Infant Feeding Practice and Gut Comfort Study
- Conditions
- Healthy Infants
- Interventions
- Other: There is no intervention in this observational study.
- Registration Number
- NCT03703583
- Lead Sponsor
- Société des Produits Nestlé (SPN)
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2804
- 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).
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Exclusively/predominantly Breastfeeding group There is no intervention in this observational study. - Exclusively/predominantly Formula feeding group There is no intervention in this observational study. -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (16)
Faculty of Medicine Universitas Gadjah Mada
🇮🇩Yogyakarta, Indonesia
Alexandria University
🇪🇬Alexandria, Egypt
Assuit University
🇪🇬Assiut, Egypt
Apollo Children's Hospital
🇮🇳Chennai, India
National Institute of Child Health
🇵🇰Karachi, Pakistan
The Children Hospital & Institute of Child Health
🇵🇰Lahore, Pakistan
BBH
🇵🇰Rawalpindi, Pakistan
Cairo University
🇪🇬Cairo, Egypt
University of Malaya
🇲🇾Kuala Lumpur, Malaysia
PIMS
🇵🇰Islamabad, Pakistan
St.Luke'S College of Medicine
🇵🇭Quezon City, Philippines
Tanta University
🇪🇬Tanta, Egypt
Zagazig University
🇪🇬Zagazig, Egypt
ICH Hospital
🇮🇳Kolkata, India
Dr Praveen Gokhales Childrens Clinic and Vaccination Centre
🇮🇳Thāne, India
Ain Shams University
🇪🇬Cairo, Egypt