Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03591341
Other study ID # CMC-17-0035-CTIL
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Not yet recruiting NCT04062513 - Olfactive Stimulation Interventions With Mothers' Milk on Preterm Pain Response N/A
Completed NCT03412578 - Effect of Tactile/Kinaesthetic Massage Therapy on DXA Parameter of Preterm Infants N/A
Completed NCT03166722 - Cerebral Regional Tissue Oxygen Saturation to Guide Oxygen Delivery in Preterm Neonates During Immediate Transition N/A
Enrolling by invitation NCT03212547 - The Effect of a Neonatologist's Standardized Guidance Intervention on Preterm Infants With Relational Withdrawal. N/A
Completed NCT03931902 - The Comparison of Laryngeal Mask Airway and Endotracheal Tube in General Anesthesia for Premature Neonates N/A
Completed NCT03302000 - Visual Stimulation of Preterm Infants N/A
Completed NCT03731546 - Effect of Delayed Cord Clamping in Preterm Neonates With Placental Insufficiency N/A
Completed NCT03104946 - To Research the Relation Between Neonatal Morbidities and Poor Outcome in Preterm Infants N/A
Completed NCT03704012 - Efficacy of Massage Applied by the Parents in Hospitalized Premature Birth (PreMas) N/A
Suspended NCT03220282 - The Milk, Growth and Microbiota Study N/A
Active, not recruiting NCT03232931 - Trial to Improve Multisensory Neural Processing, Language & Motor Outcomes in Preterm Infants N/A
Completed NCT03242057 - Comparison of Primary Extubation Failure Between NIPPV and NI-NAVA N/A
Completed NCT04089540 - New Intubation Method to Achieve Circulatory Stability and to Reduce Number of Intubation Attempts in Neonates N/A
Not yet recruiting NCT02528851 - Cardiorespiratory Effects of "Higher" Versus "Equivalent" CPAP Upon Extubation From High EAP in Preterm Infants N/A
Completed NCT01959737 - Delivery Room Skin-to-skin Study N/A
Completed NCT03700463 - Executive Functions and Preterm Children in 3 to 4 Year Old
Completed NCT02811432 - Kangaroo Mother Care Before Stabilisation Amongst Low Birth Weight Neonates in Africa N/A
Completed NCT03728764 - Growth and Safety of a Two-stage Feeding System in Preterm Infants N/A
Completed NCT04382976 - The Incidence and the Risk Factors of Nephrocalcinosis in Very Preterm Infants
Completed NCT03748914 - C-UCM and Cerebral Oxygenation and Perfusion N/A