Healthy Infants
Conditions
Brief summary
Multi-country, cross-sectional, observational study in diverse geographic locations all over the world.
Detailed description
This is a cross-sectional single time point study. Infants and caregivers who come to a clinic for a routine health visit who wish to participate in the study by signing the consent form and meet all inclusion criteria/exclusion criteria will be enrolled. At the visit, a research staff member will assist the parents to complete (i) Feeding Practice and Gut Comfort Questionnaire and (ii) Infant Gastrointestinal Symptom (IGSQ)-13 items. Additionally, infant's anthropometrics (weight, length, head circumference) will be recorded. These anthropometrics will be measured by the researcher as part of the routine visit.
Interventions
OTHERThere is no intervention in this observational study.
There is no intervention in this observational study.
Sponsors
Société des Produits Nestlé (SPN)
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
6 Weeks to 4 Months
Healthy volunteers
Yes
Inclusion criteria
* Healthy full term (37-42 weeks of gestation) singleton infant. * Postnatal age ≥ 6 weeks and ≤ 4 months * Parent as primary Caregiver and ≥ 18 years old * Exclusively/predominantly breastfeeding or exclusively/predominantly formula feeding of the same type/brand, for at least the past 2 weeks. * Evidence of personally signed and dated informed consent document by the infant's parent(s).
Exclusion criteria
* Chronic illness necessitating medical follow up * Acute ongoing or recent (last 2 weeks) illness necessitating medical follow up * Any known case of food allergy (e.g milk) * Caregivers who are not likely to comply with the study procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| An index score of overall GI symptom burden | single time point between 6 weeks to 4 months | Measured by Validated, standardized infant Gastrointestinal Symptom Questionnaire (IGSQ-13) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| GI Symptoms | single time point between 6 weeks to 4 months | measured by IGSQ-13 questionnaires (An overall index score is calculated from 13 questions in the questionnaire as a measure of total GI symptom burden. The values for the IGSQ index score can range from 13 (low GI burden) to 65 (high GI burden)) |
| Stool characteristics | one day recall before study visit | measured by Feeding Practice and Gut Comfort Questionnaire (frequency and consistency) |
| Physician-reported and parent-reported Colic | Single time point between 6 weeks to 4 months | measured by Feeding Practice and Gut Comfort Questionnaire based on ROME IV diagnosis criteria. Effect of feeding group on the prevalence of colic will be assessed by logistic regression. |
Countries
Egypt, India, Indonesia, Malaysia, Pakistan, Philippines
Outcome results
None listed