Recruitment

Recruitment Status
Completed

Inclusion Criterias

Infant's mother, before the 14th day of the child's life, has elected not to breastfeed
Gestational age over 37 weeks
Singleton birth
...
Infant's mother, before the 14th day of the child's life, has elected not to breastfeed
Gestational age over 37 weeks
Singleton birth
Infant randomized in to a treatment group can expected to be exclusively fed the formula from enrolment until 16 weeks old
Having obtained his/her legal representative's informed consent
Birthweight between 2500g and 4500g
Healthy new-born infant
Infant is less14 days old on day of enrollment

Exclusion Criterias

Significant pre-natal and/or post-natal disease
Re-hospitalisation for more than 2 days in the first 14 days of life. (Exceptionally, infants re-hospitalized because of jaundice may be enrolled in the study).
Congenital illness or malformation that may affect normal growth
...
Significant pre-natal and/or post-natal disease
Re-hospitalisation for more than 2 days in the first 14 days of life. (Exceptionally, infants re-hospitalized because of jaundice may be enrolled in the study).
Congenital illness or malformation that may affect normal growth
Receiving infant formula containing probiotics and/or prebiotics at the time of enrolment
Currently participating in another clinical trial
Receiving antibiotic treatment at time of enrolment or in the 5 previous days.

Summary

Conditions
Infants Growth
Type
Interventional
Phase
Phase 3
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Participation Requirements

Age
Younger than 14 years
Gender
Both males and females

Description

The infants will be recruited between birth and 14 days of life and will start on the allocated study formula as soon as they are enrolled. In practice this will tend to be immediately after birth. The treatment period, in terms of data necessary for the primary outcome, will be until they reach 16 ...

The infants will be recruited between birth and 14 days of life and will start on the allocated study formula as soon as they are enrolled. In practice this will tend to be immediately after birth. The treatment period, in terms of data necessary for the primary outcome, will be until they reach 16 weeks old. Growth and other measurements will be collected on five separate occasions during this period, ie 2, 4, 8, 12 and 16 weeks of life. Although the study intervention formally ends at 16 weeks, it will be useful to have a follow up visit at 26 weeks to collect further data on the gut microflora in the sub-group of infants who have already provided a stool sample at 8 weeks. This follow-up visit will be of benefit to the subject as they receive a weight check and clinical examination by a paediatrician and will be offered to all subjects (no invasive procedures will be carried out).

Inclusion Criterias

Infant's mother, before the 14th day of the child's life, has elected not to breastfeed
Gestational age over 37 weeks
Singleton birth
...
Infant's mother, before the 14th day of the child's life, has elected not to breastfeed
Gestational age over 37 weeks
Singleton birth
Infant randomized in to a treatment group can expected to be exclusively fed the formula from enrolment until 16 weeks old
Having obtained his/her legal representative's informed consent
Birthweight between 2500g and 4500g
Healthy new-born infant
Infant is less14 days old on day of enrollment

Exclusion Criterias

Significant pre-natal and/or post-natal disease
Re-hospitalisation for more than 2 days in the first 14 days of life. (Exceptionally, infants re-hospitalized because of jaundice may be enrolled in the study).
Congenital illness or malformation that may affect normal growth
...
Significant pre-natal and/or post-natal disease
Re-hospitalisation for more than 2 days in the first 14 days of life. (Exceptionally, infants re-hospitalized because of jaundice may be enrolled in the study).
Congenital illness or malformation that may affect normal growth
Receiving infant formula containing probiotics and/or prebiotics at the time of enrolment
Currently participating in another clinical trial
Receiving antibiotic treatment at time of enrolment or in the 5 previous days.

Locations

Palermo, 90127
Palermo, 90127

Tracking Information

NCT #
NCT01886898
Collaborators
Not Provided
Investigators
Not Provided