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OpenTrials
Completed

NCT Number: NCT01210391

Growth of Infants Fed an Extensively Hydrolyzed 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 extensively hydrolyzed formula (EHF) to infants consuming a commercially available EHF.

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Key information

Conditions

Age range

11 day–4 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Colorado Springs Health Partners, Colorado Springs, Colorado, 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 singleton infant
  • Full-term (>= 37 weeks gestation)
  • Birth weight between >= 2500 and < =4500 g
  • 14 ± 3 days of age on enrollment
  • Infant's mother has elected not to breastfeed
  • baby has been exclusively formula fed a minimum of 3 days prior to enrollment
  • Study explained and written information provided with Parent/Caregiver
  • Informed consent signed (parent/legal representative)

Exclusion criteria

  • Congenital illness or malformation affecting infant feeding and/or 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 IV antibiotic therapy in the 10 days prior to enrollment
  • 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 has received probiotics in the seven days prior to enrollment
  • 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

Extensively hydrolyzed whey infant formula

Other

New hydrolyzed infant formula.

Other names: Baby Formula

Extensively hydrolyzed casein infant formula

Other

Commercially available infant formula.

Other names: Baby Formula

Primary outcomes

  1. Weight Gain

    Time frame: 4 Months

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

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Official study title

Assessment of Growth of Infants Fed a 100% Whey Extensively Hydrolyzed Formula.

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Sep 28, 2010
Registry last updated
Jun 26, 2014

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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