Human Milk Fortifier

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

COMPLETED

Clinical Phase

NA

Total Enrollment

186 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2015-03-31

Brief Summary

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It it is hypothesized that the growth of preterm infants receiving a new human milk fortifier will be equal or superior to the growth of preterm infants receiving a currently marketed human milk fortifier with a lower protein content.

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Detailed Description

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Conditions

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Premature Birth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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New human milk fortifier

Group Type EXPERIMENTAL

Intervention Type DIETARY_SUPPLEMENT

Currently marketed fortifier

Group Type ACTIVE_COMPARATOR

Human milk fortifier

Intervention Type DIETARY_SUPPLEMENT

New human milk fortifier with new Ca source

a subgroup of patients will receive the new milk fortifier containing a new source of calcium.

Group Type EXPERIMENTAL

Human milk fortifier

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Human milk fortifier

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Birth weight ≤1500 g AND/OR gestational age ≤32 weeks (determined by maternal dates, fetal ultrasound, Dubowitz/Ballard examination or a combination thereof)
* Male or female
* Tolerating an enteral intake of human milk, donor milk or a combination at ≥100 mL/kg/d for ≥ 24 h
* Subject is anticipated to receive human milk, donor milk or a combination for ≥ 3 consecutive weeks after having achieved full fortification with volume intake contained between 150 and 180 mL/kg/d.
* Written informed consent has been obtained from the legal representative(s).

Exclusion Criteria

* Infants with current systemic disease
* Infants with a history of systemic disease
* Any congenital anomalies of the GI tract that significantly interfere with nutrition and growth or previous GI surgery.
* Small size for gestational age (SGA) - body weight ≦ 5th percentile for that gestational age.
* Infants diagnosed with any inherent metabolic disease.
* Infants diagnosed with any chromosomic disease.
* Receiving any commercial formula supplementation to breast milk.
* Receiving steroids at the time of enrollment.
* Participation in another nutritional clinical trial that may affect outcomes of this study.

Maximum Eligible Age

1 Month

Eligible Sex

ALL

Accepts Healthy Volunteers

No