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NCT03192839 Clinical Trial

Early DHA Supplementation in Very Low Birth Weight Infants

Prematurity Clinical Trial

Official title:
Early DHA Supplementation in Very Low Birth Weight Infants

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03192839
Other study ID # 6039
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 1, 2017
Est. completion date August 30, 2018

Study information
Verified date May 2019
Source Mead Johnson Nutrition
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date August 30, 2018
Est. primary completion date July 9, 2018
Accepts healthy volunteers No
Gender All
Age group N/A to 3 Days
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• Low dose PUFA
Low dose PUFA
• High dose PUFA
High dose PUFA
• Placebo
Placebo

Locations
Country Name City State
United States Rush University Medical Center Chicago Illinois
United States North Shore University Health System Evanston Illinois

Sponsors (2)
Lead Sponsor Collaborator
Mead Johnson Nutrition North Shore Research Institue

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Red Blood Cell polyunsaturated fatty acids (PUFA) levels 2 weeks of age
Secondary Red Blood Cell PUFA levels 8 weeks of age
Secondary Feeding tolerance Full enteral feed of 120 kcal/kg/day 8 weeks
Secondary Incidence of necrotizing enterocolitis 8 weeks
Secondary Incidence of bronchopulmonary dysplasia 8 weeks
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