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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03661736




Registration number
NCT03661736
Ethics application status
Date submitted
22/08/2018
Date registered
7/09/2018
Date last updated
21/12/2020

Titles & IDs
Public title
Growth of Infants With Cow's Milk Allergy Fed an Amino Acid-based Formula Containing Two Human Milk Oligosaccharides
Scientific title
Growth of Infants With Cow's Milk Allergy Fed an Amino Acid-based Formula Containing Two Human Milk Oligosaccharides: Comparison With World Health Organization (WHO) Growth Standards in an Observational, Single-arm Study
Secondary ID [1] 0 0
17.09.CLI
Universal Trial Number (UTN)
Trial acronym
PLATYPUS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cow Milk Allergy 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Allergies

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - Food for Specific Medical Purpose

Other interventions: Food for Specific Medical Purpose
Infants aged 1 to 8 months with moderate-to-severe cow's milk allergy fed an amino acid-based formula with two added human milk oligosaccharides
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The weight-for-age z-score (WAZ) compared with the WHO 2006 Child Growth Standard
Timepoint [1] 0 0
Comparison of baseline WAZ vs WAZ at 4 months
Secondary outcome [1] 0 0
Length-for-age Z-scores (LAZ) compared with the WHO 2006 Child Growth Standard
Timepoint [1] 0 0
1, 2, 3, 4 months from baseline and at 12 months of age

Eligibility
Key inclusion criteria
1. Full term infant (37 weeks = gestation = 42 weeks)
2. 2500g = birth weight = 4500g
3. Having obtained written informed consent form the infant's parents or legally authorized representatives (LAR).
4. Infant aged between 1 and 8 months.
5. Exclusively formula-fed at time of enrolment; or CMPA infant receiving partial breastfeeding and infant's mother having independently elected before enrolment to exclusively formula feed.
6. Infants with physician-diagnosed CMPA as per standard clinical practice:
Minimum age
1 Month
Maximum age
8 Months
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Previous treatment with AAF > 72 hours
2. Known underlying medical condition that would impair growth (as per physician's assessment, e.g. unstable congenital heart disease, cystic fibrosis, metabolic disorder, chronic liver disease etc.)
3. Demonstrated chronic malabsorption which is not due to CMPA.
4. Other significant pre-natal and/or serious post-natal disease other than CMPA before enrolment (per investigator's medical decision).
5. Infants whose parents or caregivers who cannot give informed consent or who cannot be expected to comply with study procedures.
6. Treatment with systemic corticosteroids (oral or intravenous) for >72 hours within 4 weeks before enrolment (topical corticosteroids allowed)
7. Infants taking probiotic preparations for > 72 hour within 4 weeks before enrolment
8. Currently participating or having participated in another clinical trial since birth.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/04/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/10/2020
Sample size
Target
Accrual to date
Final
33
Recruitment in Australia
Recruitment state(s)
Westmea
Recruitment hospital [1] 0 0
The Children's Hospital at Westmead - Sydney
Recruitment postcode(s) [1] 0 0
2145 - Sydney

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Société des Produits Nestlé (SPN)
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The main aim of this study is to provide longitudinal growth data in infants with moderate-to-severe cow's milk allergy fed an amino acid-based formula with two added human milk oligosaccharides.
Trial website
https://clinicaltrials.gov/study/NCT03661736
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03661736