NCT01955044

Brief Summary

The purpose of this study is to determine if buccal administration of a concentrated formulation of long-chain polyunsaturated fatty acids (LCPUFA) can help to maintain docosahexaenoic acid (DHA) levels in extremely low birth weight (ELBW) infants.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2013

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

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

September 1, 2013

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

September 27, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 7, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
12 months until next milestone

Results Posted

Study results publicly available

March 29, 2016

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

September 5, 2021

Status Verified

August 1, 2021

Enrollment Period

1.6 years

First QC Date

September 27, 2013

Results QC Date

February 26, 2016

Last Update Submit

August 13, 2021

Conditions

Premature, Extremely Low Birth Weight InfantsPolyunsaturated Fatty Acid Levels

Keywords

neonatal prematurityinfant, extremely low birth weightfatty acids, polyunsaturated

Outcome Measures

Primary Outcomes (1)

  • Long-chain Polyunsaturated Fatty Acid (LCPUFA) Levels

    LCPUFA levels will be measured at 2 weeks of life in extremely low birth weight (ELBW) infants

    2 weeks of life

Secondary Outcomes (1)

  • LCPUFA Levels

    8 weeks of life

Study Arms (3)

"high" dose LCPUFA

EXPERIMENTAL

the "high" dose LCPUFA supplement is a drop that will be administered to ELBW infants.

Dietary Supplement: LCPUFA supplement

"low" dose LCPUFA

EXPERIMENTAL

the "low" dose LCPUFA supplement is a drop that will be administered to ELBW infants.

Dietary Supplement: LCPUFA supplement

placebo

PLACEBO COMPARATOR

the "placebo" is a drop that will be administered to ELBW infants.

Dietary Supplement: placebo

Interventions

LCPUFA supplementDIETARY_SUPPLEMENT
Also known as: PUFA supplement
"high" dose LCPUFA"low" dose LCPUFA
placeboDIETARY_SUPPLEMENT
placebo

Eligibility Criteria

AgeUp to 72 Hours
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • a) Premature infant born at gestational age less than 34 weeks
  • b) Birth weight less than 1000 grams
  • c) Legally authorized representative is able to provide written informed consent within the first 72 hours of life, prior to the performance of an protocol-specified evaluations or procedures

You may not qualify if:

  • a) infants with known metabolic disorder
  • b) infants with known congenital gastrointestinal anomaly
  • c) infants who are deemed to be inappropriate for enrollment per attending neonatologist

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

Location

Prentice Women's Hospital

Chicago, Illinois, 60611, United States

Location

NorthShore University HealthSystem

Evanston, Illinois, 60201, United States

Location

Related Publications (1)

  • Robinson DT, Caplan M, Carlson SE, Yoder R, Murthy K, Frost B. Early docosahexaenoic and arachidonic acid supplementation in extremely-low-birth-weight infants. Pediatr Res. 2016 Oct;80(4):505-10. doi: 10.1038/pr.2016.118. Epub 2016 Jun 3.

    PMID: 27356083DERIVED

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

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

Results Point of Contact

Title
Brandy L Frost
Organization
NorthShore University HealthSystem
bfrost@northshore.org
847-570-2033

Study Officials

  • Michael S Caplan, MD

    Endeavor Health

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Neonatologist, Clinician Educator

Study Record Dates

First Submitted

September 27, 2013

First Posted

October 7, 2013

Study Start

September 1, 2013

Primary Completion

April 1, 2015

Study Completion

April 1, 2016

Last Updated

September 5, 2021

Results First Posted

March 29, 2016

Record last verified: 2021-08

Locations

US(3)