NL-OMON27338
Not yet recruiting
Not Applicable
A randomized, controlled, double-blind parallel group trial to study the effects of an infant formula containing partially hydrolysed proteins on growth and tolerance in healthy term infants
FrieslandCampina0 sites276 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- FrieslandCampina
- Enrollment
- 276
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
N/A
Investigators
Eligibility Criteria
Inclusion Criteria
- •Full\-term infants (born at gestational age \=37 weeks).
- •Healthy birthweight (according to WHO Child Growth Standards): between 2500 and 4200 g, retrieved from medical records
- •Boys and girls
- •Apparently healthy at birth and screening
- •Weight\-for\-age Z\-score (WAZ), weight\-for\-length (WHZ), and length\-for\-age (LAZ) Z\-scores at screening within the normal range according to WHO Child Growth Standards (i.e. \-2 \= WAZ,WHZ,LAZ \= 2\)
- •Age at enrolment: \=28 days of age
- •Exclusively formula fed for at least 5 days prior to inclusion
- •Exclusively formula fed during the entire intervention period
- •Parents agreeing to initiate complementary feeding after finalization of the study
- •Being available for follow up until the age of approximately 3\.5 months
Exclusion Criteria
- •Gestational age \<37 weeks
- •Birth weight \<2500 g or \>4200 g
- •Age at enrolment: \>28 days
- •Severe acquired or congenital diseases, mental or physical disorders, including cow’s milk protein allergy, lactose intolerance and diagnosed medical conditions that are known to affect growth (i.e. GI disorders)
- •Illness at screening/inclusion
- •Incapability of parents to comply with the study protocol
- •Illiterate parents (i.e. not able to read and write in local language)
- •Participation in another clinical trial
- •Unwillingness to accept the formula supplied by the study as the only formula for their child during study participation
- •infants fed a special diet other than standard, non\-hydrolysed, cow’s or goat’s milk based infant formula
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Phase 2
A randomised, controlled, double-blind, parallel group, multi-country study to investigate the effects of an infant formula containing partially hydrolysed proteins on growth, safety, and tolerance in healthy term infantsGrowth, Weight gainWeight gainNL-OMON45527utricia Research12
Active, not recruiting
Not Applicable
A randomized, double-blind, controlled, parallel group, 12-week treatment study to compare the efficacy and safety of the combination of indacaterol 150 µg once daily with open label tiotropium 18 µg once daily versus open label tiotropium 18 µg once daily in patients with moderate to severe chronic obstructive pulmonary disease - INTRUST 1EUCTR2008-006976-31-DEovartis Pharma Services AG1,126
Active, not recruiting
Not Applicable
A randomized, double-blind, controlled, parallel group, 12-week treatment study to compare the efficacy and safety of the combination of indacaterol 150 µg once daily with open label tiotropium 18 µg once daily versus open label tiotropium 18 µg once daily in patients with moderate-to-severe chronic obstructive pulmonary disease - INTRUST 2EUCTR2008-008447-26-NLovartis Pharma Services AG1,126
Active, not recruiting
Not Applicable
A randomized, double-blind, controlled, parallel group, 12-week treatment study to compare the efficacy and safety of the combination of indacaterol 150 µg once daily with open label tiotropium 18 µg once daily versus open label tiotropium 18 µg once daily in patients with moderate-to-severe chronic obstructive pulmonary disease - INTRUST 2EUCTR2008-008447-26-SKovartis Pharma Services AG1,126
Active, not recruiting
Not Applicable
A randomized, double-blind, controlled, parallel group, 12-week treatment study to compare the efficacy and safety of the combination of indacaterol 150 µg once daily with open label tiotropium 18 µg once daily versus open label tiotropium 18 µg once daily in patients with moderate-to-severe chronic obstructive pulmonary disease - INTRUST 2Chronic Obstructive Pulmonary Disease (COPD)MedDRA version: 9.1Level: LLTClassification code 10010952Term: COPDEUCTR2008-008447-26-HUovartis Pharma Services AG