Preterm Infant Growth

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

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2014-09-30

Brief Summary

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The purpose of this study is to assess growth of preterm infants fed a test formula compared to a standard formula up to the first 4 months of corrected gestational age.

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Detailed Description

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Conditions

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Growth Development Infant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Control

commercially available formula

Group Type ACTIVE_COMPARATOR

control infant formula

Intervention Type OTHER

commercially available infant formula

Test

test formula

Group Type EXPERIMENTAL

infant formula

Intervention Type OTHER

test infant formula fed to infants until 6 months corrected gestational age

Interventions

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infant formula

test infant formula fed to infants until 6 months corrected gestational age

Intervention Type OTHER

control infant formula

commercially available infant formula

Intervention Type OTHER

Other Intervention Names

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test infant formula commercially available infant formula fed to infants until 6 months corrected gestational age

Eligibility Criteria

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Inclusion Criteria

* Born AGA
* Exclusively formula-fed
* 28-34 weeks GA at birth
* Intact GI tract, tolerating full oral feeds
* Expected to be discharged from the hospital within a minimum of 24 hours, maximum of 5 days

Exclusion Criteria

* Severe respiratory disease defined as needing mechanical ventilation at discharge
* Any significant systemic diseases that could affect growth. This includes cardiac, neurologic, or GI conditions.
* Major congenital malformation, history of GI surgery, severe postnatal complications
* Daily or routine diuretic use at time of discharge
* Receiving more than 10% of daily kcals from food additives such as thickeners
* Currently participating or having participated in another conflicting clinical trial.

Maximum Eligible Age

1 Month

Eligible Sex

ALL

Accepts Healthy Volunteers

No