Clinical trial NCT01908907: Bridging the Docosahexaenoic Acid (DHA) Gap: The Effects of Omega-3 Fatty Acid Supplementation in Premature Infants
Official title: Bridging the Docosahexaenoic Acid (DHA) Gap: The Effects of Omega-3 Fatty Acid Supplementation in Premature Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prematurity
Keywords: Premature Infants
DHA(docosahexaenoic acid)
DHA deficit
Lead sponsor: Sanford Health
Sponsor class: OTHER
Collaborators: name: The Gerber Foundation
First posted: 2013-07-26
Enrollment: 60
Sex: ALL
Minimum age (years): 24
Maximum age (years): 33
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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 is to develop a DHA supplementation strategy to overcome these barriers. This single-center, 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 will be analyzed at baseline, full feedings and near discharge in DHA or placebo supplemented preterm infants. Term peers will also have blood FA levels analyzed for comparison. Growth, feeding tolerance and adverse outcomes (NEC, intraventricular hemorrhage (IVH), thrombocytopenia, sepsis) will be evaluated. Study progress and safety will be monitored by an external Data Safety Monitoring Board (DSMB). Overall, the study aims to determine if daily enteral DHA supplementation is feasible and alleviates deficiency in premature infants.

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

Primary outcomes:
measure: Days to Reach Full Enteral Feedings and Days on Study Oil.
timeFrame: From enrollment until the infant reaches full feed or is discharged from the NICU, whichever comes first, assessed up to 50 days.
measure: Feasibility and Tolerability of Daily Enteral DHA Oil - Weight Change
timeFrame: 30 days from birth
measure: Long Chain Polyunsaturated Fatty Acid (LCPUFA) Levels - Docosahexaenoic Acid (DHA) Levels in Whole Blood
timeFrame: At baseline (enrollment, < 1 week of age), full feedings, discharge
measure: Feasibility and Tolerability of Daily Enteral DHA Oil - Length Change
timeFrame: 30 days from birth
measure: Feasibility and Tolerability of Daily Enteral DHA Oil - Head Circumference
timeFrame: 30 days from birth
Secondary outcomes:
measure: LCPUFA Levels - Arachidonic Acid (ARA) in Whole Blood
timeFrame: At baseline (enrollment, <1 week of age), full feedings and discharge
Other outcomes:
measure: LCPUFA Levels - Alpha-linolenic Acid (ALA) in Whole Blood
timeFrame: Baseline (<1 week of age), full enteral feedings and discharge
measure: LCPUFA Levels - Linoleic Acid (LNA)
timeFrame: Baseline, full feedings and discharge
Locations:
city: Sioux Falls
country: United States
facility: Sanford Health USD
state: South Dakota
Study officials:
affiliation: Sanford Health
name: Michelle L Baack, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Baack ML, Puumala SE, Messier SE, Pritchett DK, Harris WS. Daily Enteral DHA Supplementation Alleviates Deficiency in Premature Infants. Lipids. 2016 Apr;51(4):423-33. doi: 10.1007/s11745-016-4130-4. Epub 2016 Feb 4.
citation: Baack ML, Puumala SE, Messier SE, Pritchett DK, Harris WS. What is the relationship between gestational age and docosahexaenoic acid (DHA) and arachidonic acid (ARA) levels? Prostaglandins Leukot Essent Fatty Acids. 2015 Sep;100:5-11. doi: 10.1016/j.plefa.2015.05.003. Epub 2015 Jun 17.