Merotocin in Mothers With Inadequate Milk Production and Infants Delivered Prematurely

Preterm Delivery Clinical Trial

— MERMAID  

Official 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02545127
• Other study ID #: 000050
• Status: Terminated
• Phase: Phase 2
• Start date: May 28, 2021
• Est. completion date: November 11, 2022

Study information

• Verified date: November 2022
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Inadequate Milk Production
• Premature Birth
• Preterm Delivery

Intervention

Drug:
• Merotocin
Merotocin nasal spray 400 µg/dose, 2 sprays with 1 spray in each nostril administered 6 to 8 times/day (Day 1 to Day 14).
• Placebo
Placebo nasal spray, 2 sprays with 1 spray in each nostril administered 6 to 8 times/day (Day 1 to Day 14).

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

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