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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON27027

Enrollment

Registered

2012-11-16

Start date

2012-11-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

malnutrition, failure to thrive

Interventions

During a 3-days baseline period subjects will receive the current high energy, nutrient enriched infant formula. GI symptoms, stool frequency, stool consistency and the amount of current formula consu

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age 0 to 18 months (including 0 and 18 months); 2. 37 to 42 weeks gestation at birth; 3. Currently receiving a high energy, nutrient enriched infant formula (current Infatrini) for at least 7 days prior to the baseline visit (day -2); 4. Expected to require a high energy infant formula for at least 10 days after baseline visit; 5. Consuming, on average, at least 50% of their energy intake from the study feed; 6. Either enterally fed (naso-enteric tube, gastrostomy, jejunostomy) or orally fed (bottle fed); 7. Written informed consent from parents/ guardians that have legal custody of the child; 8. Parents/ guardians should have good knowledge of Dutch language.

Exclusion criteria

Exclusion criteria: 1. Body weight > 9kg; 2. Proven cow‟s milk allergy; 3. Lactose intolerance; 4. Galactosaemia; 5. Other medical or dietary contraindication to a polymeric, high energy, nutrient enriched infant formula (eg major hepatic or renal dysfunction); 6. 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; 7. Any surgery planned within 10 days after baseline visit; 8. Investigator's uncertainty about the willingness or ability of the parent/caregiver to comply with the protocol requirements; 9. Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study.

Design outcomes

Primary

Measure	Time frame
Tolerance and acceptability.	—

Secondary

Measure	Time frame
Safety parameters: 1. Occurrence of (serious) adverse events. Other parameters: 2. Compliance (daily current and new formula intake); 3. Convenience (convenience questionnaire).	—

Contacts

Public ContactWillemien Sinke

Danone Research - Centre for Specialised Nutrition Bosrandweg 20

willemien.sinke@nutricia.com+31 (0)317 467955

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)