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N/A N=60 Randomized Triple-blind Treatment

Bridging the Docosahexaenoic Acid (DHA) Gap: The Effects of Omega-3 Fatty Acid Supplementation in Premature Infants

Prematurity

Enrolled (actual)
60
Serious AEs
1.7%
Results posted
Apr 2018
Primary outcome: Primary: Days to Reach Full Enteral Feedings and Days on Study Oil. — 20.00; 16.21; 34.00; 33.71 days — p=0.07

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
DHA oil (Dietary_supplement); (MCT) Control oil (Dietary_supplement)
Age
Pediatric · 0+ yrs
Sex
All
Sponsor
Sanford Health
Primary completion
Feb 2014

Outcome Measures

OutcomeResultp-value
PRIMARY
Days to Reach Full Enteral Feedings and Days on Study Oil.
20.00; 16.21; 34.00; 33.71 0.07
PRIMARY
Feasibility and Tolerability of Daily Enteral DHA Oil - Weight Change
18.4; 18.4 0.048 sig
PRIMARY
Long Chain Polyunsaturated Fatty Acid (LCPUFA) Levels - Docosahexaenoic Acid (DHA) Levels in Whole Blood
2.91; 2.88; 2.83; 3.03; 2.87; 3.55
PRIMARY
Feasibility and Tolerability of Daily Enteral DHA Oil - Length Change
0.13; 0.12
PRIMARY
Feasibility and Tolerability of Daily Enteral DHA Oil - Head Circumference
0.10; 0.10
SECONDARY
LCPUFA Levels - Arachidonic Acid (ARA) in Whole Blood
13.21; 14.89; 14.35; 14.87; 14.31; 13.94

Summary

The purpose of this study is to understand if the "DHA gap" can be corrected by giving a daily dose of DHA oil to preterm babies. DHA is an essential omega-3 fatty acid, which means our body cannot make DHA. We have to take it in through our diet. DHA is important for normal brain and eye health and it may also decrease inflammation. This is important for premature babies because they are at a greater risk for getting diseases related to inflammation, especially in their lungs, eyes and intestines. Since DHA is so important for normal growth, you will find DHA naturally in breast milk and it is now added to infant formula. But the amount in breast milk and infant formula is about half of what your infant should expect to get in the womb (about 13-29mg per day in breast milk vs. 50-75mg per day in the womb). Very premature babies are at an even greater disadvantage because they cannot always eat very much right away and that is the only way they can get essential fatty acids in their body. This means premature babies are getting less DHA than they would in the womb and then the "DHA gap" continues for a longer period of time. This gap also comes at a time when their brain is growing most rapidly and their bodies need it the most. This trial is designed to see if giving DHA, even before the baby can take food orally, will raise his/her DHA blood levels to those of normal term babies.

Eligibility Criteria

Inclusion Criteria

  • Preterm infants between 24 and 33 6/7 weeks gestation
  • must be less than or equal to 1 week of age

Exclusion Criteria

  • infants who are considered by the medical team to be non-viable
  • infants with multiple or severe congenital anomalies such as gastroschisis, congenital chylothorax or other illnesses that do not allow a feeding tube to be placed or utilized at 7 days of age.
  • term infants: who are born to mothers with diabetes or are small for gestational age (SGA-less than the 10th% for adjusted gestational age
  • All families consented for this study will need to be able to read and write English
  • Mother must be 18 years of age or older
  • Taking Omegaven
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01908907). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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