NCT02911454

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
252

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Jul 2016

Typical duration for not_applicable healthy

Geographic Reach
3 countries

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2016

Completed
23 days until next milestone

First Posted

Study publicly available on registry

September 22, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

September 14, 2017

Status Verified

March 1, 2017

Enrollment Period

1.1 years

First QC Date

August 30, 2016

Last Update Submit

September 13, 2017

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

  • Stool consistency measured by Amsterdam Stool Scale.

    Will be reported in diaries completed by the parents.

    15 months

  • Crying time

    Will be reported in diaries completed by the parents.

    15 months

  • Stool frequency

    Will be reported in diaries completed by the parents.

    15 months

Secondary Outcomes (3)

  • Eating behaviour

    15 months

  • Parental experience of child behaviour

    15 months

  • Impact on family life

    15 months

Study Arms (1)

Healthy infants: fully or partly formula fed

EXPERIMENTAL
Other: Infant formula

Interventions

Infant formulaOTHER
Healthy infants: fully or partly formula fed

Eligibility Criteria

Age1 Hour - 6 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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)
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Private practice

Bischofshofen, Austria

Location

Private practice

Eferding, Austria

Location

Private practice

Hallein, Austria

Location

Private practice

Linz, Austria

Location

Private practice

Salzburg, Austria

Location

Reinhold Rauscher

Salzburg, Austria

Location

Poliklinika Ginekologiczno-Poloznicza Sp. Z.O.O Sp.K

Bialystok, Poland

Location

Centrum Medyczne Promed

Krakow, Poland

Location

Sağlık Bilimleri Üniversitesi Ankara Eğitim ve Araştırma Hastanesi

Ankara, Turkey (Türkiye)

Location

Uludağ Üniversitesi Tıp Fakültesi

Bursa, Turkey (Türkiye)

Location

Haseki Eğitim ve Araştırma Hastanesi

Istanbul, Turkey (Türkiye)

Location

Istanbul Florence Nightingale Hastanesi

Istanbul, Turkey (Türkiye)

Location

Medipol Mega Üniversite Hastanesi

Istanbul, Turkey (Türkiye)

Location

Sağlık Bilimleri Üniversitesi Kanuni Sultan Süleyman Eğitim ve Araştırma Hastanesi

Istanbul, Turkey (Türkiye)

Location

Sağlık Bilimleri Üniversitesi Süleymaniye Kadın Doğum ve Çocuk Hastalıkları Eğitim ve Araştırma Hastanesi

Istanbul, Turkey (Türkiye)

Location

Sağlık Bilimleri Üniversitesi Ümraniye Eğitim ve Araştırma Hastanesi

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Infant Formula

Intervention Hierarchy (Ancestors)

Milk SubstitutesBeveragesDiet, Food, and NutritionPhysiological PhenomenaFood, FormulatedFoods, SpecializedFoodInfant FoodFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2016

First Posted

September 22, 2016

Study Start

July 1, 2016

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

September 14, 2017

Record last verified: 2017-03

Locations

AU(6)PL(2)TU(8)