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

The University of Texas System (UT)

Status: Enrolling

Conditions: Premature

Treatments: Dietary Supplement: Enfamil® DHA & ARA Supplement for Special Dietary Use

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05380401

HSC20220120H

1R01HD108646 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 328 estimated patients

Sex: All

Ages: Under 36 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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328 participants in 4 patient groups

DHA/ARA supplement

Other group

Description:

DHA/ARA supplement throughout the duration of the protocol, "d-on"

Treatment:

Dietary Supplement: Enfamil® DHA & ARA Supplement for Special Dietary Use

No DHA/ARA supplement

No Intervention group

Description:

no DHA/ARA supplement throughout the duration of the protocol, "d-off"

DHA/ARA initially then no supplement

Other group

Description:

DHA/ARA supplement from enrollment to 31 6/7 weeks post-menstrual age (PMA) then no supplement from 32 to 36 weeks' PMA, "x- on/off"

Treatment:

Dietary Supplement: Enfamil® DHA & ARA Supplement for Special Dietary Use

No supplement initially then DHA/ARA supplement

Other group

Description:

No DHA/ARA supplement till 31 6/7 weeks' then long-chain polyunsaturated fatty acids (LCPUFA) supplement from 32 to 36 weeks PMA, "x-off/on"

Treatment:

Dietary Supplement: Enfamil® DHA & ARA Supplement for Special Dietary Use