NCT03618394

Brief Summary

Evaluation of changes in biochemical markers of bone metabolism. Fat profile. Evaluation of the overall body development. Assessment of parenteral nutrition protocols.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2015

Typical duration 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

April 1, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

July 25, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 7, 2018

Completed
Last Updated

August 7, 2018

Status Verified

August 1, 2018

Enrollment Period

3 years

First QC Date

July 25, 2018

Last Update Submit

August 4, 2018

Conditions

Bone Turnover Rate Disorder

Keywords

pretermsparenterallipid

Outcome Measures

Primary Outcomes (1)

  • change in plasma calcium and osteocalcin levels

    Blood sample at 1st or 2nd (within 48 hours of birth) and 20th day of life

    20 days

Secondary Outcomes (2)

  • change in plasma DHA, EPA levels

    20 days

  • cange in plasma OPG levels

    20 days

Study Arms (2)

Smoflipid

premature neonates receiving MCT/ω-3-PUFA-containing lipid emulsion

Dietary Supplement: MCT/ω-3-PUFA

Intralipid

premature neonates receiving Soybean Based lipid emulsion

Dietary Supplement: Soybean Based

Interventions

MCT/ω-3-PUFADIETARY_SUPPLEMENT

lipid emulsion

Smoflipid
Soybean BasedDIETARY_SUPPLEMENT

lipid emulsion

Intralipid

Eligibility Criteria

Age1 Day - 3 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Very Low Birth Weight preterm neonates with gestational age \<32 weeks

You may qualify if:

  • gestational age \<32 weeks
  • birth weight \<1500g (VLBW infants)
  • in need of Parenteral Nutrition support

You may not qualify if:

  • \>32 weeks of gestation
  • chromosomal or other abnormalities
  • parenteral nutrition \<80% of calorie/fluid needs
  • primary liver disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Panos Papandreou

Athens, 15123, Greece

Location

Biospecimen

Retention: SAMPLES WITH DNA

plasma

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Pharmacist, PharmD

Study Record Dates

First Submitted

July 25, 2018

First Posted

August 7, 2018

Study Start

April 1, 2015

Primary Completion

April 1, 2018

Study Completion

July 1, 2018

Last Updated

August 7, 2018

Record last verified: 2018-08

Locations

GR(1)