The objective of this study is to evaluate the tolerance and acceptability of the new formula in infants receiving the current formula.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
groeiachterstand, groeivertraging, ontoereikende voedingsinname, verhoogde energiebehoefte
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The outcome parameters of this study are:
- daily stool frequency
- daily stool consistency
- daily incidence and intensity of gastrointestinal symptoms: vomiting,
regurgitation, abdominal distension, flatulence, diarrhoea and constipation
Secondary outcome
The safety outcome parameter in this study is the occurrence of (serious)
adverse events
Other outcome parameter are:
- Compliance: daily study formula intake (current and new formula)
- Convenience: a convenience questionnaire for the caretaker or nursing staff
on Day 8.
Background summary
The composition of Danone's high energy, nutrient enriched infant formula has
recently been adapted in line with recent scientific developments. The improved
(new) formula has a composition comparable to the current formula, except a few
adaptations. For details on these adaptations please see Protocol section 1.2
and Product Information Brochure. Clinical studies have shown that the
currently available formula is safe, well tolerated and promotes growth (see
Product Information Brochure section 4.7). The same profile is to be expected
from the new formula with the slightly altered composition.
The new formula will be launched end of 2012. Infants that are using current
Infatrini at time of the launch will be switched to new Infatrini. No issues
with regards to tolerance are expected in relation to this switch, however it
is considered important by Danone to have descriptive data on tolerance and
acceptability of the new formula prior to this launch in order to support the
introduction of the new formula on the (international) market, especially
considering the vulnerability of the targeted patient group. Results from this
study will be used to support the rationale for full strength transition. In
case the study does demonstrate any tolerance issues after full strength
transition, it will be suggested to switch infants from current to new
Infatrini more gradually.
Study objective
The objective of this study is to evaluate the tolerance and acceptability of
the new formula in infants receiving the current formula.
Study design
This is a single arm, open-label, multi-centre intervention study.
Intervention
In the intervention period the infants will receive the new formula during 7
days.
Study burden and risks
The burden for the subject and parents/ caretakers is limited and the expected
risks are low.
The burden consists of:
- completion of a diary during 10 days. In the diary the parents/ caretakers
are asked to document daily the stool frequency and consistency, the study
formula intake and the absence/ presence of GI symptoms. 1 page in the diary
represents 1 day.
- completion of a convenience questionnaire consiting of 3 multiple-choice
questions during visit 2.
In order to ensure the lowest burden possible, the protocol contains the option
to perform visit 2 at home or per telephone, in case the parents/ caretakers
are unable to come to the hospital with their child for visit 2
If adverse side effects do occur after receiving the new formula, these are
expected to be mild and acceptable for the subjects.
Bosrandweg 20
Wageningen 6704 PH
NL
Bosrandweg 20
Wageningen 6704 PH
NL
Listed location countries
Age
Inclusion criteria
*Age 0 to 18 months (including 0 and 18 months)
*Currently receiving a high energy, nutrient enriched infant formula for at least 7 days prior to the baseline visit (day -2)
*Expected to require a high energy infant formula for at least 10 days after baseline visit
*Consuming, on average, at least 50% of their energy intake from the study feed
*Either enterally fed (nasogastric tube, gastrostomy, jejunostomy) or orally fed (bottle fed)
*Written informed consent from parents/ guardians that have legal custody of the child
*Parents/ guardians should have good knowledge of Dutch language
Exclusion criteria
*Infants less than 37 weeks gestation and requiring specific premature formula at the time of study entry
*Children between 12 and 18 months of age and with a body weight > 9kg that use Infatrini as sole source of nutrition
*Proven cow's milk allergy
*Lactose intolerance
*Galactosaemia
*Other medical or dietary contraindication to a polymeric, high energy, nutrient enriched infant formula (eg major hepatic or renal dysfunction)
*BMR vaccination performed within 14 days prior to baseline visit, any other vaccination performed within 48 hours prior to baseline visit or any vaccination planned within 10 days after baseline visit
*Any surgery planned within 10 days after baseline visit
*Investigator's uncertainty about the willingness or ability of the parent/caregiver to comply with the protocol requirements
*Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study
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 | NL40611.041.12 |