Recombinant Human Prolactin for Lactation Induction
Condition: Lactation
Study type: Interventional
Phase: Phase 2

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 lactation consultant will educate all subjects in the proper technique for
      pumping on the first day of the study and will evaluate their technique on day 5 and day 8 of
      the study. The lactation consultant will also instruct patients to record the volume of milk
      pumped and the time of each pumping episode. Subjects will be encouraged to have direct
      contact with their infants prior to pumping. All infant contact, infant latching onto the
      breast and mother's stress level will also be recorded throughout the study. Starting at 8 am
      on day 1, a hospital grade breast pump will be used to drain both breasts as confirmed by the
      absence of milk flow for 2 min during each episode of pumping and by palpation. Pumping will
      be performed in this manner every 3 hours around the clock. Subjects will be allowed a 5 hour
      window to sleep, however, as long as the total number of pumping episodes equals 8 in 24
      hours.

      During the first episode of pumping, a baseline prolactin level will be drawn immediately
      before the start of a pumping and repeated at 10 min intervals for 60 min, and then every 30
      min for a total of 3 hours to document the peak prolactin level. An intravenous line will be
      placed to draw blood. Subsequently, subjects will be randomized to receive prolactin or
      placebo. On the morning of days 2, 5 and 8, blood will be collected for a prolactin level
      before medication injection. Subsequently, prolactin 60 mg/kg or placebo will be injected
      subcutaneously by the study nurse 3 hrs after the last pumping episode. On days 2 and 8,
      additional blood will be collected every 10 min for the first hour, every 30 min for hour 2
      and 3, then at 4, 6 and 8 hours after injection to determine the peak prolactin level during
      a pumping session. Subjects will then drain both breasts as confirmed by the absence of milk
      flow for 2 min during each episode of pumping and by palpation and milk volume recorded. The
      subjects' vital signs will be monitored immediately before and every 15 minutes for 1 hr,
      every 30 min for hours 2 and 3, and then at 4, 6 and 8 hours after injection of
      prolactin/placebo. Temperature will be measured before the injection, every hour for hours 2
      and 3, and then at 4, 6 and 8 hours after injection of placebo/prolactin. If there are no
      changes in vital signs, on days 5 and 8 vital signs will be monitored at baseline, only.
      Subjects will be taught to do SC injections on their own and will administer their second
      dose of SC r-hPRL or placebo 12 hours after the first dose. Subjects will continue every 12
      hour SC r-hPRL or placebo administration for the next 7 days. Subjects will be asked to
      refrigerate all milk and bring it in to GCRC visits so that the volume that is recorded can
      be confirmed and for testing the milk composition and prolactin level before it is given to
      the infants. The final prolactin injection will be given on the evening of study day 8. All
      side effects in the mother and baby will be recorded daily throughout the study. Subjects
      will return for a final outpatient visit on day 16, to determine if any treatment effect
      persists. During this visit, milk will be pumped at baseline and volume recorded. In
      addition, blood will be drawn at 10 min intervals for 60 min, and then every 30 min for a
      total of 3 hours to document the peak prolactin level. Subjects will turn in their pumping
      diary the next day.
    

Intervention name(s): Recombinant Human Prolactin; Recombinant human prolactin; Normal Saline
Intervention type(s): Drug; Biological; Biological
Intervention description(s): 60 mcg/kg every 12 hours; 60 mcg/kg given every 12 hours or every 24 hours; twice per day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Lactation; Breastfeeding; Premature infants; Prolactin; Primary lactation insufficiency