Early DHA Supplementation in Very Low Birth Weight Infants

Not Applicable

Completed

• Conditions: Prematurity
• Interventions: Other: Low dose PUFA; Other: Placebo; Other: High dose PUFA

• Registration Number: NCT03192839
• Lead Sponsor: Mead Johnson Nutrition

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-19
• Study First Submitted QC: 2017-06-19
• Study First Posted: 2017-06-20
• Study Start: 2017-07-01
• Primary Completion: 2018-07-09
• Study Completion: 2018-08-30
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-06
• Last Update Posted: 2019-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low dose PUFA	Low dose PUFA	-
Placebo	Placebo	-
High dose PUFA	High dose PUFA	-

Primary Outcome Measures

Name	Time	Method
Red Blood Cell polyunsaturated fatty acids (PUFA) levels	2 weeks of age

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States

North Shore University Health System; 🇺🇸 Evanston, Illinois, United States