search
Back to results

Merotocin in Mothers With Inadequate Milk Production and Infants Delivered Prematurely (MERMAID)

Primary Purpose

Preterm Delivery, Inadequate Milk Production

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Merotocin
Placebo
Sponsored by
Ferring Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Preterm Delivery focused on measuring inadequate milk production

Eligibility Criteria

18 Years - 44 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Ferring Investigational Site
  • Ferring Investigational Site
  • Ferring Investigational Site
  • Ferring Investigational Site
  • Ferring Investigational Site
  • Ferring Investigational Site
  • Ferring Investigational Site
  • Ferring Investigational Site
  • Ferring Investigational Site
  • Ferring Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Merotocin (a selective oxytocin-receptor agonist)

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Volume of mother's own milk (MoM)
Measured by weight in grams converted to volume in milliliters (mL)

Secondary Outcome Measures

Time to first occurrence of daily volume of MoM ≥ 500 mL
Number of days
Time to first occurrence of daily volume of MoM ≥ 750 mL
Number of days
Proportion of participants with a daily volume of MoM ≥ 500 mL
Measured by weight in grams converted to volume in milliliters (mL)
Proportion of participants with a daily volume of MoM ≥ 750 mL
Measured by weight in grams converted to volume in milliliters (mL)
Volume of MoM
Measured by weight in grams converted to volume in milliliters (mL)
Volume of MoM fed to the infant
Measured by weight in grams converted to volume in milliliters (mL)
Volume of formula/donor milk fed to the infant
Measured by weight in grams converted to volume in milliliters (mL)
Merotocin concentration in milk
Merotocin concentration in milk
Change in infant body weight
Frequency and intensity of adverse events (AEs) in maternal participants
Frequency and intensity of AEs in infants
Changes in routine safety laboratory parameters in maternal participants
Proportion of maternal participants with markedly abnormal changes in laboratory values

Full Information

First Posted
August 26, 2015
Last Updated
January 13, 2023
Sponsor
Ferring Pharmaceuticals
search

1. Study Identification

Unique Protocol Identification Number
NCT02545127
Brief Title
Merotocin in Mothers With Inadequate Milk Production and Infants Delivered Prematurely
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Terminated
Why Stopped
Trial was prematurely terminated due to slow recruitment.
Study Start Date
May 28, 2021 (Actual)
Primary Completion Date
November 11, 2022 (Actual)
Study Completion Date
November 11, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ferring Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Delivery, Inadequate Milk Production
Keywords
inadequate milk production

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Merotocin (a selective oxytocin-receptor agonist)
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Merotocin
Other Intervention Name(s)
FE 202767
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo nasal spray, 2 sprays with 1 spray in each nostril administered 6 to 8 times/day (Day 1 to Day 14).
Primary Outcome Measure Information:
Title
Volume of mother's own milk (MoM)
Description
Measured by weight in grams converted to volume in milliliters (mL)
Time Frame
Daily days 1 to 14
Secondary Outcome Measure Information:
Title
Time to first occurrence of daily volume of MoM ≥ 500 mL
Description
Number of days
Time Frame
From randomization (Day 1) to Day 14
Title
Time to first occurrence of daily volume of MoM ≥ 750 mL
Description
Number of days
Time Frame
From randomization (Day 1) to Day 14
Title
Proportion of participants with a daily volume of MoM ≥ 500 mL
Description
Measured by weight in grams converted to volume in milliliters (mL)
Time Frame
Days 1 to 14
Title
Proportion of participants with a daily volume of MoM ≥ 750 mL
Description
Measured by weight in grams converted to volume in milliliters (mL)
Time Frame
Days 1 to 14
Title
Volume of MoM
Description
Measured by weight in grams converted to volume in milliliters (mL)
Time Frame
Days 15 to 17
Title
Volume of MoM fed to the infant
Description
Measured by weight in grams converted to volume in milliliters (mL)
Time Frame
Days 1 to 14
Title
Volume of formula/donor milk fed to the infant
Description
Measured by weight in grams converted to volume in milliliters (mL)
Time Frame
Days 1 to 14
Title
Merotocin concentration in milk
Time Frame
Day 3
Title
Merotocin concentration in milk
Time Frame
Day 10
Title
Change in infant body weight
Time Frame
From baseline (Day 1) to Day 14
Title
Frequency and intensity of adverse events (AEs) in maternal participants
Time Frame
From Screening (0-144 hours of delivery) up to Day 18
Title
Frequency and 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.
Title
Changes in routine safety laboratory parameters in maternal participants
Time Frame
From screening up to Day 15
Title
Proportion of maternal participants with markedly abnormal changes in laboratory values
Time Frame
From screening up to Day 15

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Compliance
Organizational Affiliation
Ferring Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Ferring Investigational Site
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Ferring Investigational Site
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
Ferring Investigational Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Ferring Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Ferring Investigational Site
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Facility Name
Ferring Investigational Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27610
Country
United States
Facility Name
Ferring Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Ferring Investigational Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Ferring Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Ferring Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Merotocin in Mothers With Inadequate Milk Production and Infants Delivered Prematurely

We'll reach out to this number within 24 hrs