The primary objective of this study is to investigate equivalence of weight gain from randomisation until the age of 17 weeks in infants receiving the test product compared to infants receiving the control product. Secondary objectives of this study…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
effect op de groei van zuigelingen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Weight gain in grams per day from randomisation until 17 weeks of age [g/day].
Secondary outcome
Gain from randomisation until 17 weeks of age of: - Recumbent length [mm/day] -
Head circumference [mm/day] - Mid-upper arm circumference [mm/day] - Skin folds
(subscapular, triceps) [mm/day]. Total weight gain in gram from randomization
until 12 months of age [g/day]. Gain from randomization until 12 months of age
of: Recumbent length [mm/day] - Head circumference [mm/day] - Mid-upper arm
circumference [mm/day] - Skin folds (subscapular, triceps) [mm/day]. Sum of
skin folld thickness: triceps, biceps, suprilliac, subscapular [mm/day].
Z-scores of anthropometric parameters until 17 weeks and 12 months of age: -
Weight-for-age z-scores - Weight-for-length z-scores - Length-for-age z-scores
- BMI-for-age z-scores - Head circumference-for-age z-scores - Mid-upper arm
circumference-for-age z-scores - Skinfold-for-age z-scores (subscapular,
triceps) Number, type and severity of (serious) adverse events Use of
medication and nutritional supplements Gastrointestinal tolerance parameters
utnil 17 weeks of age (via a diary) including: - Occurrence and severity of
gastrointestinal symptoms (cramps, diaper/nappy rash, regurgitation, and
vomiting) - Stool frequency - Stool consistency - Occurrence of diarrhoea and
constipation.
Background summary
Breast-feeding is considered as the gold standard for infant nutrition, as it
provides the best nutritional components delivered in the most efficient way
and it also conveys the best immunological protection from a healthy mother to
her child. However, breast-feeding is not always possible or appropriate due to
circumstance and for such cases infant formula is the logical solution. It is
known that breast-fed infants have a different growth pattern later in life as
compared to formula-fed infants, and this may be related to differences in
nutrient composition between human milk and infant formula. The lipid (fat)
composition and structure of human milk, in particular, is different from that
in infant formula. This study will evaluate the effect of the new infant
formula on the infant*s growth, and will also evaluate the intestine complaints
or symptoms. In addition, this study will measure the effect of this new infant
formula on immune status and gut microbiota.
Sub-study: Infants gain weight faster in early infancy than at any subsequent
age, and judging whether weight gain is within normal limits during the first 4
months is part of the safety assessment of infant formula studies. Most infants
show a period of weight loss immediately after birth, before this rapid weight
gain begins. The majority of infants regain their birth weight within the first
14 days postpartum. To make sure that this period of weight loss immediately
after birth and regaining of birth weight is included into the safety
assessment, it has been decided to include a minimal fixed number of infants up
until 14 days of age at inclusion in the study, in addition to the total number
of infants recruited until 35 days of age at inclusion as originally planned.
This will allow us to better establish safety of the test product compared to
the control product in this sub-population of young infants. The importance of
this period is also reflected in the guidelines of some countries, which state
that safety studies with infant formula should be done in infants starting
formula up until 14 days of age (guidelines of the American Academy of
Paediatrics (American Academy of Paediatrics, 1988). Due to the differences in
growth rates breastfed infants are significantly leaner then formula-fed
infants between 6 and 12 months of aged. In addition to growth, assessment of
body composition has shown that the growth differences between 6 and 12 months
of age are likely due to less rapid decrease in adiposity in formula-fed
infants compared to breastfed infants. In order to gain insight into the
possible long-term effects on growth of the new formula product given up to 17
weeks of age, an optional vist at 12 months of age has been added to the study.
Study objective
The primary objective of this study is to investigate equivalence of weight
gain from randomisation until the age of 17 weeks in infants receiving the test
product compared to infants receiving the control product. Secondary objectives
of this study are: - To investigate equivalence of other growth parameters from
randomisation until the age of 17 weeks in infants receiving test product
compared to infants receiving the control product - To assess gastrointestinal
tolerance and safety from randomisation until the age of 17 weeks in infants
receiving the test product compared to infants receiving the control product.
To investigate efficacy on weight gain from randomisation until the age of 12
months in infants receiving te test product compared to infants receiving the
control product until 17 weeks of age.
Study design
This is a randomised, controlled, double-blind, parallel-group, prospective,
multi-country, intervention study.
Intervention
Infants who will be randomised equally to the following groups:
- Test group: receiving test product
- Control group: receiving control product
Infants who are exclusively breastfed and whose mothers are willing to
exclusively breastfeed for at least till their infant is 13 weeks of age (and
preferably 17 weeks of age) will enter the breastfeeding reference group (not
applicable for the sub-study). These infants will not be randomised.
Study burden and risks
There are no special risks for the infants. Potential inconveniences of the
study include emotional stress during the voluntary blood drawing procedure.
Uppsalalaan 12
Utrecht 3584 CT
NL
Uppsalalaan 12
Utrecht 3584 CT
NL
Listed location countries
Age
Inclusion criteria
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)**.
Exclusion criteria
- 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)
Design
Recruitment
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 |
|---|---|
| CCMO | NL42715.072.12 |