DHA Supplementation for Lactating Mothers (DHA-1)

Cincinnati Children's Hospital Medical Center

Status and phase: Completed; Phase 2; Phase 1

Conditions: Docosohexaenoic Acid Supplementation of Mothers to

Treatments: Drug: Expecta 1 gram; Drug: Expecta 200 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT01732874

2012-0329

Details and patient eligibility

About

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.

Full 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.

Enrollment: 27 patients

Sex: Female

Ages: Under 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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27 participants in 2 patient groups

Expecta 200 mg

Other group

Description:

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.

Treatment:

Drug: Expecta 200 mg

Expecta 1 Gram

Other group

Description:

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.

Treatment:

Drug: Expecta 1 gram