Evaluation of a Novel Human Milk Fortifier in Preterm Infants

Abbott

Status and phase: Completed; Phase 3

Conditions: Preterm Infants

Treatments: Other: Control human milk fortifier; Other: Experimental human milk fortifier

Study type: Interventional

Funder types: Industry

Identifiers

NCT01373073

AK37

Details and patient eligibility

About

The purpose of this study is to assess growth of preterm infants fed human milk supplemented with an experimental human milk fortifier.

Enrollment: 147 patients

Sex: All

Ages: Under 21 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 700-1500g birth weight
• 33 weeks or less gestational age
• Appropriate for gestational age
• Initiate enteral feeds of human milk by 21 days of life
• Mother provided exclusive human milk feeds
• Parents allow both human milk and study human milk fortifier
• Singleton or twin birth

Exclusion criteria

• Feeding preterm infant formula or non-study human milk fortifier
• Expected at facility less than 15 days
• Congenital anomalies/disease affecting growth and development
• 5 minute APGAR of 4 or less
• Steroid use
• ECMO
• Grade III or IV PVH/IVH
• Mechanical ventilator dependency
• Maternal incapacity
• History of major surgery
• Asphyxia
• Confirmed NEC or sepsis
• Use of probiotics

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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147 participants in 2 patient groups

Experimental Human Milk Fortifier

Experimental group

Description:

Experimental human milk fortifier to be added to human milk

Treatment:

Other: Experimental human milk fortifier

Control Human Milk Fortifier

Active Comparator group

Description:

Control human milk fortifier to be added to human milk

Treatment:

Other: Control human milk fortifier