Clinical trial NCT01732874: DHA Supplementation for Lactating Mothers
Official title: Docosahexaenoic Acid Supplementation of Mothers to Improve Preterm Infant Nutrition and Immune Homeostasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Docosohexaenoic Acid Supplementation of Mothers to
Keywords: DHA
Preterm infant
Inflammation
Growth
Developement
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2012-11-26
Enrollment: 27
Sex: FEMALE
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this research study is to find out whether preterm infants are receiving enough of the essential and long chain fatty acids important for brain development and immune function. Our current intravenous (IV) fats do not contain the long chain fatty acids and different milk sources have different compositions. We would like to evaluate lactating mothers dietary intake and breastmilk level of fatty acid status by doing an analysis of their blood and breastmilk samples after they have been supplemented with a currently used fatty acid supplement (DHA- Martek Biosciences, now known as Dutch State Mines (DSM) Nutritional Lipid) The DHA supplement is available over the counter.

The information learned from this research study may benefit other mothers and babies in the future. The information could help make sure premature babies are receiving the right nutrients they need for appropriate growth and development.

Detailed description: We designed a prospective, randomized trial to test the hypotheses that DHA supplementation to human milk providers will increase DHA concentration in milk and infant blood levels; and that infants receiving milk from DHA-supplemented providers will be receiving a more appropriate enteral intake to better mimic intrauterine accretion. In addition, we hypothesize that pro-inflammatory cytokines will be reduced in the mothers and infants receiving the higher DHA diet.

Eligibility criteria: Inclusion Criteria:

•Lactating mothers at Cincinnati University Hospital with infants born at \< 29 weeks gestation.

Exclusion Criteria:

* the presence of congenital anomalies (trisomy 13, 18, 21, urethral, gastrointestinal and cardiac defects) that affect the standard course of care.
* mother's \<18 and
* mothers with known allergy to algeal source
* mothers with history of bleeding disorders or taking any other medication that may increase the risk of bleeding
* infants with bleeding disorders or receiving any other medication that may increase the risk of bleeding

Primary outcomes:
measure: Infant Serum Soluble Receptor for AGE (sRAGE) Levels at 4 Weeks From Baseline From Mothers Supplemented With 200 or 1000 mg/kg Per Day of DHA
timeFrame: value at week 4
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati University Hospital Medical Center
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Ardythe Morrow, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital Medical Center, Cincinnati
name: Henry Akinbi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Valentine CJ, Dingess KA, Kleiman J, Morrow AL, Rogers LK. A Randomized Trial of Maternal Docosahexaenoic Acid Supplementation to Reduce Inflammation in Extremely Preterm Infants. J Pediatr Gastroenterol Nutr. 2019 Sep;69(3):388-392. doi: 10.1097/MPG.0000000000002375.