Feeding Study in VLBW Premature Infants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-10

Study Completion Date

2024-05-31

Brief Summary

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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

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Detailed Description

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Conditions

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VLBW - Very Low Birth Weight Infant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Commercial Liquid Human Milk Fortifier

Liquid human milk fortifier to be added to human milk

Group Type ACTIVE_COMPARATOR

Exempt Infant Formula

Intervention Type OTHER

Liquid human milk fortifier to be added to human milk daily

Liquid Human Milk Fortifier - Standard Protein

Liquid human milk fortifier to be added to human milk

Group Type EXPERIMENTAL

Exempt Infant Formula

Intervention Type OTHER

Liquid human milk fortifier to be added to human milk daily

Liquid Human Milk Fortifier - High Protein

Liquid human milk fortifier to be added to human milk

Group Type EXPERIMENTAL

Exempt Infant Formula

Intervention Type OTHER

Liquid human milk fortifier to be added to human milk daily

Interventions

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Exempt Infant Formula

Liquid human milk fortifier to be added to human milk daily

Intervention Type OTHER

Eligibility Criteria

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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)

Minimum Eligible Age

168 Days

Maximum Eligible Age

224 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No