DHA-1 for Lactating Mothers
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 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.
Level/Amount of DHA in Mothers Breast Milk and Blood.
Drug: Expecta 200 mg
Drug: Expecta 1 gram
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||Docosahexaenoic Acid Supplementation of Mothers to Improve Preterm Infant Nutrition and Immune Homeostasis|
- Level/amount of DHA in mothers breast milk and blood. [ Time Frame: change in DHA level from baseline to 8 wks. ] [ Designated as safety issue: No ]The objective of this project is to improve preterm infant intake of DHA that approximate the levels obtained by fetal accretion during the third trimester of pregnancy and determine if there are functional relationships to inflammation, growth, and development
- Cytokines [ Time Frame: change in DHA levels from baseline to 8 wks ] [ Designated as safety issue: No ]Higher intakes of dietary DHA will decrease expression of pro-inflammatory cytokines and increase expression of anti-inflammatory cytokines in the plasma and milk samples of breast feeding mother - infant dyads through the alteration of sRAGE signaling.
|Study Start Date:||November 2012|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Expecta 200 mg
Breastfeeding mothers of pre-mature infants randomly assigned to 200 mg Expecta to be taken orally once a day. Expecta to be taken for approximately 8 weeks post-partum or a shorter time if infant is discharged sooner from NICU.
Drug: Expecta 200 mg
Breastfeeding mothers who have given birth to premature infant 29 weeks or less will be randomized to receive 200mg Expecta. They will take once a day for 8 weeks or a shorter time if infant is discharged sooner from NICU.
Expecta 1 Gram
Breastfeeding mothers of pre-mature infants randomly assigned to one Gram of Expecta to be taken orally once a day. Expecta to be taken for approximately 8 weeks post-partum or a shorter time if infant is discharged sooner from NICU.
Drug: Expecta 1 gram
Breastfeeding mothers who have given birth to premature infant 29 weeks or less will be randomized to receive 1 gram of Expecta. They will take once a day for 8 weeks or a shorter time if infant is discharged sooner from NICU.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01732874
|Contact: Christina Valentine, MD, MS, RD||(513) 636-9902||Christina.Valentine@cchmc.org|
|Contact: Jeanne Kleiman, BS, CLC, ALC||(513) 636-9719||Jeanne.Kleiman@cchmc.org|
|United States, Ohio|
|Cincinnati University Hospital Medical Center||Recruiting|
|Cincinnati, Ohio, United States, 45229|
|Contact: Christina Valentine, MD, MS, RD (513) 636-9902 Christina.Valentine@cchmc.org|
|Contact: Jeanne Kleiman, BS, CLC, ALC, CCRP (513) 636-9719 Jeanne.Kleiman@cchmc.org|
|Principal Investigator: Christina Valentine, MD,MS,RD|
|Principal Investigator:||Christina Valentine, MD,MS, RD||Cincinnati Children's Hosptial Medical Center|