Safety and suitability of a partially hydrolysed, cow’s milk based infant formula Nutritional, Metabolic, Endocrine
Conditions
Interventions
This study is a multicenter, randomised, controlled, double-blind equivalence study including two study arms:
Arm 1 (test formula): partially hydrolysed, cow’s milk-based infant formula
Arm 2 (contr
Sponsors
Comac Medical
Eligibility
Sex/Gender
All
Age
1 Days to 28 Days
Inclusion criteria
Inclusion criteria: 1. Gestational age 37+0 weeks – 42+0 weeks at birth 2. Birthweight between 2,500 and 4,500 g 3. Boys and girls 4. Healthy at birth and screening, e.g., major congenital anomalies, absence of serious illness requiring hospitalization, no metabolic or gastrointestinal conditions affecting growth or nutrition, stable vital signs. 5. Weight-for-age Z-score (WAZ), weight-for-length Z-score (WHZ), and length-for-age Z-score (LAZ) at screening within the normal range according to WHO Child Growth Standards (i.e., between -2 and 2) 6. Age at enrolment =28 days of age 7. Exclusively formula fed for at least 5 days prior to inclusion 8. Exclusively formula fed during the entire intervention period 9. Parents agreeing to initiate complementary feeding after finalization of the study 10. Written informed consent from parent(s) and/or legal guardian(s) aged =18 years
Exclusion criteria
Exclusion criteria: 1. Severe acquired or congenital diseases, mental or physical disorders, including cow's milk protein allergy (CMPA), lactose intolerance and diagnosed medical conditions that are known to affect growth, including severe gastroesophageal reflux (throwing up or spitting up more than a teaspoon of milk >8 times daily 2. Incapability of parents to comply with the study protocol 3. Inability to complete study diaries or comply with study procedures 4. Participation in another clinical trial 5. Unwillingness to accept the formula supplied by the study as the only formula for their child during study participation 6. Infants fed a special diet other than standard, non-hydrolysed, cow's or goat's milk based infant formula
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weight measured using electronic scales at baseline, 30, 60, 90 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Length measured using an infantometer at baseline, 30, 60, 90 days;Head circumference measured using unelastic tape at baseline,30,60,90 days;BMI measured using weight divided by length squared at baseline, 30, 60, 90 days;Feeding tolerance and gastrointestinal-related behaviors measured using the Infant Gastrointestinal Symptom Questionnaire (IGSQ-13) at baseline, 30, 60, 90 days;Formula intake measured using a feeding diary at Days 1-14, 22-29, 52-59, 82-89 | — |
Countries
Bulgaria
Contacts
Public ContactHayriye Tunca-Ates
Outcome results
None listed