Merotocin in Mothers With Inadequate Milk Production and Infants Delivered Prematurely
Purpose
Induction and support of lactation in women with preterm delivery and inadequate milk production.
Conditions
- Preterm Delivery
- Inadequate Milk Production
Eligibility
- Eligible Ages
- Between 18 Years and 44 Years
- Eligible Genders
- Female
- Accepts Healthy Volunteers
- No
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
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Merotocin (a selective oxytocin-receptor agonist) |
|
|
|
Placebo Comparator Placebo |
|
More Details
- Status
- Terminated
- Sponsor
- Ferring Pharmaceuticals