Nutritional Study in Preterm Infants

Abbott

Status and phase: Completed; Phase 3

Conditions: Preterm Infants

Treatments: Other: Preterm infant formula with added soluble lipids; Other: Preterm infant formulas and discharge formulas

Study type: Interventional

Funder types: Industry

Identifiers

NCT00707837

AK15

Details and patient eligibility

About

An evaluation of a preterm infant formula containing ingredients similar to those found in breastmilk

Enrollment: 206 patients

Sex: All

Ages: Under 21 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Birthweight 500-1800 g
• Less than 33 wks gestational age
• Enteral feeding initiated by 21 days of life
• Asymmetrical small-for-gestational age (SGA) infants and infants with patent ductus arteriosus (PDA) are eligible to participate
• Singleton or twin births only
• Infant is 21 days of age or less at time of randomization

Exclusion criteria

• Serious congenital abnormalities that may affect growth and development
• Grade III or IV intraventricular hemorrhage (IVH)
• Maternal incapacity
• History of major surgery
• Extracorporeal membrane oxygenation (ECMO)
• Asphyxia
• Confirmed NEC or positive blood cultures at the time of randomization

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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206 participants in 2 patient groups

Infant Formula

Experimental group

Description:

Preterm infant formulas containing lipid soluble compounds

Treatment:

Other: Preterm infant formula with added soluble lipids

Preterm formulas

Active Comparator group

Description:

Standard preterm infant formula and discharge formulas

Treatment:

Other: Preterm infant formulas and discharge formulas