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Early DHA Supplementation in Very Low Birth Weight Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03192839
Recruitment Status : Completed
First Posted : June 20, 2017
Last Update Posted : May 7, 2019
Sponsor:
Collaborator:
North Shore Research Institue
Information provided by (Responsible Party):
Mead Johnson Nutrition

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

Condition or disease Intervention/treatment Phase
Prematurity Other: Low dose PUFA Other: High dose PUFA Other: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Other
Official Title: Early DHA Supplementation in Very Low Birth Weight Infants
Actual Study Start Date : July 1, 2017
Actual Primary Completion Date : July 9, 2018
Actual Study Completion Date : August 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Weight

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Red Blood Cell polyunsaturated fatty acids (PUFA) levels [ Time Frame: 2 weeks of age ]

Secondary Outcome Measures :
  1. Red Blood Cell PUFA levels [ Time Frame: 8 weeks of age ]
  2. Feeding tolerance [ Time Frame: 8 weeks ]
    Full enteral feed of 120 kcal/kg/day

  3. Incidence of necrotizing enterocolitis [ Time Frame: 8 weeks ]
  4. Incidence of bronchopulmonary dysplasia [ Time Frame: 8 weeks ]


Information from the National Library of Medicine

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03192839


Locations
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United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
North Shore University Health System
Evanston, Illinois, United States, 60201
Sponsors and Collaborators
Mead Johnson Nutrition
North Shore Research Institue
Investigators
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Study Director: Timothy Cooper, M.D Mead Johnson Nutrition

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Responsible Party: Mead Johnson Nutrition
ClinicalTrials.gov Identifier: NCT03192839     History of Changes
Other Study ID Numbers: 6039
First Posted: June 20, 2017    Key Record Dates
Last Update Posted: May 7, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

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