Melatonin Degradation Rate in Human Milk

Preterm Infant Clinical Trial

Official title:

Melatonin Degradation Rate in Human Milk

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03591341
• Other study ID #: CMC-17-0035-CTIL
• Status: Completed
• Start date: August 1, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: July 2018
• Source: Carmel Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 31, 2018
• Est. primary completion date: November 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Women that are breast feeding and will pump and freeze a milk sample at 03:00 AM

2. Women at least one week after delivery

Exclusion Criteria:

1. A sample that will not be freezed right after the pump

2. Women that are taking hypnotic drugs

3. Women that are taking melatonin

Related Conditions & MeSH terms

• Lactation
• Preterm Infant

Intervention

Diagnostic Test:
• melatonin level in pumped breast milk
diagnostic test of melatonin level in pumped breast milk

Locations

Country	Name	City	State
Israel	Carmel Medical Center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Carmel Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (2)

Cohen Engler A, Hadash A, Shehadeh N, Pillar G. Breastfeeding may improve nocturnal sleep and reduce infantile colic: potential role of breast milk melatonin. Eur J Pediatr. 2012 Apr;171(4):729-32. doi: 10.1007/s00431-011-1659-3. Epub 2011 Dec 29. — View Citation

Katzer D, Pauli L, Mueller A, Reutter H, Reinsberg J, Fimmers R, Bartmann P, Bagci S. Melatonin Concentrations and Antioxidative Capacity of Human Breast Milk According to Gestational Age and the Time of Day. J Hum Lact. 2016 Nov;32(4):NP105-NP110. doi: 10.1177/0890334415625217. Epub 2016 Jul 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	melatonin stability in human milk	melatonin levels in human milk samples are checked every hour after defrost	24 hours