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OpenTrials
Completed

NCT Number: NCT02118935

Nutritive Effects of Prebiotics on Early Postnatal Behavioral Measures of Tolerance

The study is intended to measure infant comfort, behavior, and sleep when consuming study formula with prebiotics compared to infants who consume a study formula without the prebiotics.

Completed

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Key information

Conditions

Behavioral Measures of Tolerance

Age range

14 day–35 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwest Arkansas Pediatric Clinic, Fayetteville, Arkansas, 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, 14-35 days of age at baseline
  • Term infant with birth weight of a minimum of 2500 grams
  • Solely formula-fed
  • Signed Informed Consent and Protected Health Information authorization

Exclusion criteria

  • History of underlying metabolic or chronic disease, congenital malformation, or immunocompromised
  • Feeding difficulties or formula intolerance
  • Maternal history of illicit drug use or psychiatric disease

Treatment and study plan

Previously marketed cow's mlik-based infant formula

Other

Marketed cow's milk-based infant formula with prebiotics

Other

Primary outcomes

  1. Sleep Measures (Amount of time awake and asleep in a 72 hour period)

    Time frame: 14 weeks

  2. Infant State (Infant behavior over a 72 hour period)

    Time frame: 14 weeks

Secondary outcomes

  1. Achieved Weight

    Time frame: 14 weeks

    Total weight gain

  2. Achieved Length

    Time frame: 14 weeks

    Total length gain

  3. Achieved Head Circumference

    Time frame: 14 weeks

    Total head circumference gain

  4. Formula Intake

    Time frame: 14 weeks

  5. Fecal microbiome

    Time frame: Baseline and 112 days of age

  6. Medically-confirmed Adverse Events

    Time frame: 14 weeks

  7. Salivary Cortisol levels

    Time frame: 70 and 120 days of age

  8. Temperament - Infant Behavior Questionnaire

    Time frame: Once at 112 days of age

  9. Sleep Characteristics

    Time frame: 14 weeks

    Amount of waking and sleeping, number of waking and sleep episodes

Sponsors and collaborators

Lead sponsor

Mead Johnson Nutrition

Industry

Collaborators

  • University of Kansas Medical Center

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Apr 21, 2014
Registry last updated
Jun 24, 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.