This is a single-centre, prospective, randomized, open-label, controlled trial of 200 infants 42±7 days of age. Subjects will be randomized to one of two open label feeding intervention group: * Intact Cow's Milk Protein Formula Group (CMFG) (n = 100) or * Partially Hydrolysed Whey Formula Group (pHFG) (n = 100).
Atopic dermatitis (AD) affects 15 - 30% of children. Approximately 45% of these cases have an onset within the first 6 months of life and 60% develop within the first year (Bieber 2010). Besides environmental factors, the aetiology of AD has been found to be associated with genetic variants involved in skin barrier function defect and inflammation, leading to dry skin with increases in susceptibility to environmental exposures (Bieber 2008). Partially hydrolysed cow's milk (whey) protein infant formula (pHF) has been shown to be effective in prevention of AD, both among at-risk and healthy infants (Exl, Deland et al. 2000, von Berg, Koletzko et al. 2003, Jingrana and Dunjina 2015). However, to date there are no published pediatric data to document the relationship between partially hydrolysed protein formulas and skin barrier function, specifically evaluating the effect of pHF on Trans-epidermal Water Loss (TEWL) among infants. Therefore, this study aims to evaluate the effect on skin barrier function as measured by TEWL and we hypothesize that infants consuming partially hydrolysed starter formula will have lower TEWL when compared infants consuming intact cow's milk protein starter formula.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
200
Study product will be provided as powder, reconstituted with water by parents/caregivers according to label instructions, and consumed orally. Study participants will continue this feeding regimen for 4 months.
Study product will be provided as powder, reconstituted with water by parents/caregivers according to label instructions, and consumed orally. Study participants will continue this feeding regimen for 16 months.
Shanghai Tonxin Pediatric Clinic Co. Ltd
Shanghai, Shanghai Municipality, China
Skin barrier function
Change in Trans-epidermal water loss (TEWL)
Time frame: Baseline (age 42 ± 7 days) to Study Month 4 (age 6 months)
Weight
Weight in grams and corresponding Z-score according to WHO reference standards and/or local standardized growth charts will be calculated.
Time frame: Baseline (age 42 ± 7 days) to Study Month 4 (age 6 months) - in both randomized groups and until Study Month 15 (age 18 months) in pHF group only
Length
Length in centimeters and corresponding Z-score according to WHO reference standards and/or local standardized growth charts will be calculated.
Time frame: Baseline (age 42 ± 7 days) to Study Month 4 (age 6 months) - in both randomized groups and until Study Month 15 (age 18 months) in pHF group only
Head Circumference
Head circumference in centimeters and corresponding Z-score according to WHO reference standards and/or local standardized growth charts will be calculated.
Time frame: Baseline (age 42 ± 7 days) to Study Month 4 (age 6 months) - in both randomized groups and until Study Month 15 (age 18 months) in pHF group only
Infant health-related quality of life
Assessed through a parent-reported, validated questionnaire called Infant Toddler Quality of Life questionnaire 47-item short-form (ITQOL-SF47). For each concept, item responses are scored, summed, and transformed on a scale from 0 (worst health) to 100 (best health).
Time frame: Baseline (age 42 ± 7 days) to Study Month 4 (age 6 months) - in both randomized groups and until Study Month 15 (age 18 months) in pHF group only
Infant health-related quality of life
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Assessed through the Happy Growth Index Questionnaire with each question rated on a Likert scale from strongly disagree to strongly agree.
Time frame: Baseline (age 42 ± 7 days) to Study Month 4 (age 6 months) - in both randomized groups and until Study Month 15 (age 18 months) in pHF group only
Incidence and severity of Atopic Dermatitis (AD) and other allergic manifestations (CMF group)
Incidence will be gathered from standard Adverse Event (AE) reporting. Atopic Dermatitis (AD) will be diagnose based on the Williams diagnostic criteria of International Study of Asthma and Allergies in Childhood (ISAAC). Severity of AD will be assessed using the SCORing Atopic Dermatitis (SCORAD) index, which consists of the extent and intensity of the disorder and subjective symptoms.
Time frame: aseline (age 42 ± 7 days) to Study Month 4 (age 6 months) - in both randomized groups and until Study Month 15 (age 18 months) in pHF group only
Infant gut comfort
Using the Infant Gastrointestinal Symptom Questionnaire (IGSQ)-13.
Time frame: Baseline (age 42 ± 7 days) to Study Month 4 (age 6 months)
Toddler gut comfort
Using the Toddler Gut Comfort Questionnaire.
Time frame: Study Month 9 (age 12 months) and Study Month 15 (age 18 months)
Stool consistency
Parents will record for 3 consecutive days after each bowel movement in a 3-Day Stool Diary the stool consistency on a validated 5-point scale from 1-watery to 5-hard.
Time frame: Baseline (age 42 ± 7 days) to Study Month 4 (age 6 months)
Formula acceptance and satisfaction
Formula intake, acceptability and satisfaction recorded using the Milk Intake and Satisfaction Questionnaire.
Time frame: Baseline (age 42 ± 7 days) to Study Month 4 (age 6 months) - in both randomized groups and until Study Month 15 (age 18 months) in pHF group only
Safety assessment: Adverse events (AEs)
Using standard adverse events (AEs) reporting for safety assessment.
Time frame: Baseline (age 42 ± 7 days) to Study Month 4 (age 6 months) - in both randomized groups and until Study Month 15 (age 18 months) in pHF group only