Early DHA Supplementation in Very Low Birth Weight Infants

NCT ID: NCT03192839

Last Updated: 2019-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-01

Study Completion Date

2018-08-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Prematurity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Low dose PUFA

Group Type EXPERIMENTAL

Low dose PUFA

Intervention Type OTHER

Low dose PUFA

High dose PUFA

Group Type EXPERIMENTAL

High dose PUFA

Intervention Type OTHER

High dose PUFA

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Low dose PUFA

Low dose PUFA

Intervention Type OTHER

High dose PUFA

High dose PUFA

Intervention Type OTHER

Placebo

Placebo

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Maximum Eligible Age

3 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

North Shore Research Institue

UNKNOWN

Sponsor Role collaborator

Mead Johnson Nutrition

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Timothy Cooper, M.D

Role: STUDY_DIRECTOR

Mead Johnson Nutrition

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Rush University Medical Center

Chicago, Illinois, United States

Site Status

North Shore University Health System

Evanston, Illinois, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 33358843 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

6039

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

DHA Supplementation for Lactating Mothers
NCT01732874 COMPLETED PHASE1/PHASE2
Omega Tots Long Term Follow-up
NCT05191823 ENROLLING_BY_INVITATION NA