NCT00601081

Brief Summary

This is a research study investigating if adding human milk fortifier to a preterm babies breast milk feedings affects the baby's immune system.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2007

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2008

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 25, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

May 10, 2017

Status Verified

May 1, 2017

Enrollment Period

7 months

First QC Date

January 15, 2008

Last Update Submit

May 9, 2017

Conditions

Infant, Very Low Birth Weight

Keywords

Very low birth weight infantsHMFimmune system function

Outcome Measures

Primary Outcomes (1)

  • Cytokine profile pre and post initiation of HMF

    up to 14 days

Study Arms (1)

1

Very low birth weight and preterm infants who will likely receive fortification of breast milk with HMF

Eligibility Criteria

AgeUp to 6 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Infants hospitalized in the newborn intensive care unit.

You may qualify if:

  • Infants born weighing less than 1500 grams
  • exclusive breast milk feedings with intention to fortify with human milk fortifier

You may not qualify if:

  • positive blood culture
  • history of necrotizing enterocolitis
  • significant lung disease at the start of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Christiana Hospital

Newark, Delaware, 19718, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood and stool

Study Officials

  • Robert G. Locke, DO

    Christiana Hospital

    PRINCIPAL INVESTIGATOR

  • Christopher T. Hsu, MD

    Christiana Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2008

First Posted

January 25, 2008

Study Start

November 1, 2007

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

May 10, 2017

Record last verified: 2017-05

Locations

US(1)