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Early DHA Supplementation in Very Low Birth Weight Infants

Primary Purpose

Prematurity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low dose PUFA
High dose PUFA
Placebo
Sponsored by
Mead Johnson Nutrition
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Prematurity

Eligibility Criteria

undefined - 3 Days (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rush University Medical Center
  • North Shore University Health System

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Low dose PUFA

High dose PUFA

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Red Blood Cell polyunsaturated fatty acids (PUFA) levels

Secondary Outcome Measures

Red Blood Cell PUFA levels
Feeding tolerance
Full enteral feed of 120 kcal/kg/day
Incidence of necrotizing enterocolitis
Incidence of bronchopulmonary dysplasia

Full Information

First Posted
June 19, 2017
Last Updated
May 6, 2019
Sponsor
Mead Johnson Nutrition
Collaborators
North Shore Research Institue
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1. Study Identification

Unique Protocol Identification Number
NCT03192839
Brief Title
Early DHA Supplementation in Very Low Birth Weight Infants
Official Title
Early DHA Supplementation in Very Low Birth Weight Infants
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
July 9, 2018 (Actual)
Study Completion Date
August 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mead Johnson Nutrition
Collaborators
North Shore Research Institue

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prematurity

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low dose PUFA
Arm Type
Experimental
Arm Title
High dose PUFA
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
Low dose PUFA
Intervention Description
Low dose PUFA
Intervention Type
Other
Intervention Name(s)
High dose PUFA
Intervention Description
High dose PUFA
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Red Blood Cell polyunsaturated fatty acids (PUFA) levels
Time Frame
2 weeks of age
Secondary Outcome Measure Information:
Title
Red Blood Cell PUFA levels
Time Frame
8 weeks of age
Title
Feeding tolerance
Description
Full enteral feed of 120 kcal/kg/day
Time Frame
8 weeks
Title
Incidence of necrotizing enterocolitis
Time Frame
8 weeks
Title
Incidence of bronchopulmonary dysplasia
Time Frame
8 weeks

10. Eligibility

Sex
All
Maximum Age & Unit of Time
3 Days
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy Cooper, M.D
Organizational Affiliation
Mead Johnson Nutrition
Official's Role
Study Director
Facility Information:
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
North Shore University Health System
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33358843
Citation
Frost BL, Patel AL, Robinson DT, Berseth CL, Cooper T, Caplan M. Randomized Controlled Trial of Early Docosahexaenoic Acid and Arachidonic Acid Enteral Supplementation in Very Low Birth Weight Infants. J Pediatr. 2021 May;232:23-30.e1. doi: 10.1016/j.jpeds.2020.12.037. Epub 2021 Feb 20.
Results Reference
derived

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Early DHA Supplementation in Very Low Birth Weight Infants

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