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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nursing women | women who gave birth and are breast feeding their baby- melatonin level in pumped breast milk have been checked |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| melatonin level in pumped breast milk | Diagnostic Test | diagnostic test of melatonin level in pumped breast milk |
|
| Measure | Description | Time Frame |
|---|---|---|
| melatonin stability in human milk | melatonin levels in human milk samples are checked every hour after defrost | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
only women that gave birth and are breast feeding their babies
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healthy women who are breast feeding
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| Name | Affiliation | Role |
|---|---|---|
| michal molad, MD | Carmel Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carmel Medical Center | Haifa | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22205210 | Background | 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. | |
| 27121237 | Background | 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. |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D001942 | Breast Feeding |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| D000091642 | Urogenital Diseases |
| D005247 | Feeding Behavior |
| D001519 | Behavior |