Early DHA Supplementation in Very Low Birth Weight Infants


Original post, click here
This study is not yet open for participant recruitment.

See

Verified June 2017 by Mead Johnson Nutrition

Sponsor:

Collaborator:

North Shore Research Institue

Information provided by (Responsible Party):

Mead Johnson Nutrition

ClinicalTrials.gov Identifier:

NCT03192839

First received: June 19, 2017

Last updated: June 19, 2017

Last verified: June 2017

This clinical trial will evaluate the effects of giving supplements of PUFA to premature infants.

Prematurity Other: Low dose PUFA Other: High dose PUFA Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator
Primary Purpose: Other
Official Title: Early DHA Supplementation in Very Low Birth Weight Infants

Primary Outcome Measures:

  • Red Blood Cell polyunsaturated fatty acids (PUFA) levels [ Time Frame: 2 weeks of age ]

Secondary Outcome Measures:

Estimated Enrollment: 20
Anticipated Study Start Date: June 30, 2017
Estimated Study Completion Date: October 31, 2018
Estimated Primary Completion Date: October 31, 2018 (Final data collection date for primary outcome measure)
Experimental: Low dose PUFA Other: Low dose PUFA

Low dose PUFA

Experimental: High dose PUFA Other: High dose PUFA

High dose PUFA

Placebo Comparator: Placebo Other: Placebo

Placebo

Ages Eligible for Study:   up to 3 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Very low birth weight infants weighing less than 1500 grams
  • Consent signed within 72 hours of life

Exclusion Criteria:

  • Infants with know metabolic disorder
  • Infants with known congenital GI anomaly
  • Infants who are deemed to be inappropriate for enrollment per attending neonatologist

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: NCT03192839

Rush University Medical Center
Chicago, Illinois, United States, 60612
Contact: Judy Janes    800-876-0772      
Principal Investigator: Aloka Patel, M.D.         
North Shore University Health System
Evanston, Illinois, United States, 60201
Contact: Sue Wolf    847-570-2530      
Principal Investigator: Brandy Frost, MD         

Mead Johnson Nutrition

North Shore Research Institue

Study Director: Timothy Cooper, M.D Mead Johnson Nutrition

Responsible Party: Mead Johnson Nutrition
ClinicalTrials.gov Identifier: NCT03192839     History of Changes
Other Study ID Numbers: 6039
Study First Received: June 19, 2017
Last Updated: June 19, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Birth Weight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on June 20, 2017