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OpenTrials
Completed

NCT Number: NCT02405572

Feeding Tolerance Evaluation

Crossover study of 2 infant formulas

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Key information

Conditions

Healthy

Age range

Up to 2 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pedia Research, Owensboro, Kentucky, United States

Loading trial locations.

About this study

Exclusively formula-fed infants will participate in two 2-week feeding periods of 2 infant formulas. Daily tolerance records will be kept by caregivers.

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)
  • 0-2 months (birth-56 days) of age on enrollment
  • Infant exclusively formula-fed for at least 2 days prior to enrollment
  • Having obtained his/her legal representative's informed consent

Exclusion criteria

  • Known or suspected cow-milk allergy
  • Congenital illness or malformation
  • Significant prenatal and/or postnatal disease
  • Currently participating in another clinical study

Treatment and study plan

Infant Formula

Other

infant formulas

Primary outcomes

  1. stool consistency

    Time frame: 2 weeks

    caregivers will document on diary records

Secondary outcomes

  1. spit-up pattern

    Time frame: 2 weeks

    caregivers will document on diary records

  2. formula intake

    Time frame: 2 weeks

    caregivers will document on diary records

  3. adverse events

    Time frame: 2 weeks

    assessed throughout the study

  4. stool pattern

    Time frame: 2 weeks

    caregivers will document on diary records

  5. mood

    Time frame: 2 weeks

    caregivers will document on diary records

  6. sleep pattern

    Time frame: 2 weeks

    caregivers will document on diary records

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Important dates

Study start
2015
Primary completion
2016
First posted
Apr 1, 2015
Registry last updated
May 12, 2016

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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