Early DHA Supplementation in Very Low Birth Weight Infants | NCT03192839

Studies
Early DHA Supplementation in Very Low Birth Weight Infants

NCT03192839

Sponsor

Mead Johnson Nutrition

Status

Completed

Last Update Posted

May 7, 2019Actual

Enrollment

30Actual

Phase

Not Applicable

Conditions

Prematurity

Interventions

Low dose PUFA
High dose PUFA
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2017Actual

Primary Completion Date

Jul 9, 2018Actual

Completion Date

Aug 30, 2018Actual

First Submitted Date

Jun 19, 2017

First Submission Date that Met QC Criteria

Jun 19, 2017

First Posted Date

Jun 20, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 6, 2019

Last Update Posted Date

May 7, 2019Actual

Name	Class
North Shore Research Institue	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Low dose PUFA	Experimental	Other: Low dose PUFA
High dose PUFA	Experimental	Other: High dose PUFA
Placebo	Placebo Comparator	Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Low dose PUFA	Other	Low dose PUFA	Low dose PUFA
High dose PUFA

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Red Blood Cell polyunsaturated fatty acids (PUFA) levels		2 weeks of age

Secondary Outcomes

Measure	Description	Time Frame
Red Blood Cell PUFA levels		8 weeks of age
Feeding tolerance	Full enteral feed of 120 kcal/kg/day	8 weeks

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

3 Days

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Timothy Cooper, M.D	Mead Johnson Nutrition	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rush University Medical Center		Chicago	Illinois	60612	United States
North Shore University Health System

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33358843	Derived	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.

ID	Term
D007752	Obstetric Labor, Premature
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications

ID	Term
D005227	Fatty Acids
D008055	Lipids