|- candidate number||6774|
|- NTR Number||NTR2128|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||2-dec-2009|
|- Secondary IDs||All.3.C/A Danone Research B.V.|
|- Public Title||Study to investigate the nutritional efficacy and suitability of infant formulae in healthy full-term infants.|
|- Scientific Title||Study to investigate the nutritional efficacy and suitability of infant formulae in healthy full-term infants.|
|- ACRONYM||Giraffe study|
|- hypothesis||The investigational formulae are equivalent to the currently marketed control formula with regard to weight gain of healthy full-term infants during first 16 weeks of life.|
|- Healt Condition(s) or Problem(s) studied||Healthy full-term infants|
|- Inclusion criteria||1. Healthy full-term infants (gestational age > 37 and < 42 weeks, birth weight > 2.5 kg); |
2. Infants with appropriate birth weight within normal range for gestational age and sex;
3. Infants aged <= 14 days at study entry;
4. Infants who are exclusively formula fed (mothers who have chosen not to breastfeed or mothers who ceased breastfeeding by time of inclusion);
5. Written informed consent from both parents.
|- Exclusion criteria||1. Infants with birth weight > 4.5 kg;|
2. Infants diagnosed with a congenital illness or malformation that could affect normal growth;
3. Infants with significant pre- or postnatal disease;
4. Infants that are already participating in another clinical trial;
5. Infants with cows' milk allergy, soy allergy or lactose intolerance.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-dec-2009|
|- planned closingdate||31-dec-2011|
|- Target number of participants||156|
|- Interventions||Duration of intervention: 14-16 weeks.|
Intervention groups: Two investigational formulae with slightly modified composition.
Control group: the control formula is a currently marketed infant formula.
|- Primary outcome||Weight gain.|
|- Secondary outcome||1. Recumbent length gain;|
2. Increase in head circumference.
|- Timepoints||Screening, baseline, visits on 4, 8, 12, 16, and 52 weeks.|
|- Trial web site|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||MBA, PhD, MSc Lilian van Tuyl|
|- CONTACT for SCIENTIFIC QUERIES||MBA, PhD, MSc Lilian van Tuyl|
|- Sponsor/Initiator ||Danone Nutricia Research|
(Source(s) of Monetary or Material Support)
|Danone Nutricia Research|
|- Brief summary||This study aims to investigate the nutritional efficacy and suitability of two infant formulae with slightly modified composition in healthy full-term infants compared to a currently marketed infant formula primarily on weight gain in the first 16 weeks of life. A follow-up visit will take place at 52 weeks of life. During the intervention period parents will be asked to record gastrointestinal tolerance and formula intake. In a subgroup of infants (on a voluntary basis) a blood sample will be collected at the age of 16 weeks for nutritional status and safety.|
|- Main changes (audit trail)||31-3-2014: The first subject was included 12Jan2010 and the last subject was out of the study 3Aug2012.
Danone Research B.V. changed names into Nutricia Research. - AB|
|- RECORD||2-dec-2009 - 11-dec-2016|