Preterm Delivery Clinical Trial
— MERMAIDOfficial title:
A Randomized, Double-blind, Placebo-controlled, Multicenter Trial Exploring the Efficacy and Safety of Intra-nasal Administration of Merotocin in Increasing Milk Production in Maternal Subjects With Preterm Delivery and Inadequate Milk Production
Verified date | November 2022 |
Source | Ferring Pharmaceuticals |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Induction and support of lactation in women with preterm delivery and inadequate milk production.
Status | Terminated |
Enrollment | 4 |
Est. completion date | November 11, 2022 |
Est. primary completion date | November 11, 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 44 Years |
Eligibility | Inclusion Criteria: - Delivered at the hospital system associated with the trial center - Delivered preterm singleton gestational age 24 weeks + 0 days to 34 weeks + 2 days - Willing to express milk at least 5 times every 24 hours during the observation period and 6 to 8 times every 24 hours during the treatment and post-treatment follow up - Produced < 200 mL milk in 24 hours prior to randomization - Delivered 96 to 192 (+4) hours prior to randomization Exclusion Criteria: - Pre-pregnancy body mass index (BMI) > 50 kg/m^2 - Mastitis - History of breast trauma, breast surgery, nipple piercing - Prolactin-releasing pituitary tumor, history of Sheehan's syndrome, pituitary surgery/radiation therapy - Pre-pregnancy insulin-dependent diabetes mellitus, polycystic ovarian syndrome. Note: gestational diabetes is allowed (also when requiring the use of insulin for treatment) - Unstable thyroid disease - Moderate or severe renal or hepatic impairment - Mental illness - Significant nasal congestion or mucous production - Use of anti-psychotic drugs within past 12 months |
Country | Name | City | State |
---|---|---|---|
United States | Ferring Investigational Site | Baltimore | Maryland |
United States | Ferring Investigational Site | Boston | Massachusetts |
United States | Ferring Investigational Site | Charleston | South Carolina |
United States | Ferring Investigational Site | Cincinnati | Ohio |
United States | Ferring Investigational Site | Houston | Texas |
United States | Ferring Investigational Site | New Haven | Connecticut |
United States | Ferring Investigational Site | Raleigh | North Carolina |
United States | Ferring Investigational Site | San Antonio | Texas |
United States | Ferring Investigational Site | South Bend | Indiana |
United States | Ferring Investigational Site | Valhalla | New York |
Lead Sponsor | Collaborator |
---|---|
Ferring Pharmaceuticals |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Volume of Mother's Own Milk (MoM) | Measured by weight in grams converted to volume in milliliters (mL) | Daily days 1 to 14 | |
Secondary | Time to First Occurrence of Daily Volume of MoM = 500 mL | Number of days | From randomization (Day 1) to Day 14 | |
Secondary | Time to First Occurrence of Daily Volume of MoM = 750 mL | Number of days | From randomization (Day 1) to Day 14 | |
Secondary | Proportion of Participants With a Daily Volume of MoM = 500 mL | Measured by weight in grams converted to volume in milliliters (mL) | Days 1 to 14 | |
Secondary | Proportion of Participants With a Daily Volume of MoM = 750 mL | Measured by weight in grams converted to volume in milliliters (mL) | Days 1 to 14 | |
Secondary | Volume of MoM | Measured by weight in grams converted to volume in milliliters (mL) | Days 15 to 17 | |
Secondary | Volume of MoM Fed to the Infant | Measured by weight in grams converted to volume in milliliters (mL) | Days 1 to 14 | |
Secondary | Volume of Formula/Donor Milk Fed to the Infant | Measured by weight in grams converted to volume in milliliters (mL) | Days 1 to 14 | |
Secondary | Merotocin Concentration in Milk | Day 3 | ||
Secondary | Merotocin Concentration in Milk | Day 10 | ||
Secondary | Change in Infant Body Weight | From baseline (Day 1) to Day 14 | ||
Secondary | Frequency of Adverse Events (AEs) in Maternal Participants | From Screening (0-144 hours of delivery) up to Day 18 | ||
Secondary | Intensity of AEs in Maternal Participants | From Screening (0-144 hours of delivery) up to Day 18 | ||
Secondary | Frequency of AEs in Infants | From screening until milk expressed Days 1-14 is consumed/discarded or infant discharged from neonatal intensive care unit (NICU), whichever occurs last. | ||
Secondary | Intensity of AEs in Infants | From screening until milk expressed Days 1-14 is consumed/discarded or infant discharged from neonatal intensive care unit (NICU), whichever occurs last. | ||
Secondary | Changes in Routine Safety Laboratory Parameters in Maternal Participants | From screening up to Day 15 | ||
Secondary | Proportion of Maternal Participants With Markedly Abnormal Changes in Laboratory Values | From screening up to Day 15 |
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