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

Sponsor
Nutricia Research (Industry)
Overall Status
Completed
CT.gov ID
NCT02911454
Collaborator
(none)
252
Enrollment
16
Locations
1
Arm
13
Actual Duration (Months)
15.8
Patients Per Site
1.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Infant formula
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
252 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Actual Study Start Date :
Jul 1, 2016
Actual Primary Completion Date :
Aug 1, 2017
Actual Study Completion Date :
Aug 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Healthy infants: fully or partly formula fed

Other: Infant formula

Outcome Measures

Primary Outcome Measures

  1. Stool consistency measured by Amsterdam Stool Scale. [15 months]

    Will be reported in diaries completed by the parents.

  2. Crying time [15 months]

    Will be reported in diaries completed by the parents.

  3. Stool frequency [15 months]

    Will be reported in diaries completed by the parents.

Secondary Outcome Measures

  1. Eating behaviour [15 months]

    Baby Eating Behaviour Questionnaire

  2. Parental experience of child behaviour [15 months]

    PedsQL,

  3. Impact on family life [15 months]

    FamPedsQL

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Hour to 6 Weeks
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Private practice Bischofshofen Austria
2 Private practice Eferding Austria
3 Private practice Hallein Austria
4 Private practice Linz Austria
5 Private practice Salzburg Austria
6 Reinhold Rauscher Salzburg Austria
7 Poliklinika Ginekologiczno-Poloznicza Sp. Z.O.O Sp.K Bialystok Poland
8 Centrum Medyczne Promed Krakow Poland
9 Sağlık Bilimleri Üniversitesi Ankara Eğitim ve Araştırma Hastanesi Ankara Turkey
10 Uludağ Üniversitesi Tıp Fakültesi Bursa Turkey
11 Haseki Eğitim ve Araştırma Hastanesi Istanbul Turkey
12 Istanbul Florence Nightingale Hastanesi Istanbul Turkey
13 Medipol Mega Üniversite Hastanesi Istanbul Turkey
14 Sağlık Bilimleri Üniversitesi Kanuni Sultan Süleyman Eğitim ve Araştırma Hastanesi Istanbul Turkey
15 Sağlık Bilimleri Üniversitesi Süleymaniye Kadın Doğum ve Çocuk Hastalıkları Eğitim ve Araştırma Hastanesi Istanbul Turkey
16 Sağlık Bilimleri Üniversitesi Ümraniye Eğitim ve Araştırma Hastanesi Istanbul Turkey

Sponsors and Collaborators

  • Nutricia Research

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nutricia Research
ClinicalTrials.gov Identifier:
NCT02911454
Other Study ID Numbers:
  • EBB15YE89845
First Posted:
Sep 22, 2016
Last Update Posted:
Sep 14, 2017
Last Verified:
Mar 1, 2017

Study Results

No Results Posted as of Sep 14, 2017