Induction and support of lactation in women with preterm delivery and inadequate milk production.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
4
Ferring Investigational Site
New Haven, Connecticut, United States
Ferring Investigational Site
South Bend, Indiana, United States
Ferring Investigational Site
Baltimore, Maryland, United States
Volume of Mother's Own Milk (MoM)
Measured by weight in grams converted to volume in milliliters (mL)
Time frame: Daily days 1 to 14
Time to First Occurrence of Daily Volume of MoM ≥ 500 mL
Number of days
Time frame: From randomization (Day 1) to Day 14
Time to First Occurrence of Daily Volume of MoM ≥ 750 mL
Number of days
Time frame: From randomization (Day 1) to Day 14
Proportion of Participants With a Daily Volume of MoM ≥ 500 mL
Measured by weight in grams converted to volume in milliliters (mL)
Time frame: Days 1 to 14
Proportion of Participants With a Daily Volume of MoM ≥ 750 mL
Measured by weight in grams converted to volume in milliliters (mL)
Time frame: Days 1 to 14
Volume of MoM
Measured by weight in grams converted to volume in milliliters (mL)
Time frame: Days 15 to 17
Volume of MoM Fed to the Infant
Measured by weight in grams converted to volume in milliliters (mL)
Time frame: Days 1 to 14
Volume of Formula/Donor Milk Fed to the Infant
Measured by weight in grams converted to volume in milliliters (mL)
Time frame: Days 1 to 14
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Ferring Investigational Site
Boston, Massachusetts, United States
Ferring Investigational Site
Valhalla, New York, United States
Ferring Investigational Site
Raleigh, North Carolina, United States
Ferring Investigational Site
Cincinnati, Ohio, United States
Ferring Investigational Site
Charleston, South Carolina, United States
Ferring Investigational Site
Houston, Texas, United States
Ferring Investigational Site
San Antonio, Texas, United States
Merotocin Concentration in Milk
Time frame: Day 3
Merotocin Concentration in Milk
Time frame: Day 10
Change in Infant Body Weight
Time frame: From baseline (Day 1) to Day 14
Frequency of Adverse Events (AEs) in Maternal Participants
Time frame: From Screening (0-144 hours of delivery) up to Day 18
Intensity of AEs in Maternal Participants
Time frame: From Screening (0-144 hours of delivery) up to Day 18
Frequency of AEs in Infants
Time frame: From screening until milk expressed Days 1-14 is consumed/discarded or infant discharged from neonatal intensive care unit (NICU), whichever occurs last.
Intensity of AEs in Infants
Time frame: From screening until milk expressed Days 1-14 is consumed/discarded or infant discharged from neonatal intensive care unit (NICU), whichever occurs last.
Changes in Routine Safety Laboratory Parameters in Maternal Participants
Time frame: From screening up to Day 15
Proportion of Maternal Participants With Markedly Abnormal Changes in Laboratory Values
Time frame: From screening up to Day 15