Skip to main content
OpenTrials
Completed

NCT Number: NCT03591341

Melatonin Degradation Rate in Human Milk

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Preterm Infant Behavior Breast Feeding Feeding Behavior Female Urogenital Diseases and Pregnancy Complications Lactation Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Carmel Medical Center

Haifa, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women that are breast feeding and will pump and freeze a milk sample at 03:00 AM
  • Women at least one week after delivery

Exclusion criteria

  • A sample that will not be freezed right after the pump
  • Women that are taking hypnotic drugs
  • Women that are taking melatonin

Treatment and study plan

melatonin level in pumped breast milk

Diagnostic Test

diagnostic test of melatonin level in pumped breast milk

Primary outcomes

  1. melatonin stability in human milk

    Time frame: 24 hours

    melatonin levels in human milk samples are checked every hour after defrost

Sponsors and collaborators

Lead sponsor

Carmel Medical Center

Other

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Jul 19, 2018
Registry last updated
Feb 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.