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OpenTrials
Completed

NCT Number: NCT00937014

Assessment of Growth of Infants Fed a New Formula

The purpose of this clinical trial is to assess growth (rate of weight gain in grams per day) of infants fed an infant formula with a whey isolate enriched with lactoferrin, during the first four months of life as compared to infants fed a standard infant formula.

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Key information

Conditions

Infant Nutrition Body Weight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

11 day–17 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pedia Research, LLC, Newburgh, Indiana, United States

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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
  • Infant's mother has elected not to breastfeed and baby has been exclusively formula fed a minimum 3 days prior to enrollment
  • Tolerating a cows milk based formula for at least 3 days
  • Study explained and written information provided with Parent/Caregiver demonstrating understanding of the given information
  • Informed consent signed (Parent/Legal representative)
  • Parent/Caregiver has a working freezer
  • Lives within 45 minutes of a study site

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 enrollment
  • Infant has received oral or intravenous antibiotic therapy in the 10 days prior to enrollment
  • Infant receiving prescription medication (with exception of treatment for thrush) or frequent use of over the counter medications except vitamin and mineral supplements
  • Infant currently participating in another clinical study
  • Infant's family who in the Investigator's assessment cannot be expected to comply with the protocol

Treatment and study plan

Standard Infant Formula

Other

Standard infant formula given during the first 9 months of life, as per standard requirement

Test formula

Other

Test formula enriched in lactoferrin given during the first 9 months of life, as per standard requirement.

Primary outcomes

  1. Mean weight gain

    Time frame: 4 months

Secondary outcomes

  1. anthropometry, tolerance, morbidity, blood tests

    Time frame: 9 months

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Official study title

Assessment of Growth of Infants Fed a Starter Formula With a Whey-Isolate Enriched in Lactoferrin

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jul 10, 2009
Registry last updated
Jun 26, 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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