Liquid Preterm Formula Versus Powdered Human Milk Fortifier in VLBW Infants

Randomized Study of a Liquid High-Calorie Preterm Formula Versus Powdered Human Milk Fortifier in Very-Low Birthweight Infants

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00760942

Enrollment

Registered

2008-09-26

Start date

2008-10-31

Completion date

2010-09-30

Last updated

2013-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infant, Very Low Birth Weight

Keywords

Low birth weight, neonates, premature infants, nutrition, human milk fortification, Infant

Brief summary

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.

Interventions

DIETARY_SUPPLEMENTSimilac special care 30

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

DIETARY_SUPPLEMENTSimilac human milk fortifier

Powdered human milk fortifier.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Days to 10 Weeks

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
The primary outcome will be weight gain in g/kg/d over the observation period. Body weight will be measured daily.	2 - 6 weeks

Secondary

Measure	Time frame
Hospital stay and feeding intolerance	2-6 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026