Assess the Effects of Infant Formula on Infant Stool Characteristics, Behaviour and Parental Experience in Everyday Situations

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Other: Infant formula

• Registration Number: NCT02911454
• Lead Sponsor: Nutricia Research

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07
• Study First Submitted: 2016-08-30
• Study First Submitted QC: 2016-09-20
• Study First Posted: 2016-09-22
• Status Verified: 2017-03
• Primary Completion: 2017-08
• Study Completion: 2017-08
• Last Update Submitted: 2017-09-13
• Last Update Posted: 2017-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 252

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Healthy infants: fully or partly formula fed	Infant formula	-

Primary Outcome Measures

Name	Time	Method
Stool consistency measured by Amsterdam Stool Scale.	15 months	Will be reported in diaries completed by the parents.
Crying time	15 months	Will be reported in diaries completed by the parents.
Stool frequency	15 months	Will be reported in diaries completed by the parents.

Secondary Outcome Measures

Name	Time	Method
Impact on family life	15 months	FamPedsQL
Eating behaviour	15 months	Baby Eating Behaviour Questionnaire
Parental experience of child behaviour	15 months	PedsQL,

Trial Locations

Locations (12)

Private practice; 🇦🇹 Salzburg, Austria

Sağlık Bilimleri Üniversitesi Ümraniye Eğitim ve Araştırma Hastanesi; 🇹🇷 Istanbul, Turkey

Medipol Mega Üniversite Hastanesi; 🇹🇷 Istanbul, Turkey

Centrum Medyczne Promed; 🇵🇱 Krakow, Poland

Uludağ Üniversitesi Tıp Fakültesi; 🇹🇷 Bursa, Turkey

Poliklinika Ginekologiczno-Poloznicza Sp. Z.O.O Sp.K; 🇵🇱 Bialystok, Poland

Haseki Eğitim ve Araştırma Hastanesi; 🇹🇷 Istanbul, Turkey

Sağlık Bilimleri Üniversitesi Kanuni Sultan Süleyman Eğitim ve Araştırma Hastanesi; 🇹🇷 Istanbul, Turkey

Sağlık Bilimleri Üniversitesi Süleymaniye Kadın Doğum ve Çocuk Hastalıkları Eğitim ve Araştırma Hastanesi; 🇹🇷 Istanbul, Turkey

Istanbul Florence Nightingale Hastanesi; 🇹🇷 Istanbul, Turkey

Reinhold Rauscher; 🇦🇹 Salzburg, Austria

Sağlık Bilimleri Üniversitesi Ankara Eğitim ve Araştırma Hastanesi; 🇹🇷 Ankara, Turkey