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OpenTrials
Completed

NCT Number: NCT01354366

Growth and Tolerance of Hypoallergenic Formulas

This clinical trial will evaluate two investigational hypoallergenic infant formulas with a differing protein content to determine if they provide normal growth and are well tolerated by term infants as compared to a marketed hypoallergenic formula.

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Key information

Conditions

Growth of Term Infants

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 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

Treatment and study plan

Infant Formula

Other

Primary outcomes

  1. Body weight measured at each study visit

    Time frame: 3.5 months

Secondary outcomes

  1. Recall of infant formula intake at each study visit

    Time frame: 3.5 months

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

    Time frame: 3.5 months

  3. Recall of stool characteristics and tolerance at each study visit

    Time frame: 3.5 months

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

    Time frame: 3.5 months

  5. Parental Product Assessment Questionnaire completed at Study Visit 2

    Time frame: once

Sponsors and collaborators

Lead sponsor

Mead Johnson Nutrition

Industry

Registry information

Official study title

The Effects on Growth and Tolerance of Hypoallergenic Formulas Fed to Term Infants

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
May 16, 2011
Registry last updated
Aug 29, 2013

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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