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Study to investigate the nutritional efficacy and suitability of infant formulae in healthy full-term infants.


- candidate number6774
- NTR NumberNTR2128
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR2-dec-2009
- Secondary IDsAll.3.C/A Danone Research B.V.
- Public TitleStudy to investigate the nutritional efficacy and suitability of infant formulae in healthy full-term infants.
- Scientific TitleStudy to investigate the nutritional efficacy and suitability of infant formulae in healthy full-term infants.
- ACRONYMGiraffe study
- hypothesisThe 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) studiedHealthy full-term infants
- Inclusion criteria1. 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 criteria1. 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 receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-dec-2009
- planned closingdate31-dec-2011
- Target number of participants156
- InterventionsDuration 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 outcomeWeight gain.
- Secondary outcome1. Recumbent length gain;
2. Increase in head circumference.
- TimepointsScreening, baseline, visits on 4, 8, 12, 16, and 52 weeks.
- Trial web site
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESMBA, PhD, MSc Lilian van Tuyl
- CONTACT for SCIENTIFIC QUERIESMBA, PhD, MSc Lilian van Tuyl
- Sponsor/Initiator Danone Nutricia Research
- Funding
(Source(s) of Monetary or Material Support)
Danone Nutricia Research
- PublicationsN/A
- Brief summaryThis 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
- RECORD2-dec-2009 - 11-dec-2016


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