NCT02490852

Brief Summary

This is a growth study of full-term infants. The growth of infants fed the investigational formula will be compared with infants fed a control formula. A breastfeeding arm will be used as reference.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
304

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2015

Typical duration for not_applicable

Geographic Reach
4 countries

18 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

First Submitted

Initial submission to the registry

June 29, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 7, 2015

Completed
25 days until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 22, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 22, 2018

Completed
Last Updated

May 21, 2019

Status Verified

November 1, 2018

Enrollment Period

3.1 years

First QC Date

June 29, 2015

Last Update Submit

May 20, 2019

Conditions

Growth

Outcome Measures

Primary Outcomes (1)

  • Weight gain

    16 weeks

Study Arms (3)

Investigational Infant formula

EXPERIMENTAL

Healthy term infants fed exclusively the investigational Infant Formula

Other: Investigational infant formula

Commercially available Infant formula

ACTIVE COMPARATOR

Healthy term infants fed exclusively a commercially available Infant Formula

Other: Active Comparator: Commercially available Infant formula

Human milk

ACTIVE COMPARATOR

Healthy term infants fed exclusively human milk

Other: Active Comparator: Human milk

Interventions

Investigational infant formulaOTHER

fed ad libitum

Investigational Infant formula
Active Comparator: Commercially available Infant formulaOTHER

fed ad libitum

Commercially available Infant formula
Active Comparator: Human milkOTHER

fed ad libitum

Human milk

Eligibility Criteria

AgeUp to 13 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy full term infant (37-42 weeks of gestational age)
  • Birth weight 2,500 to 4,500 g
  • Infant's mother willing and able to exclusively breast feed or infant's parent(s)/caregiver(s) willing to exclusively use randomized infant formula during study participation
  • Parent(s)/caregiver(s) able to attend visits and willing to complete the subject diary
  • Informed consent signed by parent(s)/caregiver(s)

You may not qualify if:

  • Congenital illness or malformation that may affect infant feeding or normal growth
  • Gastrointestinal disorders
  • Suspected or known allergy to milk protein for formula groups
  • Known food allergies in parents or siblings for formula groups
  • Multiples
  • Readmission to hospital for longer than 3 days for another reason than hyperbilirubinemia prior to enrollment
  • Infant participating in another clinical study
  • Infant's family unable to comply with the protocol according to the investigators's assessment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Unknown Facility

Vienna, Austria

Location

Unknown Facility

Dubrovnik, Croatia

Location

Unknown Facility

Kutina, Croatia

Location

Unknown Facility

Split, Croatia

Location

Unknown Facility

Vukovar, Croatia

Location

Unknown Facility

Zadar, Croatia

Location

Unknown Facility

Zagreb, Croatia

Location

Unknown Facility

Zaprešić, Croatia

Location

Unknown Facility

Đakovo, Croatia

Location

Unknown Facility

Bramsche, Germany

Location

Unknown Facility

Hamm, Germany

Location

Unknown Facility

Herford, Germany

Location

Unknown Facility

Mannheim, Germany

Location

Unknown Facility

Mönchengladbach, Germany

Location

Unknown Facility

Wesel, Germany

Location

Unknown Facility

Wuppertal, Germany

Location

Unknown Facility

Barcelona, Spain

Location

Unknown Facility

Madrid, Spain

Location

Study Officials

  • Falco Panzer, Dr. Med.

    Kinderärztliche Gemeinschaftspraxis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2015

First Posted

July 7, 2015

Study Start

August 1, 2015

Primary Completion

August 22, 2018

Study Completion

August 22, 2018

Last Updated

May 21, 2019

Record last verified: 2018-11

Locations

CR(8)AU(1)ES(2)DE(7)