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Completed

NCT Number: NCT01583673

Growth of Infants Fed an Amino Acid Infant Formula

The primary objective of the clinical trial is to compare growth in infants (expressed as weight gain in g/day) consuming a new Amino Acid Formula to infants consuming a commercially available hypoallergenic formula over a period of 4 months.

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Key information

Conditions

Growth

Age range

Up to 17 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alabama Clinical Therapeutics, 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

  • Healthy newborn infant
  • Full-term (>= 37 weeks gestation)
  • Birth weight between >= 2500 and < =4500 g
  • 0-17 days of age on enrolment (day 0 is day of birth)
  • Infant's mother has elected not to breastfeed and to exclusively formula-feed infant
  • Study explained and written information provided with Caregiver demonstrating understanding of the given information
  • Informed consent signed (parent/legal representative)

Exclusion criteria

  • Congenital illness or malformation that may affect infant feeding and/or normal growth
  • Suspected or known allergy to cow's milk protein
  • Significant pre-natal and/or post-natal disease
  • Any readmission to hospital (except for hyperbilirubinemia) prior to enrolment
  • Infant receiving prescription medication (with exception of topical antibiotics and/or treatment for thrush) or frequent use of over the counter medications except vitamin and mineral supplements
  • Infant currently participating in another conflicting clinical study
  • Infant's family who in the Investigator's assessment cannot be expected to comply with the protocol

Treatment and study plan

Amino Acid Formula

Other

Subjects will be fed the assigned study formula from enrollment to 4 months (112 days) of age.Infants will be fed orally, ad libitum with the assigned formula

Primary outcomes

  1. Weight Gain

    Time frame: 4 months

    Mean weight gain (g/day) from enrollment to 4 months of age

Secondary outcomes

  1. tolerance

    Time frame: 4 months

    Tolerance will be evaluated based on formula intake, stool characteristics, vomiting/spitting up and behavior from enrollment to 4 months.

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Official study title

Assessment of Growth of Infants Fed an Amino Acid Based Formula

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Apr 24, 2012
Registry last updated
Oct 21, 2015

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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