Melatonin Degradation Rate in Human Milk

NCT ID: NCT03591341

Last Updated: 2019-02-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-08-01
• Study Completion Date: 2018-12-31

Brief 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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

nursing women

women who gave birth and are breast feeding their baby- melatonin level in pumped breast milk have been checked

melatonin level in pumped breast milk

Intervention Type: DIAGNOSTIC_TEST

diagnostic test of melatonin level in pumped breast milk

Interventions

melatonin level in pumped breast milk

diagnostic test of melatonin level in pumped breast milk

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Carmel Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

michal molad, MD

Role: PRINCIPAL_INVESTIGATOR

Carmel Medical Center

Locations

Carmel Medical Center

Haifa, , Israel

Countries

Israel

References

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.

Reference Type: BACKGROUND

PMID: 22205210 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27121237 (View on PubMed)

Other Identifiers

CMC-17-0035-CTIL

Identifier Type: -

Identifier Source: org_study_id