Nutritive Effects of Prebiotics on Early Postnatal Behavioral Measures of Tolerance

Not Applicable

Completed

• Conditions: Behavioral Measures of Tolerance
• Interventions: Other: Marketed cow's milk-based infant formula with prebiotics; Other: Previously marketed cow's mlik-based infant formula

• Registration Number: NCT02118935
• Lead Sponsor: Mead Johnson Nutrition

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-04-04
• Study First Submitted QC: 2014-04-18
• Study First Posted: 2014-04-21
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-22
• Last Update Posted: 2016-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 161

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Marketed cow's milk-based infant formula with prebiotics	Marketed cow's milk-based infant formula with prebiotics	-
Previously marketed cow's milk-based infant formula	Previously marketed cow's mlik-based infant formula	-

Primary Outcome Measures

Name	Time	Method
Sleep Measures (Amount of time awake and asleep in a 72 hour period)	14 weeks
Infant State (Infant behavior over a 72 hour period)	14 weeks

Secondary Outcome Measures

Name	Time	Method
Achieved Weight	14 weeks	Total weight gain
Achieved Length	14 weeks	Total length gain
Achieved Head Circumference	14 weeks	Total head circumference gain
Formula Intake	14 weeks
Fecal microbiome	Baseline and 112 days of age
Medically-confirmed Adverse Events	14 weeks
Salivary Cortisol levels	70 and 120 days of age
Temperament - Infant Behavior Questionnaire	Once at 112 days of age
Sleep Characteristics	14 weeks	Amount of waking and sleeping, number of waking and sleep episodes

Trial Locations

Locations (7)

Northwest Arkansas Pediatric Clinic; 🇺🇸 Fayetteville, Arkansas, United States

Woburn Pediatrics; 🇺🇸 Woburn, Massachusetts, United States

The Jackson Clinic; 🇺🇸 Jackson, Tennessee, United States

Pediatric Associates of Mt. Carmel; 🇺🇸 Cincinnati, Ohio, United States

Universty of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States

Norwich Pediatrics; 🇺🇸 Norwich, Connecticut, United States

Deaconess Clinic; 🇺🇸 Evansville, Indiana, United States