NCT03591341

Melatonin Degradation Rate in Human Milk

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 10 (actual)
• Sponsor: Carmel Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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).

Detailed description

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.

Conditions

• Preterm Infant
• Lactation

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	melatonin level in pumped breast milk	diagnostic test of melatonin level in pumped breast milk

Timeline

• Start date: 2017-08-01
• Primary completion: 2017-11-30
• Completion: 2018-12-31
• First posted: 2018-07-19
• Last updated: 2019-02-01

Locations

1 site across 1 country: Israel