No registrations found.
ID
Source
Brief title
Health condition
Healthy term infants
Sponsors and support
Intervention
Outcome measures
Primary outcome
To investigate equivalence of weight gain from randomisation until the age of 17 weeks.
Secondary outcome
1. To investigate equivalence of other growth parameters until the age of 17 weeks.
2. To assess gastrointestinal tolerance and safety until the age of 17 weeks.
3.To investigate efficacy in weight gain at 12 months
Background summary
In this study infant formula containing a new fat blend is compared with the same infant formula containing the standard fat blend.
The main parameter being studied is growth. Furthermore, gastrointestinal tolerance and safety are studied. The results are also compared to a breastfeeding reference group.
The infants will be included in the study until they are 35 days of age, study product intake will be until they are 4 months of age. There will be a follow-up period of two weeks after last product intake. Subsequently, subjects will be asked if they are willing to participate in an optional extension visit at 12 months of age.
During the intervention period, parents will be asked to fill in a diary with information on some of the parameters, and a questionnaire. Furthermore, they will be asked to collect a stool sample 2 to 3 times during the study. Voluntary blood draw can be taken at 3 and 12 months of age.
Study objective
Based on the human milk composition, Nutricia Research has developed a new infant formula with a new fat blend, more similar to that of human milk. This new formula is currently being studied for safety and its effects on growth.
The comparator used in the study is a standard infant formula containing the standard fat blend.
Study design
1. V2 (Week 4);
2. V3 (Week 8);
3. V4 (week 13);
4. V5 (Week 17);
5. V6 (12 months).
Intervention
Duration of intervention: 13-17 weeks.
Intervention group: Standard infant formula containing the new fat blend.
Control group: Standard infant formula containing the standard fat blend.
Reference group (no intervention): Human milk.
Danone Nutricia Research
Utrecht 3508 TC
The Netherlands
+31(0)302095000
register.clinicalresearchnutricia@danone.com
Danone Nutricia Research
Utrecht 3508 TC
The Netherlands
+31(0)302095000
register.clinicalresearchnutricia@danone.com
Inclusion criteria
1. Healthy term (gestational age >= 37 1/7 and <= 42 6/7 weeks);
2. Age <= 35 days (preferably as soon as possible after birth);
3. Birth weight within normal range (10th to 90th percentile);
4. Exclusively formula fed (mothers who have chosen not to breastfeed or mothers who ended breastfeeding by time of inclusion);
OR
Exclusively breastfed (mothers willing to exclusively breastfeed at least till 13 weeks of age (and preferably till 17 weeks of age);
5. Written informed consent from parent(s) and/or legal guardian, aged ≥ 18 years.
Exclusion criteria
1. Known current or previous illnesses/conditions or intervention which could interfere with the study or its outcome parameters;
2. Mother known to suffer from hepatitis B or human immunodeficiency virus (HIV) with a minimum number of formula fed infants ≤ 14 days
3. Need to be fed with a special diet other than standard (non hydrolysed) cow¡®s milk-based infant formula;
4. Currently participating or have participated in any other study involving investigational or marketed products;
5. Incapability of the parent(s) to comply with study protocol or investigator's uncertainty about the willingness or ability of the parent(s) to comply with the protocol requirements.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL3521 |
| NTR-old | NTR3683 |
| Other | Danone Research : EPI.1.C/A |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
Summary results
1. Heijning, B.v.d., et al., 51st ESPGHAN Annual Meeting. Journal of Pediatric Gastroenterology and Nutrition, 2018. 66: p. 1110-1111.
2. Breij, L.M., et al., ESPGHAN 49th ANNUAL MEETING of the European Society for Paediatric Gastroenterology, Hepatology and Nutrition. Journal of Pediatric Gastroenterology and Nutrition, 2016. 62: p. 867-868.
3. Breij, L.M., et al., An infant formula with large, milk phospholipid-coated lipid droplets containing a mixture of dairy and vegetable lipids supports adequate growth and is well tolerated in healthy, term infants. Am J Clin Nutr, 2019. 109(3): p. 586-596.