Early DHA Supplementation in Very Low Birth Weight Infants

Mead Johnson Nutrition

Status: Completed

Conditions: Prematurity

Treatments: Other: Placebo; Other: High dose PUFA; Other: Low dose PUFA

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT03192839

6039

Details and patient eligibility

About

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

Enrollment: 30 patients

Sex: All

Ages: Under 3 days old

Volunteers: No 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 3 patient groups, including a placebo group

Low dose PUFA

Experimental group

Treatment:

Other: Low dose PUFA

High dose PUFA

Experimental group

Treatment:

Other: High dose PUFA

Placebo

Placebo Comparator group

Treatment:

Other: Placebo