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

September 13, 2017 updated by: Nutricia Research
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

252

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Bischofshofen, Austria
        • Private Practice
      • Eferding, Austria
        • Private Practice
      • Hallein, Austria
        • Private Practice
      • Linz, Austria
        • Private Practice
      • Salzburg, Austria
        • Private Practice
      • Salzburg, Austria
        • Reinhold Rauscher
  • Poland
      • Bialystok, Poland
        • Poliklinika Ginekologiczno-Poloznicza Sp. Z.O.O Sp.K
      • Krakow, Poland
        • Centrum Medyczne Promed
  • Turkey
      • Ankara, Turkey
        • Sağlık Bilimleri Üniversitesi Ankara Eğitim ve Araştırma Hastanesi
      • Bursa, Turkey
        • Uludağ Üniversitesi Tıp Fakültesi
      • Istanbul, Turkey
        • Haseki Eğitim ve Araştırma Hastanesi
      • Istanbul, Turkey
        • Istanbul Florence Nightingale Hastanesi
      • Istanbul, Turkey
        • Medipol Mega Universite 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
        • Sağlık Bilimleri Üniversitesi Ümraniye Eğitim ve Araştırma Hastanesi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 hour to 1 month (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Healthy infants: fully or partly formula fed
Other: Infant formula

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stool consistency measured by Amsterdam Stool Scale.
Time Frame: 15 months
Will be reported in diaries completed by the parents.
15 months
Crying time
Time Frame: 15 months
Will be reported in diaries completed by the parents.
15 months
Stool frequency
Time Frame: 15 months
Will be reported in diaries completed by the parents.
15 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Eating behaviour
Time Frame: 15 months
Baby Eating Behaviour Questionnaire
15 months
Parental experience of child behaviour
Time Frame: 15 months
PedsQL,
15 months
Impact on family life
Time Frame: 15 months
FamPedsQL
15 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nutricia Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2016

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

August 30, 2016

First Submitted That Met QC Criteria

September 20, 2016

First Posted (Estimate)

September 22, 2016

Study Record Updates

Last Update Posted (Actual)

September 14, 2017

Last Update Submitted That Met QC Criteria

September 13, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • EBB15YE89845

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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