NCT00760942

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 24, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 26, 2008

Completed
5 days until next milestone

Study Start

First participant enrolled

October 1, 2008

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

December 10, 2013

Status Verified

December 1, 2013

Enrollment Period

1.4 years

First QC Date

September 24, 2008

Last Update Submit

December 9, 2013

Conditions

Infant, Very Low Birth Weight

Keywords

Low birth weightneonatespremature infantsnutritionhuman milk fortificationInfant

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Hospital stay and feeding intolerance

    2-6 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

Liquid human milk fortifier

Dietary Supplement: Similac special care 30

2

ACTIVE COMPARATOR

Powdered human milk fortifier

Dietary Supplement: Similac human milk fortifier

Interventions

Similac special care 30DIETARY_SUPPLEMENT

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

1
Similac human milk fortifierDIETARY_SUPPLEMENT

Powdered human milk fortifier.

2

Eligibility Criteria

Age1 Day - 10 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • Infants with major congenital anomalies and previous history of gastrointestinal disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neonatal Intensive Care Unit/Children's Hospital

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Andrea Willeitner, M.D.

    University of Oklahoma

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2008

First Posted

September 26, 2008

Study Start

October 1, 2008

Primary Completion

March 1, 2010

Study Completion

September 1, 2010

Last Updated

December 10, 2013

Record last verified: 2013-12

Locations

US(1)