DHA-1for Lactating Mothers
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Level/Amount of DHA in Mothers Breast Milk and Blood. |
Drug: Expecta 200 mg Drug: Expecta 1 gram |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| 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.
| Estimated Enrollment: | 20 |
| Study Start Date: | November 2012 |
| Estimated Study Completion Date: | January 2015 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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| Ages Eligible for Study: | up to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| 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 | Not yet 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, RMA (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 |
More Information
No publications provided
| Responsible Party: | Children's Hospital Medical Center, Cincinnati |
| ClinicalTrials.gov Identifier: | NCT01732874 History of Changes |
| Other Study ID Numbers: | 2012-0329 |
| Study First Received: | October 31, 2012 |
| Last Updated: | November 30, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Children's Hospital Medical Center, Cincinnati:
|
DHA Preterm infant Inflammation Growth Developement |
ClinicalTrials.gov processed this record on May 21, 2013