Merotocin in Mothers With Inadequate Milk Production and Infants Delivered Prematurely

Phase 2

Terminated

Conditions: Preterm Delivery
Inadequate Milk Production

Interventions: Drug: Placebo
Drug: Merotocin

Registration Number: NCT02545127

Lead Sponsor: Ferring Pharmaceuticals

Brief Summary: Induction and support of lactation in women with preterm delivery and inadequate milk production.

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: Female

Target Recruitment: 4

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Merotocin (a selective oxytocin-receptor agonist)	Merotocin	-

Primary Outcome Measures

Name	Time	Method
Volume of Mother's Own Milk (MoM)	Daily days 1 to 14	Measured by weight in grams converted to volume in milliliters (mL)

Secondary Outcome Measures

Name	Time	Method
Time to First Occurrence of Daily Volume of MoM ≥ 500 mL	From randomization (Day 1) to Day 14	Number of days
Proportion of Maternal Participants With Markedly Abnormal Changes in Laboratory Values	From screening up to Day 15
Time to First Occurrence of Daily Volume of MoM ≥ 750 mL	From randomization (Day 1) to Day 14	Number of days
Proportion of Participants With a Daily Volume of MoM ≥ 500 mL	Days 1 to 14	Measured by weight in grams converted to volume in milliliters (mL)
Proportion of Participants With a Daily Volume of MoM ≥ 750 mL	Days 1 to 14	Measured by weight in grams converted to volume in milliliters (mL)
Volume of MoM	Days 15 to 17	Measured by weight in grams converted to volume in milliliters (mL)
Volume of MoM Fed to the Infant	Days 1 to 14	Measured by weight in grams converted to volume in milliliters (mL)
Volume of Formula/Donor Milk Fed to the Infant	Days 1 to 14	Measured by weight in grams converted to volume in milliliters (mL)
Merotocin Concentration in Milk	Day 10
Change in Infant Body Weight	From baseline (Day 1) to Day 14
Frequency of Adverse Events (AEs) in Maternal Participants	From Screening (0-144 hours of delivery) up to Day 18
Intensity of AEs in Maternal Participants	From Screening (0-144 hours of delivery) up to Day 18
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.
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.
Changes in Routine Safety Laboratory Parameters in Maternal Participants	From screening up to Day 15