Clinical trial NCT03703583: Infant Feeding Practice and Gut Comfort Study
Official title: Infant Feeding Practice and Gut Comfort: a Multi-country, Cross-sectional Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Infants
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2018-10-12
Enrollment: 2804
Sex: ALL
Minimum age (years): 6
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy normal developing male and female full-term infants

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.

Eligibility criteria: 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

Primary outcomes:
measure: An index score of overall GI symptom burden
timeFrame: single time point between 6 weeks to 4 months
Secondary outcomes:
measure: GI Symptoms
timeFrame: single time point between 6 weeks to 4 months
measure: Stool characteristics
timeFrame: one day recall before study visit
measure: Physician-reported and parent-reported Colic
timeFrame: Single time point between 6 weeks to 4 months
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria University
city: Assiut
country: Egypt
facility: Assuit University
city: Cairo
country: Egypt
facility: Ain Shams University
city: Cairo
country: Egypt
facility: Cairo University
city: Tanta
country: Egypt
facility: Tanta University
city: Zagazig
country: Egypt
facility: Zagazig University
city: Chennai
country: India
facility: Apollo Children's Hospital
city: Kolkata
country: India
facility: ICH Hospital
city: Thāne
country: India
facility: Dr Praveen Gokhales Childrens Clinic and Vaccination Centre
city: Yogyakarta
country: Indonesia
facility: Faculty of Medicine Universitas Gadjah Mada
city: Kuala Lumpur
country: Malaysia
facility: University of Malaya
city: Islamabad
country: Pakistan
facility: PIMS
city: Karachi
country: Pakistan
facility: National Institute of Child Health
city: Lahore
country: Pakistan
facility: The Children Hospital & Institute of Child Health
city: Rawalpindi
country: Pakistan
facility: BBH
city: Quezon City
country: Philippines
facility: St.Luke'S College of Medicine
Study officials:
affiliation: Universitair Ziekenhuis Brussel
name: Yvan Vandenplas
role: STUDY_CHAIR
References: