A multi-center, double-blind, controlled, parallel-designed, prospective trial intended to evaluate the nutritive effects of a partially hydrolyzed cow's milk protein infant formula on infant fussiness.
A multi-center, double-blind, controlled, parallel-designed, prospective trial intended to evaluate the nutritive effects of a partially hydrolyzed cow's milk protein (PHP) infant formula on infant fussiness. Formula tolerance and intake, sleep characteristics, stool characteristics, parental quality of life, and medically confirmed adverse events will be compared between i two study groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
148
Partially hydrolyzed cow's milk protein
Intact cow's milk protein
Birmingham Pediatric Associates
Birmingham, Alabama, United States
Alabama Clinical Therapeutics
Birmingham, Alabama, United States
DBC Research USA
Miramar, Florida, United States
Fussiness
Daily Diary
Time frame: Study Feeding Days 1 through 7
Fussiness
Daily Diary
Time frame: Study Feeding Days 8-28
Gassiness
Daily Diary
Time frame: Study Feeding Days 1-28
Crying
Daily Diary
Time frame: Study Feeding Days 1-28
Spit-up
Daily Diary
Time frame: Study Feeding Days 1-28
Sleep
Daily Diary
Time frame: Study Feeding Days 1-28
Stool frequency
Daily Diary
Time frame: Study Feeding Days 1-28
Stool consistency
Daily Diary
Time frame: Study Feeding Days 1-28
Study Formula Intake
24-hour Recall of Study Formula Intake
Time frame: Study Feeding Day 7 and Study Feeding Day 25 (+3 days)
Brief Infant Sleep Questionnaire
Revised Short Form (BISQ-R SF)
Time frame: Study Feeding Day 14 (+2 days) and Study Feeding Day 25 (+ 3 days)
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Proactive Clinical Research
Sarasota, Florida, United States
Mid Valley Research Inc.
Moline, Illinois, United States
Frontier Pediatric Research
Lincoln, Nebraska, United States
Meridian Clinical Research
Charleston, South Carolina, United States
Tribe Clinical Research
Greenville, South Carolina, United States
AVIATI Healthcare & Clinical Research
Memphis, Tennessee, United States
South Texas Pediatric Research Group
Del Rio, Texas, United States
...and 1 more locations
Quality of Life Questionnaire
Pediatric Quality of Life Inventory™ Family Impact Module (PedsQL FIM)-Acute
Time frame: Study Feeding Day 7 (+2 days) and Study Feeding Day 25 (+3 days)
Medically confirmed adverse events
Collected from medical records
Time frame: Day 1 through end of feeding