Single arm, open label, multi-centre intervention trial to evaluate the tolerance and acceptability of a high energy, nutrient enriched infant formula.

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The outcome parameters of this study are:<br /><br>- daily stool frequency<br /><br>- daily stool consistency<br /><br>- daily incidence and intensity of gastrointestinal symptoms: vomiting,<br /><br>regurgitation, abdominal distension, flatulence, diarrhoea and constipation</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The safety outcome parameter in this study is the occurrence of (serious)<br /><br>adverse events<br /><br>Other outcome parameter are:<br /><br>- Compliance: daily study formula intake (current and new formula)<br /><br>- Convenience: a convenience questionnaire for the caretaker or nursing staff<br /><br>on Day 8.</p><br>

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