Recombinant Human Prolactin for Lactation Induction

• Status: Completed
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of the study is to assess the safety and determine the effects of the hormone prolactin on lactation (breast milk production).

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

Details

• Lead Sponsor: Massachusetts General Hospital

Criteria

Inclusion Criteria:

• Healthy women, aged 18-45 years

• Lactation insufficiency postpartum

• Subjects will be women with children in the neonatal Intensive Care Unit (ICU) who are pumping breast milk for their infant's nutritional support and to maintain their milk supply.

• Subjects will have given birth at a gestational age of at least 24 weeks, and will generally be recruited 4-8 weeks postpartum.

Exclusion Criteria:

• Medications known to increase prolactin

• Anatomical breast abnormalities

• Use of medication contraindicated in breastfeeding mothers

• Allergies to mannitol

• Current use of hormonal contraception

• Previous mammoplasty or breast augmentation, unless they have successfully nursed an infant for 3 months in the past without requiring supplemental formula.