Metabolic Mechanisms Induced by Enteral DHA and ARA Supplementation in Preterm Infants

Premature Clinical Trial

Official title:

Metabolic Mechanisms Induced by Enteral Docosahexaenoic Acid (DHA) and Arachidonic Acid (ARA) Supplementation in Preterm Infants

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05380401
• Other study ID #: HSC20220120H
• Secondary ID: 1R01HD108646
• Status: Recruiting
• Phase: N/A
• Start date: March 9, 2023
• Est. completion date: April 2028

Study information

• Verified date: March 2024
• Source: The University of Texas Health Science Center at San Antonio
• Contact: Cynthia Blanco, MD, MSCI-TS
• Phone: 210-567-5225
• Email: blanco[@]uthscsa.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A comprehensive analysis of the impact of exogenous enteral DHA and ARA supplementation on lipid metabolism including the production of downstream derived mediators and how this impacts important biological pathways such as metabolism, inflammation, and organogenic factors.

Description:

Infants will be randomized to receive the combined enteral DHA/ARA supplement within the first 48 hours after birth to 36 weeks postmenstrual age. The randomization procedure will follow a stratified permuted block scheme to fulfill two goals: (1) randomize infants into one of four arms and (2) ensure an adequate sample size within each week of gestational age. Preterm infants will be randomized using random permuted blocks within each of the 5 birth gestational age strata. When treatment assignment is open and sample size is not overtly large, a block randomization procedure with randomly chosen block sizes can maintain treatment assignment balance and reduce the potential for selection bias. This approach will also ensure that preterm infants of all eligible gestational ages at birth are approximately equally represented in each of 4 arms of the trial, thus ensuring that important comorbidities and standard of care applicable to infants of different gestational ages at birth are also approximately equally distributed across the study arms. There is no placebo for this study. There is no blinding in this study. Consent will also be obtained from the mother of the infant, as they will be asked to provide milk samples if they're breastfeeding their infant, and maternal medical history and demographical data will be recorded.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 328
• Est. completion date: April 2028
• Est. primary completion date: April 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 36 Weeks

Eligibility

Inclusion Criteria:

• born between 25 0/7 and 29 6/7 weeks of gestation

• less than 48 hours of age at first lipid dose (The cohort is defined by gestational age rather than birth weight to avoid an over-represented sample of growth-restricted infants in birth weight defined cohorts.)

Exclusion Criteria:

• serious congenital anomalies

• conditions at birth that will require surgery prior to discharge

• imminent death such that withdrawal of intensive care support is anticipated within the first 72 hours after birth

Related Conditions & MeSH terms

• Premature
• Premature Birth

Intervention

Dietary Supplement:
• Enfamil® DHA & ARA Supplement for Special Dietary Use
Dosage: 60 mg/kg/day of DHA and 120 mg/kg/day of ARA. Route of administration: enteral tube or by oral syringe

Locations

Country	Name	City	State
United States	Ann & Robert H. Lurie Children's Hospital of Chicago	Chicago	Illinois
United States	Northwestern University	Chicago	Illinois
United States	University of California, Los Angeles (UCLA)	Los Angeles	California
United States	Yale New Haven Hospital	New Haven	Connecticut
United States	Weill Cornell Medicine	New York	New York
United States	University Health System	San Antonio	Texas
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Bronchopulmonary dysplasia (BDP)	Percentage of participants with BDP	Baseline to 36 weeks
Other	Late-onset sepsis (LOS)	Percentage of participants with LOS	Baseline to 36 weeks
Other	Retinopathy of prematurity (ROP)	Percentage of participants with ROP	Baseline to 36 weeks
Other	Necrotizing enterocolitis (NEC)	Percentage of participants with NEC	Baseline to 36 weeks
Primary	Fatty acid levels in plasma	Change in lipid metabolites reflected by levels in plasma	Baseline to 36 weeks
Primary	Fatty acid levels in red blood cell (RBC) membranes	Change in fatty acid levels in RBC membranes	Baseline to 36 weeks
Primary	Change in circulating biomarker Lipoxin A4	Biomarker reflective of system development and function will be measured. There are no specific levels since there is no normative data in neonates.	Baseline to 36 weeks
Primary	Change in biomarker Resolvin D1	Biomarker reflective of system development and function will be measured. There are no specific levels since there is no normative data in neonates.	Baseline to 36 weeks
Primary	Change in biomarker Resolvin E1	Biomarker reflective of system development and function will be measured. There are no specific levels since there is no normative data in neonates.	Baseline to 36 weeks
Primary	Change in Protectin/Neuroprotectin	Levels of protectin/neuroprotectin and fatty acids in the n3 and n6 pathways will be measured.	Baseline to 36 weeks
Secondary	Change in infant weigh	Recorded in grams (ounces)	Baseline to 36 weeks