DHA & ARA Supplementation for Prematurity
Recruiting in Palo Alto (17 mi)
+6 other locations
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: The University of Texas Health Science Center at San Antonio
Disqualifiers: Congenital anomalies, Surgery, Imminent death
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial information does not specify whether participants need to stop taking their current medications.
What data supports the effectiveness of the treatment Enfamil® DHA & ARA Supplement for Special Dietary Use in premature infants?
Research shows that supplementing premature infants with DHA (an important fatty acid for brain and eye development) can improve visual and mental development. Additionally, formulas containing DHA and ARA (another essential fatty acid) have been found to support growth and development in preterm infants.
12345Is DHA and ARA supplementation safe for preterm infants?
Research shows that DHA and ARA supplementation in infant formulas is generally safe for preterm infants, with studies indicating positive developmental outcomes and no significant safety concerns.
12367How is the treatment Enfamil® DHA & ARA Supplement for Special Dietary Use different from other treatments for prematurity?
Enfamil® DHA & ARA Supplement is unique because it provides a direct source of essential fatty acids, DHA and ARA, which are crucial for brain and immune system development in preterm infants. Unlike other treatments that may focus on increasing these nutrients through breast milk or formula, this supplement offers a targeted approach to address deficiencies in extremely premature infants who may not be able to consume full feedings for weeks.
128910Eligibility Criteria
This trial is for preterm infants born between 25 and just under 30 weeks of gestation, who are less than 48 hours old when they receive their first lipid dose. Infants needing surgery before discharge or anticipated to require withdrawal from intensive care within the first 72 hours, as well as those with serious congenital anomalies, cannot participate.Inclusion Criteria
My baby received their first lipid dose before they were 2 days old.
I was born between 25 and 29 weeks of pregnancy.
Exclusion Criteria
Serious congenital anomalies
Imminent death such that withdrawal of intensive care support is anticipated within the first 72 hours after birth
My newborn needs surgery before leaving the hospital.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1 week
Treatment
Infants receive DHA/ARA supplementation from within the first 48 hours after birth to 36 weeks postmenstrual age
Up to 36 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study is examining how a special dietary supplement called Enfamil® DHA & ARA affects fat metabolism in premature babies. It looks at whether these supplements influence biological processes like metabolism, inflammation response, and development of organs.
4Treatment groups
Experimental Treatment
Active Control
Group I: No supplement initially then DHA/ARA supplementExperimental Treatment1 Intervention
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"
Group II: DHA/ARA supplementExperimental Treatment1 Intervention
DHA/ARA supplement throughout the duration of the protocol, "d-on"
Group III: DHA/ARA initially then no supplementExperimental Treatment1 Intervention
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"
Group IV: No DHA/ARA supplementActive Control1 Intervention
no DHA/ARA supplement throughout the duration of the protocol, "d-off"
Enfamil® DHA & ARA Supplement for Special Dietary Use is already approved in United States, Canada for the following indications:
🇺🇸 Approved in United States as Enfamil DHA-in-sol for:
- Dietary supplement for infants and toddlers to support brain and eye development
🇨🇦 Approved in Canada as Enfamil DHA & ARA Supplement for Special Dietary Use for:
- Dietary supplement for infants and toddlers to support brain and eye development
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Yale New Haven HospitalNew Haven, CT
Ann & Robert H. Lurie Children's Hospital of ChicagoChicago, IL
Northwestern UniversityChicago, IL
University of Texas Health Science Center at San AntonioSan Antonio, TX
More Trial Locations
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Who Is Running the Clinical Trial?
The University of Texas Health Science Center at San AntonioLead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Collaborator
National Institutes of Health (NIH)Collaborator
References
Daily Enteral DHA Supplementation Alleviates Deficiency in Premature Infants. [2018]Docosahexaenoic acid (DHA) is an essential fatty acid (FA) important for health and neurodevelopment. Premature infants are at risk of DHA deficiency and circulating levels directly correlate with health outcomes. Most supplementation strategies have focused on increasing DHA content in mother's milk or infant formula. However, extremely premature infants may not reach full feedings for weeks and commercially available parenteral lipid emulsions do not contain preformed DHA, so blood levels decline rapidly after birth. Our objective was to develop a DHA supplementation strategy to overcome these barriers. This double-blind, randomized, controlled trial determined feasibility, tolerability and efficacy of daily enteral DHA supplementation (50 mg/day) in addition to standard nutrition for preterm infants (24-34 weeks gestational age) beginning in the first week of life. Blood FA levels were analyzed at baseline, full feedings and near discharge in DHA (n = 31) or placebo supplemented (n = 29) preterm infants. Term peers (n = 30) were analyzed for comparison. Preterm infants had lower baseline DHA levels (p
Growth and development of preterm infants fed infant formulas containing docosahexaenoic acid and arachidonic acid. [2013]To evaluate safety and benefits of feeding preterm infants formulas containing docosahexaenoic acid (DHA) and arachidonic acid (ARA) until 92 weeks postmenstrual age (PMA), with follow-up to 118 weeks PMA.
Effects of nutrition therapy on growth, inflammation and metabolism in immature infants: a study protocol of a double-blind randomized controlled trial (ImNuT). [2021]Current nutritional management of infants born very preterm results in significant deficiency of the essential fatty acids (FAs) arachidonic acid (ARA) and docosahexaenoic acid (DHA). The impact of this deficit on brain maturation and inflammation mediated neonatal morbidities are unknown. The aim of this study is to determine whether early supply of ARA and DHA improves brain maturation and neonatal outcomes in infants born before 29 weeks of gestation.
Long-chain fatty acids and early visual and cognitive development of preterm infants. [2013]Preterm infants fed formula supplemented with DHA were shown in two randomized, clinical trials to have improved visual acuity in the first half of infancy. In the second clinical trial, infants simultaneously supplemented with DHA and provided with a nutrient-enriched preterm formula had a higher Bayley MDI score at 12 months than controls fed preterm formula. These data are the first evidence that DHA alone can also improve performance on early tests of mental development. Because visual and behavioural development are improved by providing this single dietary compound, DHA appears to be conditionally essential for preterm infants. Nevertheless, we would like to insert a few words of caution. More information about long chain n-3 and n-6 fatty acid requirements and balance for developing human infants is needed. As formulas are designed to meet n-3 and n-6 fatty acid needs, controlled studies of biochemistry and function should continue.
DHA Supplementation Attenuates Inflammation-Associated Gene Expression in the Mammary Gland of Lactating Mothers Who Deliver Preterm. [2023]In a randomized trial of DHA supplementation to lactating mothers who delivered preterm, there were significant increases in DHA status in the mother and her infant.
Dietary Intakes of Arachidonic Acid and Docosahexaenoic Acid in Early Life - With a Special Focus on Complementary Feeding in Developing Countries. [2018]In developing countries, dietary intakes of arachidonic acid (ARA) and docosahexaenoic acid (DHA) in early life are lower than current recommended levels. This review specifically focusses on the contribution that complementary feeding makes to ARA and DHA intakes in medium- to low-income countries. The aims of the review are (1) to determine the availability of ARA and DHA food sources in developing countries, (2) to estimate the contribution of complementary feeding to dietary intakes of ARA and DHA in infants aged 6-36 months, and (3) to relate the dietary ARA and DHA intake data to key socioeconomic and health indicators.
DHA and ARA addition to infant formula: Current status and future research directions. [2021]Docosahexaenoic acid (DHA) and arachidonic acid (ARA) are present in breast milk and play important roles in early infant development. A supply of these fatty acids in infant formula (typically following breast milk as a model with ARA > DHA) is thought to be important since endogenous synthesis is insufficient to maintain tissue levels equivalent to breast-fed infants. Intervention studies assessing the impact of DHA- and ARA-supplemented formulas have resulted in numerous positive developmental outcomes (closer to breast-fed infants) including measures of specific cognition functions, visual acuity, and immune responses. A critical analysis of outcome assessment tools reveals the essentiality of selecting appropriate, focused techniques in order to provide accurate evaluation of DHA- and ARA-supplemented formulas. Future research directions should encompass in-depth assessment of specific cognitive outcomes, immune function, and disease incidence, as well as sources of experimental variability such as the status of fatty acid desaturase polymorphisms.
Effect of arachidonic and docosahexaenoic acid supplementation on respiratory outcomes and neonatal morbidities in preterm infants. [2023]Studies have suggested that supplementation with docosahexaenoic acid (DHA) to preterm infants might be associated with an increased risk of bronchopulmonary dysplasia (BPD). Our aim was to investigate the effect of enteral supplementation with arachidonic acid (ARA) and DHA on short-term respiratory outcomes and neonatal morbidities in very preterm infants.
The importance of dietary DHA and ARA in early life: a public health perspective. [2018]Although the literature on the contribution of DHA and arachidonic acid (ARA) to fundamental metabolic functions in brain, immune and cardiovascular systems is extensive, there is a lack of consensus on the need for explicit recommendations on dietary intake for both DHA and ARA during the early years of life. This review takes a public health perspective with the objective of ensuring that recommendations protect the most vulnerable children worldwide. Most studies on the effects of DHA and ARA in early life have been undertaken in high-income countries and this is reflected in policy recommendations. Although breast milk is considered the gold standard and always contains DHA and ARA, there are proposals that infant formulas, especially follow-on formulas, do not need to be supplemented with these fatty acids. Complementary foods frequently have low concentrations of ARA and DHA and this is most significant in low-income countries where availability is also limited. Recent evidence shows that in developing countries, intakes of DHA and ARA during the age period 6-36 months are low and this relates to low national income. It is concluded that a continuum of DHA and ARA intake needs to be maintained during early life, a critical period of infant growth and development. For both infant and follow-on formulas, DHA and ARA should be mandatory at levels that are equivalent to breast milk. An optional recommendation may be limited to countries that can demonstrate evidence of adequate intakes of DHA and ARA during early life.
Effect of arachidonic and docosahexaenoic acid supplementation on quality of growth in preterm infants: A secondary analysis of a randomized controlled trial. [2023]A balanced supply of arachidonic acid (ARA) and docosahexaenoic acid (DHA) may be crucial for quality of growth in preterm infants. This secondary analysis of a randomized controlled trial aimed to determine the effect of enhanced ARA and DHA supplementation on growth and body composition in infants born before 29 weeks of gestation. Furthermore, we aimed to study associations between human milk feeding, growth patterns and body composition.