An observational study in Preterm Infant and Lactation, sponsored by Carmel Medical Center. Completed at 1 site in Israel. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-01.
Sponsored by Carmel Medical Center · Observational
Our long term hypothesis is that giving premature infants breast milk that was pumped during the night and has high concentration of melatonin will improve outcome of several clinical conditions related to premature infants. Prior to testing this, we need to learn the pharmacokinetics of melatonin in vitro.
In this preliminary research we would like to check the levels of melatonin in breast milk pumped during the night, and evaluate the rate of degradation of the melatonin to determine the half life of melatonin in pumped breast milk (in vitro).
The study includes 10 nursing women. Each woman will bring a frozen 5 ml sample of breast milk that was pumped at 03:00 AM. The samples will be collected at the NICU department of Carmel Medical Center and will be stored at deep freeze (-20°C). The samples will be numerically coded and will be kept anonimously. After defrosting the samples, melatonin concentration will be checked in the hospital laboratory every hour, for 4 hours. If meltonin levels will be detectable after 4 hours, continous measurements will be done at 8 hours and at 12 hours after defrosting. The samples will be tested with IBL Melatonin ELISA kit. For control we will use breast milk that was pumped at 10:00 am (when melatonin excretion is minimal). At the end of the analysis the samples will be thrown away.
Carmel Medical Center is the lead sponsor of 112 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
healthy women who are breast feeding
Exclusion Criteria:
women who gave birth and are breast feeding their baby- melatonin level in pumped breast milk have been checked
Diagnostic Test: melatonin level in pumped breast milk
diagnostic test of melatonin level in pumped breast milk
melatonin stability in human milk
melatonin levels in human milk samples are checked every hour after defrost
Time frame: 24 hours
Plan to share: No
This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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Carmel Medical Center