Merotocin in Mothers With Inadequate Milk Production and Infants Delivered Prematurely

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

Official Title
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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

Conditions
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Preterm Delivery, Inadequate Milk Production

Intervention / Treatment
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* Drug: Merotocin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Merotocin (a selective oxytocin-receptor agonist)<br> | Drug: Merotocin<br>* 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).<br>* Other names: FE 202767;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo nasal spray, 2 sprays with 1 spray in each nostril administered 6 to 8 times/day (Day 1 to Day 14).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volume of mother's own milk (MoM) | Measured by weight in grams converted to volume in milliliters (mL) | Daily days 1 to 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first occurrence of daily volume of MoM ≥ 500 mL | Number of days | From randomization (Day 1) to Day 14 | 
| Time to first occurrence of daily volume of MoM ≥ 750 mL | Number of days | 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) | 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) | Days 1 to 14 | 
| Volume of MoM | Measured by weight in grams converted to volume in milliliters (mL) | Days 15 to 17 | 
| Volume of MoM fed to the infant | Measured by weight in grams converted to volume in milliliters (mL) | Days 1 to 14 | 
| Volume of formula/donor milk fed to the infant | Measured by weight in grams converted to volume in milliliters (mL) | Days 1 to 14 | 
| Merotocin concentration in milk |  | Day 3 | 
| Merotocin concentration in milk |  | Day 10 | 
| Change in infant body weight |  | From baseline (Day 1) to Day 14 | 
| Frequency and intensity of adverse events (AEs) in maternal participants |  | From Screening (0-144 hours of delivery) up to Day 18 | 
| Frequency and 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 | 
| Proportion of maternal participants with markedly abnormal changes in laboratory values |  | From screening up to Day 15 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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inadequate milk production