To evaluate the use of a hypoallergenic infant formula containing an extensively hydrolyzed protein source for routine nutrition.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
TRIPLE
Enrollment
61
Azienda Ospedaliera "Ospedale Policlinico Consorziale" di Bari
Bari, Apulia, Italy
Enteral intake (ml/kg/day)
Time frame: Daily for 14 days
Body Weight (g)
Time frame: Daily for 14 days
Feeding Tolerance
Gastric residuals, regurgitation(\>1 ml), fecal output (number of stools per day)
Time frame: Daily for 14 days
Respiratory status
Apnea and/or bradycardia events, use of supplemental oxygen, use of mechanical ventilation
Time frame: Daily for 14 days
Gut Inflammation
Fecal calprotectin, alpha and beta defensins, TNF alpha, gastric ultrasound
Time frame: Once at Study Day 14
Confirmed or suspected sepsis or necrotizing enterocolitis
Time frame: Daily for 14 days
Date of hospital discharge
Time frame: Once at hospital discharge
Growth
length (cm) and head circumference (cm)
Time frame: Study Days 1, 7, and 14
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