Growth and Tolerance of Hypoallergenic Formulas

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01354366
• Date of registration: 13/05/2011
• Primary sponsor: Mead Johnson Nutrition
• Public title: Growth and Tolerance of Hypoallergenic Formulas
• Scientific title: The Effects on Growth and Tolerance of Hypoallergenic Formulas Fed to Term Infants
• Date of first enrolment: July 2011
• Target sample size: 405
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT01354366
• Study type: Observational
• Study design: Observational Model: Cohort, Time Perspective: Prospective

Countries of recruitment

United States

Contacts

• Name: Timothy Cooper, M.D.
• Affiliation: Mead Johnson Nutrition

Key inclusion & exclusion criteria

Inclusion Criteria:

- Singleton, 12-16 days of age at randomization

- Term infant with birth weight of a minimum of 2500 grams

- Solely formula fed

- Signed Informed Consent and Protected Health Information

Exclusion Criteria:

- History of underlying metabolic or chronic disease or immunocompromised

- Feeding difficulties or formula intolerance



Age minimum: N/A
Age maximum: 16 Days
Gender: Both

Health Condition(s) or Problem(s) studied

Growth of Term Infants

Intervention(s)

Other: Infant formula

Primary Outcome(s)

Body weight measured at each study visit [Time Frame: 3.5 months]

Secondary Outcome(s)

Body Length and Head Circumference measured at each study visit [Time Frame: 3.5 months]

Medically-confirmed adverse events collected throughout the study period [Time Frame: 3.5 months]

Parental Product Assessment Questionnaire completed at Study Visit 2 [Time Frame: once]

Recall of infant formula intake at each study visit [Time Frame: 3.5 months]

Recall of stool characteristics and tolerance at each study visit [Time Frame: 3.5 months]

Secondary ID(s)

3383-1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors