DHA Supplementation 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 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.

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Key information

Conditions

Docosohexaenoic Acid Supplementation of Mothers to Female Urogenital Diseases and Pregnancy Complications Inflammation Obstetric Labor Complications Obstetric Labor, Premature Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Premature Birth Urogenital Diseases

Age range

Up to 45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Cincinnati University Hospital Medical Center

Cincinnati, Ohio, 45229, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Expecta 200 mg

Drug

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 names: Prenatal Dietary Supplement

Expecta 1 gram

Drug

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.

Other names: Prenatal Dietary Supplement

Primary outcomes

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

Time frame: value at week 4

The study was powered to detect differences in sRAGE levels in infant serum samples at 4 weeks of age from mothers supplemented with 200 or 1000 mg/kg per day of DHA. Serum Soluble Receptor for AGE (sRAGE) levels range from 7300-100 pg/mL where the higher number means a worse outcome.

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Registry information

Official study title

Docosahexaenoic Acid Supplementation of Mothers to Improve Preterm Infant Nutrition and Immune Homeostasis

Acronym: DHA-1

Important dates

Study start: 2013
Primary completion: 2018
Study completion: 2018
First posted: Nov 26, 2012
Registry last updated: Jan 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed