Status:
COMPLETED
Recombinant Human Prolactin for Lactation Induction
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Lactation
Eligibility:
FEMALE
18-45 years
Phase:
PHASE2
Brief Summary
The purpose of the study is to assess the safety and determine the effects of the hormone prolactin on lactation (breast milk production).
Detailed Description
The study is a randomized, double blind, placebo controlled trial. Subjects will be admitted to the General Clinical Research Center (GCRC) as outpatients to undergo their baseline pumping study. One ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00181610
Start Date
September 1 2004
End Date
September 1 2010
Last Update
January 3 2018
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114