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Completed

NCT Number: NCT01122654

Growth and Tolerance of Cow Milk-Based Infant Formulas

This clinical trial will assess growth, tolerance and adverse events of cow milk-based infant formulas in healthy, term infants.

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Key information

Conditions

Body Weight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

12 day–16 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Birmingham Pediatric Associates, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Singleton, 12-16 days of age at randomization
  • Term infant with birth weight of minimum of 2500 g
  • Solely formula fed
  • Signed Informed Consent and Protected Health Information

Exclusion criteria

  • History of underlying metabolic or chronic disease or immunocompromised
  • Acute infection
  • Feeding difficulties or formula intolerance

Treatment and study plan

Primary outcomes

  1. Body weight measured on calibrated infant scale at each study visit

Secondary outcomes

  1. Twenty-four hour recall of infant formula intake at each study visit

  2. Medically-confirmed adverse events collected throughout the study period

  3. Twenty-four hour recall of stool characteristics (number and consistency) and tolerance at each study visit

  4. Parental Product Assessment Questionnaire completed at Study Visit 2

    Assessment of physical properties of product and infant's reaction during consumption.

  5. Body Length and Head Circumference measured at each study visit

Sponsors and collaborators

Lead sponsor

Mead Johnson Nutrition

Industry

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
May 13, 2010
Registry last updated
Jan 31, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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