A Phase 1/2 interventional study of Expecta 200 mg and Expecta 1 gram in Docosohexaenoic Acid Supplementation of Mothers to, sponsored by Children's Hospital Medical Center, Cincinnati. Completed at 1 site in United States. Open to female participants aged Up to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-01-05.
Sponsored by Children's Hospital Medical Center, Cincinnati · Phase 1/2, Interventional, and Basic science
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.
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.
Children's Hospital Medical Center, Cincinnati is the lead sponsor of 661 studies on the registry; 134 are open to participants now.
Of its 54 completed or terminated interventional studies of FDA-regulated products, 30 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
•Lactating mothers at Cincinnati University Hospital with infants born at \< 29 weeks gestation.
Exclusion Criteria:
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 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 200mg Expecta. They will take once a day for 8 weeks or a shorter time if infant is discharged sooner from NICU.
Also known as: Prenatal Dietary Supplement
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.
Also known as: Prenatal Dietary Supplement
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
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.
Time frame: value at week 4
Mothers recruited at The University of Cincinnati with pregnancy \< 28 weeks and no congenital anomalies
| Milestone | Expecta 200 mg | Expecta 1 Gram |
|---|---|---|
| Started | 16 | 11 |
| Completed | 8 | 8 |
| Not completed | 8 | 3 |
| Withdrew: Withdrawal by subject | 5 | 1 |
| Withdrew: Death of infant | 3 | 2 |
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.
| pg/mL | Expecta 200 mg | Expecta 1 Gram |
|---|---|---|
| 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 | 900 (218 to 1650) | 1127 (256 to 2050) |
Collected over baseline to 4 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Expecta 200 mg | 0/16 (0%) | 0/16 (0%) | 0/16 (0%) |
| Expecta 1 Gram | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) |
Lactating mothers at Cincinnati University Hospital with infants born at \< 29 weeks gestation admitted to The Cincinnati University Hospital NICU
| Age, Categorical(Participants) | Expecta 200 mg | Expecta 1 Gram | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 16 | 11 | 27 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Expecta 200 mg | Expecta 1 Gram | Total |
|---|---|---|---|
| Female | 16 | 11 | 27 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Expecta 200 mg | Expecta 1 Gram | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 0 | 1 |
| Not Hispanic or Latino | 15 | 11 | 26 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Expecta 200 mg | Expecta 1 Gram | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 3 | 4 | 7 |
| White | 10 | 6 | 16 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 3 | 1 | 4 |
| Baseline Infant Serum Soluble Receptor for AGE (sRAGE) levels(pg/ml) | Expecta 200 mg | Expecta 1 Gram | Total |
|---|---|---|---|
| Median | 746 (428 to 2201) | 5336 (416 to 7270) | 3041 (416 to 7270) |
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Children's Hospital Medical Center, Cincinnati