Trial record 15 of 103 for:    Open Studies | "Infant, Low Birth Weight"

PUFA Supplementation in Premature Infants

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by NorthShore University HealthSystem Research Institute
Sponsor:
Collaborators:
Ann & Robert H Lurie Children's Hospital of Chicago
Feinberg School of Medicine, Northwestern University
Mead Johnson Nutrition
Information provided by (Responsible Party):
Brandy Frost, NorthShore University HealthSystem Research Institute
ClinicalTrials.gov Identifier:
NCT01955044
First received: September 27, 2013
Last updated: January 8, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Premature, Extremely Low Birth Weight Infants
Polyunsaturated Fatty Acid Levels
Dietary Supplement: LCPUFA supplement
Dietary Supplement: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Early DHA Supplementation in Extremely Low Birth Weight Infants

Resource links provided by NLM:


Further study details as provided by NorthShore University HealthSystem Research Institute:

Primary Outcome Measures:
  • long-chain polyunsaturated fatty acid (LCPUFA) levels [ Time Frame: 2 weeks of life ] [ Designated as safety issue: No ]
    LCPUFA levels will be measured at 2 weeks of life.


Secondary Outcome Measures:
  • LCPUFA levels [ Time Frame: 8 weeks of life ] [ Designated as safety issue: No ]
    LCPUFA levels will be measured at 8 weeks of life.

  • resolvin levels [ Time Frame: 8 weeks of life ] [ Designated as safety issue: No ]
    Resolvin, a metabolite of LCPUFA, will be measured at 8 weeks of life.

  • resolvin levels [ Time Frame: 2 weeks of life ] [ Designated as safety issue: No ]
    resolvin, a metabolite of LCPUFA, will be measured at 2 weeks of life.


Estimated Enrollment: 30
Study Start Date: September 2013
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: "high" dose LCPUFA
the "high" dose LCPUFA supplement is a drop that will be administered to ELBW infants.
Dietary Supplement: LCPUFA supplement
Other Name: PUFA supplement
Experimental: "low" dose LCPUFA
the "low" dose LCPUFA supplement is a drop that will be administered to ELBW infants.
Dietary Supplement: LCPUFA supplement
Other Name: PUFA supplement
Placebo Comparator: placebo
the "placebo" is a drop that will be administered to ELBW infants.
Dietary Supplement: placebo

Detailed Description:

This will be a multi-center, randomized, placebo controlled, double blind trial.

Two doses of PUFA will be compared to placebo- a "high" dose and a "low" dose.

ELBW infants will be enrolled into this study.

  Eligibility

Ages Eligible for Study:   up to 72 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01955044

Contacts
Contact: Brandy L Frost, MD 847-570-2033 bfrost@northshore.org
Contact: Michael S Caplan, MD 847-570-2530

Locations
United States, Illinois
Lurie Children's Hospital of Chicago Recruiting
Chicago, Illinois, United States, 60611
Contact: Daniel T Robinson, MD    312-227-4190    dtrobinson@luriechildrens.org   
Principal Investigator: Daniel T Robinson, MD         
Prentice Women's Hospital Recruiting
Chicago, Illinois, United States, 60611
Contact: Daniel T Robinson, MD    312-227-4190      
Principal Investigator: Daniel T Robinson, MD         
NorthShore University HealthSystem Recruiting
Evanston, Illinois, United States, 60201
Contact: Brandy L Frost, MD    847-570-2033    bfrost@northshore.org   
Principal Investigator: Brandy L Frost, MD         
Sponsors and Collaborators
NorthShore University HealthSystem Research Institute
Ann & Robert H Lurie Children's Hospital of Chicago
Feinberg School of Medicine, Northwestern University
Mead Johnson Nutrition
Investigators
Principal Investigator: Michael S Caplan, MD NorthShore University HealthSystem
  More Information

No publications provided

Responsible Party: Brandy Frost, Attending Neonatologist, Clinician Educator, NorthShore University HealthSystem Research Institute
ClinicalTrials.gov Identifier: NCT01955044     History of Changes
Other Study ID Numbers: MJN 8662
Study First Received: September 27, 2013
Last Updated: January 8, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by NorthShore University HealthSystem Research Institute:
neonatal prematurity
infant, extremely low birth weight
fatty acids, polyunsaturated

Additional relevant MeSH terms:
Birth Weight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014