Merotocin in Mothers With Inadequate Milk Production and Infants Delivered Prematurely

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

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

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