NCT03192839

Brief Summary

This clinical trial will evaluate the effects of giving supplements of PUFA to premature 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 Jul 2017

Geographic Reach
1 country

2 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

First Submitted

Initial submission to the registry

June 19, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 20, 2017

Completed
11 days until next milestone

Study Start

First participant enrolled

July 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 9, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2018

Completed
Last Updated

May 7, 2019

Status Verified

May 1, 2019

Enrollment Period

1 year

First QC Date

June 19, 2017

Last Update Submit

May 6, 2019

Conditions

Prematurity

Outcome Measures

Primary Outcomes (1)

  • Red Blood Cell polyunsaturated fatty acids (PUFA) levels

    2 weeks of age

Secondary Outcomes (4)

  • Red Blood Cell PUFA levels

    8 weeks of age

  • Feeding tolerance

    8 weeks

  • Incidence of necrotizing enterocolitis

    8 weeks

  • Incidence of bronchopulmonary dysplasia

    8 weeks

Study Arms (3)

Low dose PUFA

EXPERIMENTAL
Other: Low dose PUFA

High dose PUFA

EXPERIMENTAL
Other: High dose PUFA

Placebo

PLACEBO COMPARATOR
Other: Placebo

Interventions

Low dose PUFAOTHER

Low dose PUFA

Low dose PUFA
High dose PUFAOTHER

High dose PUFA

High dose PUFA
PlaceboOTHER

Placebo

Placebo

Eligibility Criteria

AgeUp to 3 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

North Shore University Health System

Evanston, Illinois, 60201, United States

Location

Related Publications (1)

  • 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.

    PMID: 33358843DERIVED

MeSH Terms

Conditions

Premature Birth

Interventions

Fatty Acids, Unsaturated

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Fatty AcidsLipids

Study Officials

  • Timothy Cooper, M.D

    Mead Johnson Nutrition

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2017

First Posted

June 20, 2017

Study Start

July 1, 2017

Primary Completion

July 9, 2018

Study Completion

August 30, 2018

Last Updated

May 7, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

US(2)