Infant Colic
Conditions
Keywords
Infant formula, Partially hydrolized protein infant formula
Brief summary
Randomized, parallel, double-blind clinical trial, comparing a partially hydrolyzed serum proteins infant formula with a conventional formula with intact protein in healthy infants that suffer from colic
Detailed description
Demonstrate that an infant formula with partially hydrolized cow's milk protein of serum proteins is equivalent to an intact protein formula in healthy children in terms of safety of use and suitability, to prove that it can be a alternative with digestive health benefits in healthy children with infant colic.
Interventions
DIETARY_SUPPLEMENTPartially hydrolyzed formula (pHF)
Infant formula with partially hydrolyzed protein
DIETARY_SUPPLEMENTStandard formula (SF)
Infant formula with intact protein
Sponsors
Laboratorios Ordesa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Weeks to 8 Weeks
Healthy volunteers
No
Inclusion criteria
* Children diagnosed as nursing colic according to Roma IV criteria. * Infants who have received breastfeeding at least 2 weeks. * Infants who at the time of inclusion in the study whose parents/legal guardians voluntarily decide not to continue exclusive breastfeeding or only maintain it in residual form (less than 20% of the daily intake, one breast intake per day). * Full-term infants (\>37 weeks of gestation). * Infants with weight suitable for their gestational age (2500-4500g). * Normal APGAR score: 7-10. * Infants between 2 and 8 weeks of life. * Infants whose parents/legal guardians have signed informed consent. * Infants with good availability of clinical follow-up until the end of the study.
Exclusion criteria
* Infants fed from birth with exclusive infant formula. * Infants with congenital diseases or malformations that may affect growth. * Infants with major medical conditions that require chronic medication or close medical checks. * Infants who have taken any type of antibiotics or probiotics prior to the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Growth standard calculated z-scores | From baseline to 3 months after starting with the formula | Using Z-scores including: weight (g), size (cm) and cranial perimeter (cm) |
| Symptoms associated with infant colic | From baseline to 3 months after starting with the formula | Hours of crying, wakefulness, sleep for 24 hours, by adapting Barr's crying letter |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Infant illness and infection outcomes | Baseline, 1, 2 and 3 months follow-up visit, and 6, 9 months old | Specific parent-reported infant symptoms (digestive, respiratory or other infections) |
| Behaviour/temperament test | 1, 6, 12 months old | Infant Behavior Questionnaire-Revised test: For this study, the very short form validated in Spanish that includes 37 items will be applied. Parents are asked to rate the frequency of specific, temperament-related behaviors observed during the last week. |
| Growth standard calculated z-scores | At 6, 9 and 12 months old. | Using Z-scores including: weight (g), size (cm) and cranial perimeter (cm) |
| Food survey at the first year of life | At 12 months old | Investigator will conduct a food consumption frequency survey |
| Product safety | At 1, 2 and 3 months follow-up visit, and 6, 9 months old | Assessment of acceptance of the formula and record of potential adverse or side effects related to taking the product. |
| Assessment of supplementary food | At 6 and 9 months old | Investigator will collect data from the timetable for introduction of the different food groups |
| Gatrointestinal tolerance recording | Baseline, 1, 2 and 3 months follow-up visit, and 6, 9 months old | Record in the patient's diary stool patterns (depositional rhythm and quality of faeces) |
Countries
Spain
Contacts
Primary ContactRoser De Castellar, MD
Outcome results
None listed