Study Stopped
The trial was prematurely terminated. Termination was not because of safety concerns but due to slow recruitment.
Merotocin in Mothers With Inadequate Milk Production and Infants Delivered Prematurely
MERMAID
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
1 other identifier
interventional
4
1 country
10
Brief Summary
Induction and support of lactation in women with preterm delivery and inadequate milk production.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started May 2021
Shorter than P25 for phase_2
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 26, 2015
CompletedFirst Posted
Study publicly available on registry
September 9, 2015
CompletedStudy Start
First participant enrolled
May 28, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 11, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 11, 2022
CompletedResults Posted
Study results publicly available
February 7, 2024
CompletedFebruary 7, 2024
November 1, 2022
1.5 years
August 26, 2015
November 2, 2023
January 15, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Volume of Mother's Own Milk (MoM)
Measured by weight in grams converted to volume in milliliters (mL)
Daily days 1 to 14
Secondary Outcomes (16)
Time to First Occurrence of Daily Volume of MoM ≥ 500 mL
From randomization (Day 1) to Day 14
Time to First Occurrence of Daily Volume of MoM ≥ 750 mL
From randomization (Day 1) to Day 14
Proportion of Participants With a Daily Volume of MoM ≥ 500 mL
Days 1 to 14
Proportion of Participants With a Daily Volume of MoM ≥ 750 mL
Days 1 to 14
Volume of MoM
Days 15 to 17
- +11 more secondary outcomes
Study Arms (2)
Merotocin (a selective oxytocin-receptor agonist)
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
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 nasal spray, 2 sprays with 1 spray in each nostril administered 6 to 8 times/day (Day 1 to Day 14).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Ferring Investigational Site
New Haven, Connecticut, 06520, United States
Ferring Investigational Site
South Bend, Indiana, 46601, United States
Ferring Investigational Site
Baltimore, Maryland, 21201, United States
Ferring Investigational Site
Boston, Massachusetts, 02115, United States
Ferring Investigational Site
Valhalla, New York, 10595, United States
Ferring Investigational Site
Raleigh, North Carolina, 27610, United States
Ferring Investigational Site
Cincinnati, Ohio, 45229, United States
Ferring Investigational Site
Charleston, South Carolina, 29425, United States
Ferring Investigational Site
Houston, Texas, 77030, United States
Ferring Investigational Site
San Antonio, Texas, 78229, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Clinical Compliance
- Organization
- Ferring Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Global Clinical Compliance
Ferring Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 26, 2015
First Posted
September 9, 2015
Study Start
May 28, 2021
Primary Completion
November 11, 2022
Study Completion
November 11, 2022
Last Updated
February 7, 2024
Results First Posted
February 7, 2024
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share