Early DHA Supplementation in Very Low Birth Weight Infants

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03192839

Enrollment

Registered

2017-06-20

Start date

2017-07-01

Completion date

2018-08-30

Last updated

2019-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prematurity

Brief summary

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

Interventions

OTHERLow dose PUFA

Low dose PUFA

OTHERHigh dose PUFA

High dose PUFA

OTHERPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

No minimum to 3 Days

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Incidence of bronchopulmonary dysplasia	8 weeks	—
Red Blood Cell PUFA levels	8 weeks of age	—
Feeding tolerance	8 weeks	Full enteral feed of 120 kcal/kg/day
Incidence of necrotizing enterocolitis	8 weeks	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026