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

Ferring

Status and phase: Terminated; Phase 2

Conditions: Inadequate Milk Production; Preterm Delivery

Treatments: Drug: Merotocin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02545127

000050

Details and patient eligibility

About

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

Enrollment: 4 patients

Sex: Female

Ages: 18 to 44 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

4 participants in 2 patient groups, including a placebo group

Merotocin (a selective oxytocin-receptor agonist)

Experimental group

Treatment:

Drug: Merotocin

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo