Merotocin in Mothers With Inadequate Milk Production and Infants Delivered Prematurely

• Status: Recruiting
• Trial end date: 2022-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ferring Pharmaceuticals

Criteria

Inclusion Criteria:

• Delivered at hospital associated with trial center

• Delivered preterm singleton gestational age 24 weeks + 0 days to 31 weeks + 6 days

• Willing to express milk 6 to 8 times/24 hours

• Produced < 200 mL milk in 24 hours prior to randomization

• Delivered 96 to 144 hours prior to randomization

Exclusion Criteria:

• Pre-pregnancy body mass index (BMI) > 40 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

• 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