Feeding Study in VLBW Premature Infants

Mead Johnson Nutrition

Status: Terminated

Conditions: VLBW - Very Low Birth Weight Infant

Treatments: Other: Exempt Infant Formula

Study type: Interventional

Funder types: Industry

Identifiers

NCT05744193

3394-1

Details and patient eligibility

About

A multi-center, single-blind, randomized, controlled, parallel-designed, prospective trial to compare growth between preterm infants fed one of three study human milk fortifiers added to human milk

Enrollment: 22 patients

Sex: All

Ages: 168 to 224 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinically and metabolically stable
• Birth weight 700 g to less than or equal to 1,250 g
• Appropriate birth weight for gestational age
• 24 0/7 to 32 0/7 weeks' gestational age at birth
• Exclusively fed human milk
• Signed informed consent and authorization to use and/or disclose PHI

Exclusion criteria

• Metabolic or chronic disease
• 5-minute Apgar score <4
• Major surgery
• Ventilator dependent
• Fluid restriction
• Grade III or IV intraventricular hemorrhage (IVH)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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22 participants in 3 patient groups

Commercial Liquid Human Milk Fortifier

Active Comparator group

Description:

Liquid human milk fortifier to be added to human milk

Treatment:

Other: Exempt Infant Formula

Liquid Human Milk Fortifier - Standard Protein

Experimental group

Description:

Liquid human milk fortifier to be added to human milk

Treatment:

Other: Exempt Infant Formula

Liquid Human Milk Fortifier - High Protein

Experimental group

Description:

Liquid human milk fortifier to be added to human milk

Treatment:

Other: Exempt Infant Formula