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

Official title

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

Overview

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.

Detailed 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.

Interventions

• 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

Primary outcome measures

• Fatty acid levels in plasma [Time frame: Baseline to 36 weeks]
• Fatty acid levels in red blood cell (RBC) membranes [Time frame: Baseline to 36 weeks]
• Change in circulating biomarker Lipoxin A4 [Time frame: Baseline to 36 weeks]
• Change in biomarker Resolvin D1 [Time frame: Baseline to 36 weeks]
• Change in biomarker Resolvin E1 [Time frame: Baseline to 36 weeks]
• Change in Protectin/Neuroprotectin [Time frame: Baseline to 36 weeks]

Secondary outcome measures (1)

• Change in infant weigh [Time frame: Baseline to 36 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Basic science

Study locations

United States · 7 centers

• University of California, Los Angeles (UCLA) — Los Angeles
• Yale New Haven Hospital — New Haven
• Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago
• Northwestern University — Chicago
• Weill Cornell Medicine — New York
• University Health System — San Antonio
• University of Texas Health Science Center at San Antonio — San Antonio

Identifiers

NCT: NCT05380401 · HSC20220120H · 1R01HD108646

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗