Overview

This trial is active, not recruiting.

Condition amount of dha in mothers breast milk and blood.
Treatments expecta 200 mg, expecta 1 gram
Phase phase 1/phase 2
Sponsor Children's Hospital Medical Center, Cincinnati
Start date November 2012
End date December 2016
Trial size 20 participants
Trial identifier NCT01732874, 2012-0329

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(Other)
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.
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.
(Other)
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.
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.

Primary Outcomes

Measure
Level/amount of DHA in mothers breast milk and blood.
time frame: change in DHA level from baseline to 8 wks.

Secondary Outcomes

Measure
Cytokines
time frame: change in DHA levels from baseline to 8 wks

Eligibility Criteria

Female participants up to 45 years old.

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

Additional Information

Official title Docosahexaenoic Acid Supplementation of Mothers to Improve Preterm Infant Nutrition and Immune Homeostasis
Principal investigator Ardythe Morrow, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Children's Hospital Medical Center, Cincinnati.