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Liquid Preterm Formula Versus Powdered Human Milk Fortifier in VLBW Infants

NCT ID: NCT00760942

Last Updated: 2013-12-10

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

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2010-09-30

Brief Summary

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This study aims to compare the short-term effects on growth and feeding tolerance of a liquid high calorie formula added to human milk versus powdered human milk fortifier in small preterm infants.

Detailed Description

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Conditions

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Infant, Very Low Birth Weight

Keywords

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Low birth weight neonates premature infants nutrition human milk fortification Infant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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1

Liquid human milk fortifier

Group Type ACTIVE_COMPARATOR

Similac special care 30

Intervention Type DIETARY_SUPPLEMENT

Liquid pre-term formula 30Kcals/oz. used as human milk fortifier.

2

Powdered human milk fortifier

Group Type ACTIVE_COMPARATOR

Similac human milk fortifier

Intervention Type DIETARY_SUPPLEMENT

Powdered human milk fortifier.

Interventions

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Similac special care 30

Liquid pre-term formula 30Kcals/oz. used as human milk fortifier.

Intervention Type DIETARY_SUPPLEMENT

Similac human milk fortifier

Powdered human milk fortifier.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Infants between 500 and 1499 grams of birthweight, receiving mother's milk.

Exclusion Criteria

* Infants with major congenital anomalies and previous history of gastrointestinal disease.
Minimum Eligible Age

1 Day

Maximum Eligible Age

10 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Oklahoma

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andrea Willeitner, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Oklahoma

Locations

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Neonatal Intensive Care Unit/Children's Hospital

Oklahoma City, Oklahoma, United States

Site Status

Countries

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United States

Other Identifiers

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14132

Identifier Type: -

Identifier Source: org_study_id