A randomised, controlled, double-blind trial to investigate the effects of a new infant formula on growth, tolerance and safety in healthy term infants. - Mercurius

utricia Research - Centre for Specialised Nutrition0 sites121 target enrollmentTBD

Overview

Trial is onging in other countries

Registry

who.int

Start Date

TBD

End Date

December 16, 2014

Last Updated

2 years ago

Study Type

Interventional

Sponsor

utricia Research - Centre for Specialised Nutrition

•Healthy term infants (gestational age \>\= 37 1/7 and \<\= 42 6/7 weeks) \- Age \<\= 35 days (preferably as soon as possible after birth) \- Birth weight within normal range for gestational age and sex (10th to 90th percentile according to local applicable growth charts) \- Infants who are exclusively formula fed (mothers who have chosen not to breastfeed or mothers who ended breastfeeding by time of inclusion) or \- Infants who are exclusively breastfed and whose mothers are willing to exclusively breastfeed at least till their infant is 13 weeks of age (and preferably till 17 weeks of age).
•For the sub\-study:
•Once 176 infants receiving study product have been included in the main study, inclusion in the sub\-study will start. The inclusion criterium \*\*Age \<\= 35 days (preferably as soon as possible after birth)\*\* will no longer be valid and be replaced by: \*\*Age \<\= 14 days (preferably as soon as possible after birth)\*\*.

•\- Infants known to have current or previous illnesses/conditions or intervention which could interfere with the study or its outcome parameters, such as gastrointestinal malformations, congenital metabolic disorders, immune deficiency or major surgery, as per investigator\*s clinical judgement \- Infants whose mother is known to suffer from hepatitis B or human immunodeficiency virus (HIV)