Clinical trial NCT02911454: Assess the Effects of Infant Formula on Infant Stool Characteristics, Behaviour and Parental Experience in Everyday Situations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Nutricia Research
Sponsor class: INDUSTRY
First posted: 2016-09-22
Enrollment: 252
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: A prospective, multi-country, open label study to describe the stool characteristics and behaviour as well as the parents' experience in infants receiving a recently launched infant formula in a real life situation.


Eligibility criteria: Inclusion Criteria:

* Healthy term infants, gestational age up to and including 37 weeks and 42 weeks and below. Healthy is defined as "no supervision or medical treatment by a medical specialist. Further more to be determined by HCP.
* Birth weight between 2.5 - 4.5 KG (within normal range for gestational age and sex)
* Infants up to 6 weeks of postnatal age (Including day 42)
* Receiving exclusively or at least 1 complete infant formula feeding per day at study inclusion (retrospectively exclusively or partly formula fed)
* Willingness to change from their regular infant formula to study product
* Parents' or legal guardians' aged up to and including 18 years, written, informed consent.

Exclusion Criteria:

* Infants with a congenital condition and / or previous or current illness and (or) medication that could interfere with the study
* Infants with established or suspected cows milk allergy, lactose intolerance, galactosaemia or infants on a prescribed fibre free (e.g. prebiotic oligosaccharides) diet
* Participation in any other studies involving investigational or marketed products concomitantly or within 2 weeks prior to entry into the study
* Investigator's uncertainty about the willingness of the parents / legal guardians to comply with the protocol requirements.

Primary outcomes:
measure: Stool consistency measured by Amsterdam Stool Scale.
timeFrame: 15 months
measure: Crying time
timeFrame: 15 months
measure: Stool frequency
timeFrame: 15 months
Secondary outcomes:
measure: Eating behaviour
timeFrame: 15 months
measure: Parental experience of child behaviour
timeFrame: 15 months
measure: Impact on family life
timeFrame: 15 months
Other outcomes:
Locations:
city: Bischofshofen
country: Austria
facility: Private practice
city: Eferding
country: Austria
facility: Private practice
city: Hallein
country: Austria
facility: Private practice
city: Linz
country: Austria
facility: Private practice
city: Salzburg
country: Austria
facility: Private practice
city: Salzburg
country: Austria
facility: Reinhold Rauscher
city: Bialystok
country: Poland
facility: Poliklinika Ginekologiczno-Poloznicza Sp. Z.O.O Sp.K
city: Krakow
country: Poland
facility: Centrum Medyczne Promed
city: Ankara
country: Turkey
facility: Sağlık Bilimleri Üniversitesi Ankara Eğitim ve Araştırma Hastanesi
city: Bursa
country: Turkey
facility: Uludağ Üniversitesi Tıp Fakültesi
city: Istanbul
country: Turkey
facility: Haseki Eğitim ve Araştırma Hastanesi
city: Istanbul
country: Turkey
facility: Istanbul Florence Nightingale Hastanesi
city: Istanbul
country: Turkey
facility: Medipol Mega Üniversite Hastanesi
city: Istanbul
country: Turkey
facility: Sağlık Bilimleri Üniversitesi Kanuni Sultan Süleyman Eğitim ve Araştırma Hastanesi
city: Istanbul
country: Turkey
facility: Sağlık Bilimleri Üniversitesi Süleymaniye Kadın Doğum ve Çocuk Hastalıkları Eğitim ve Araştırma Hastanesi
city: Istanbul
country: Turkey
facility: Sağlık Bilimleri Üniversitesi Ümraniye Eğitim ve Araştırma Hastanesi
Study officials:
References: