Recombinant Human Prolactin for Lactation Induction
1 other identifier
interventional
11
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Sep 2004
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 9, 2005
CompletedFirst Posted
Study publicly available on registry
September 16, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedResults Posted
Study results publicly available
May 10, 2013
CompletedJanuary 3, 2018
December 1, 2017
6 years
September 9, 2005
February 5, 2013
December 31, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Breast Milk Volume Baseline to 7 Days
7 days
Secondary Outcomes (1)
Breast Milk Prolactin Levels
7 days
Study Arms (3)
1
ACTIVE COMPARATORPlacebo group normal saline twice per day
2
ACTIVE COMPARATORRecombinant human prolactin 60 mcg/kg every 12 hours
3
ACTIVE COMPARATORRecombinant human prolactin 60 mcg/kg alternating with normal saline placebo every 12 hours
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Related Publications (1)
Powe CE, Puopolo KM, Newburg DS, Lonnerdal B, Chen C, Allen M, Merewood A, Worden S, Welt CK. Effects of recombinant human prolactin on breast milk composition. Pediatrics. 2011 Feb;127(2):e359-66. doi: 10.1542/peds.2010-1627. Epub 2011 Jan 24.
PMID: 21262884DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Corrine Welt, MD
- Organization
- Massachusetts General Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Corrine K Welt, MD
Massachusetts General Hospital
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Medicine
Study Record Dates
First Submitted
September 9, 2005
First Posted
September 16, 2005
Study Start
September 1, 2004
Primary Completion
September 1, 2010
Study Completion
September 1, 2010
Last Updated
January 3, 2018
Results First Posted
May 10, 2013
Record last verified: 2017-12