Lactation Clinical Trial
Official title:
Recombinant Human Prolactin for Lactation Induction in Adoptive Mothers
The purpose of the study is to assess the safety and determine the effects of the hormone prolactin on lactation (breast milk production).
Subjects will participate in a randomized, double-blind, placebo-controlled, crossover trial
comparing breast pumping, alone, to breast pumping and r-hPRL. Subjects will have one week
of instruction with the breast pump alone. Subsequently, subjects will receive 2 weeks of
r-hPRL or placebo followed by 2 weeks of the alternate treatment.
Week 1: Study day 1, a baseline prolactin level will be obtained and subjects will be taught
to use an electrical, hospital grade breast pump by a designated lactation consultant.
Subjects will pump for 10 minutes at each breast. The total volume of milk will be recorded
in a diary throughout the study. Prolactin levels will be obtained every 10 minutes for 60
minutes after pumping begins, then every 30 minutes for a total of 3 hours. Subjects will
pump 3 times per day increasing to 8 times per day by the end of the first week and will
continue this regimen throughout the study.
Week 2: One week after the initial visit, subjects will return to the GCRC for re-evaluation
of the pumping technique and the first dose of medication. Subjects will pump for 10 minutes
at each breast as on day 1 and prolactin levels will be obtained every 10 minutes for 60
minutes, then every 30 minutes for a total of 3 hours. At 3 hours, r-hPRL 60 mg/kg or
placebo will be administered SC. Blood will be drawn every 10 minutes for 60 minutes, every
30 minutes for 2 hours, then at 4, 6 and 8 hours to obtain a peak prolactin level. Vital
signs will be monitored every 15 minutes for the first hour, then every 2 hours for a total
of 8 hours. Subjects will pump both breasts every 3 hours, starting after the r-hPRL or
placebo injection. Subjects will be taught to give themselves SC injections and will
administer their second dose of SC r-hPRL or placebo 12 hours after the first dose. Subjects
will continue SC r-hPRL or placebo administration every 12 hours for the next 14 days. They
will continue to pump daily, approximately every 3 hours, with a 5 hour break in the night
to sleep. Subjects will be asked to refrigerate all milk and bring it in to GCRC visits for
prolactin levels.
Subjects will return weekly for 4 additional visits (weeks 3, 4, 5, 6). At the weekly
visits, blood will be drawn at baseline for a prolactin level and r-hPRL or placebo will be
administered. Blood will then be drawn every 10 minutes for 60 minutes, then every 30
minutes for 2 hours, then every 2 hours for a total of 8 hours after the injection. Vital
signs will be monitored as described above. At the week 4 visit, subjects will be switched
to the alternate treatment for weeks 4 and 5. Subjects will be seen 14 days after their
final injection. A baseline prolactin level will be drawn, then milk will be pumped, as
previously. Blood will be drawn every 10 minutes for 60 minutes, then every 30 minutes for a
total of 3 hours. A 1 cc sample of the milk will also be obtained 14 days after the final
injection for analysis of composition. All side effects of r-hPRL will be recorded
throughout the study. All milk obtained during the study will be stored and the milk
composition will be determined before it is used. Infants receiving milk produced during the
study will initially be monitored in the GCRC under the supervision of a neonatologist.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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