 months
measure: 5A.iii.0 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 5-7 years)
timeFrame: Baseline
measure: 5A.iii.6 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 5-7 years)
timeFrame: Change from baseline at 6 months
measure: 5A.iii.12 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 5-7 years)
timeFrame: Change from baseline at 12 months
measure: 5A.iv.0 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 8-12 years)
timeFrame: Baseline
measure: 5A.iv.6 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 8-12 years)
timeFrame: Change from baseline at 6 months
measure: 5A.iv.12 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 8-12 years)
timeFrame: Change from baseline at 12 months
measure: 5A.v.0 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 13-18 years)
timeFrame: Baseline
measure: 5A.v.6 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 13-18 years)
timeFrame: Change from baseline at 6 months
measure: 5A.v.12 Symptomatology & HRQOL - PedsQL Gastrointestinal Symptoms Module (ages 13-18 years)
timeFrame: Change from baseline at 12 months
measure: 5B.i.0 Symptomatology & HRQOL - Rome IV Parent-Report Form for Infants and Toddlers (ages 0-3)
timeFrame: Baseline
measure: 5B.i.6 Symptomatology & HRQOL - Rome IV Parent-Report Form for Infants and Toddlers (ages 0-3)
timeFrame: 6 months
measure: 5B.i.12 Symptomatology & HRQOL - Rome IV Parent-Report Form for Infants and Toddlers (ages 0-3)
timeFrame: 12 months
measure: 5B.ii.0 Symptomatology & HRQOL - Rome IV Parent-Report Form for Children and Adolescents (4 years of age and older)
timeFrame: Baseline
measure: 5B.ii.6 Symptomatology & HRQOL - Rome IV Parent-Report Form for Children and Adolescents (4 years of age and older)
timeFrame: 6 months
measure: 5B.ii.12 Symptomatology & HRQOL - Rome IV Parent-Report Form for Children and Adolescents (4 years of age and older)
timeFrame: 12 months
measure: 5B.iii.0 Symptomatology & HRQOL - Rome IV Self-Report Form for Children and Adolescents (10 years of age and older)
timeFrame: Baseline
measure: 5B.iii.6 Symptomatology & HRQOL - Rome IV Self-Report Form for Children and Adolescents (10 years of age and older)
timeFrame: 6 months
measure: 5B.iii.12 Symptomatology & HRQOL - Rome IV Self-Report Form for Children and Adolescents (10 years of age and older)
timeFrame: 12 months
measure: 5C.i.0 Symptomatology & HRQOL - Spence Children's Anxiety Scale; Preschool Anxiety Scale (Parent report for ages 0 to 4)
timeFrame: Baseline
measure: 5C.i.6 Symptomatology & HRQOL - Spence Children's Anxiety Scale; Preschool Anxiety Scale (Parent report for ages 0 to 4)
timeFrame: Change from baseline at 6 months
measure: 5C.i.12 Symptomatology & HRQOL - Spence Children's Anxiety Scale; Preschool Anxiety Scale (Parent report for ages 0 to 4)
timeFrame: Change from baseline at 12 months
measure: 5C.ii.0 Symptomatology & HRQOL - Spence Children's Anxiety Scale (Parent report for 5 years and older)
timeFrame: Baseline
measure: 5C.ii.6 Symptomatology & HRQOL - Spence Children's Anxiety Scale (Parent report for 5 years and older)
timeFrame: Change from baseline at 6 months
measure: 5C.ii.12 Symptomatology & HRQOL - Spence Children's Anxiety Scale (Parent report for 5 years and older)
timeFrame: Change from baseline at 12 months
measure: 5C.iii.0 Symptomatology & HRQOL - Spence Children's Anxiety Scale (8 years and older)
timeFrame: Baseline
measure: 5C.iii.6 Symptomatology & HRQOL - Spence Children's Anxiety Scale (8 years and older)
timeFrame: Change from baseline at 6 months
measure: 5C.iii.12 Symptomatology & HRQOL - Spence Children's Anxiety Scale (8 years and older)
timeFrame: Change from baseline at 12 months
measure: 5D.i.0 Symptomatology & HRQOL - Mood and Feelings Questionnaire (Short Version) (Parent Report on Child, ages 6-18 years).
timeFrame: Baseline
measure: 5D.i.6 Symptomatology & HRQOL - Mood and Feelings Questionnaire (Short Version) (Parent Report on Child, ages 6-18 years).
timeFrame: Change from baseline at 6 months
measure: 5D.i.12 Symptomatology & HRQOL - Mood and Feelings Questionnaire (Short Version) (Parent Report on Child, ages 6-18 years).
timeFrame: Change from baseline at 12 months
measure: 5D.ii.0 Symptomatology & HRQOL - Mood and Feelings Questionnaire (Short Version) (Child Self Report, ages 6-18 years).
timeFrame: Baseline
measure: 5D.ii.6 Symptomatology & HRQOL - Mood and Feelings Questionnaire (Short Version) (Child Self Report, ages 6-18 years).
timeFrame: Change from baseline at 6 months
measure: 5D.ii.12 Symptomatology & HRQOL - Mood and Feelings Questionnaire (Short Version) (Child Self Report, ages 6-18 years).
timeFrame: Change from baseline at 12 months
measure: 6A.i.0 Phenotypic & Clinical Information - Weight (ages 0 to 20 years)
timeFrame: Baseline
measure: 6A.i.6 Phenotypic & Clinical Information - Weight (ages 0 to 20 years)
timeFrame: Change from baseline at 6 months
measure: 6A.i.12 Phenotypic & Clinical Information - Weight (ages 0 to 20 years)
timeFrame: Change from baseline at 12 months
measure: 6A.ii.0 Phenotypic & Clinical Information - Length (ages 0 to 2 years)
timeFrame: Baseline
measure: 6A.ii.6 Phenotypic & Clinical Information - Length (ages 0 to 2 years)
timeFrame: Change from baseline at 6 months
measure: 6A.ii.12 Phenotypic & Clinical Information - Length (ages 0 to 2 years)
timeFrame: Change from baseline at 12 months
measure: 6A.iii.0 Phenotypic & Clinical Information - Height (ages 2 to 20 years)
timeFrame: Baseline
measure: 6A.iii.6 Phenotypic & Clinical Information - Height (ages 2 to 20 years)
timeFrame: Change from baseline at 6 months
measure: 6A.iii.12 Phenotypic & Clinical Information - Height (ages 2 to 20 years)
timeFrame: Change from baseline at 12 months
measure: 6A.iv.0 Phenotypic & Clinical Information - Weight-for-length (ages 0 to 2 years)
timeFrame: Baseline
measure: 6A.iv.6 Phenotypic & Clinical Information - Weight-for-length (ages 0 to 2 years)
timeFrame: Change from baseline at 6 months
measure: 6A.iv.12 Phenotypic & Clinical Information - Weight-for-length (ages 0 to 2 years)
timeFrame: Change from baseline at 12 months
measure: 6A.v.0 Phenotypic & Clinical Information - Body mass index (ages 2 to 20 years)
timeFrame: Baseline
measure: 6A.v.6 Phenotypic & Clinical Information - Body mass index (ages 2 to 20 years)
timeFrame: Change from baseline at 6 months
measure: 6A.v.12 Phenotypic & Clinical Information - Body mass index (ages 2 to 20 years)
timeFrame: Change from baseline at 12 months
measure: 6B.i.6 Phenotypic & Clinical Information - Number of hospitalisations
timeFrame: 6 months
measure: 6B.i.12 Phenotypic & Clinical Information - Number of hospitalisations
timeFrame: 12 months
measure: 6B.ii.6 Phenotypic & Clinical Information - Length of hospitalisations
timeFrame: 6 months
measure: 6B.ii.12 Phenotypic & Clinical Information - Length of hospitalisations
timeFrame: 12 months
measure: 6B.iii.6 Phenotypic & Clinical Information - Number of emergency department presentations
timeFrame: 6 months
measure: 6B.iii.12 Phenotypic & Clinical Information - Number of emergency department presentations
timeFrame: 12 months
Other outcomes:
Locations:
city: Randwick
country: Australia
facility: Sydney Children's Hospital
state: New South Wales
Study officials:
affiliation: University of New South Wales
name: Michael J Coffey
role: PRINCIPAL_INVESTIGATOR
affiliation: University of New South Wales
name: Chee (Keith) Y Ooi
role: PRINCIPAL_INVESTIGATOR
References:
citation: Traini I, Chan SY, Menzies J, Hughes J, Coffey MJ, Katz T, McKay IR, Ooi CY, Leach ST, Krishnan U. Evaluating the Dietary Intake of Children With Esophageal Atresia: A Prospective, Controlled, Observational Study. J Pediatr Gastroenterol Nutr. 2022 Aug 1;75(2):221-226. doi: 10.1097/MPG.0000000000003498. Epub 2022 Jun 1.
citation: Coffey MJ, McKay IR, Doumit M, Chuang S, Adams S, Stelzer-Braid S, Waters SA, Kasparian NA, Thomas T, Jaffe A, Katz T, Ooi CY. Evaluating the Alimentary and Respiratory Tracts in Health and disease (EARTH) research programme: a protocol for prospective, longitudinal, controlled, observational studies in children with chronic disease at an Australian tertiary paediatric hospital. BMJ Open. 2020 Apr 14;10(4):e033916. doi: 10.1136/bmjopen-2019-033916.