Status:
COMPLETED
Efficacy of Breast Milk in Healing of Skin Damage
Lead Sponsor:
Karamanoğlu Mehmetbey University
Conditions:
Milk Expression, Breast
Eligibility:
All Genders
1-30 years
Phase:
NA
Brief Summary
The population of the research will be preterm infants born 35-36 weeks of gestation, hospitalized in the Neonatal Intensive Care Unit of Karaman State Hospital, whose skin is damaged due to Intraveno...
Detailed Description
Randomization The process of inclusion of newborns into groups will be randomly assigned using the computer program (https://www.randomizer.org). Which letter will be the breast milk or routine care g...
Eligibility Criteria
Inclusion
- Written and verbal consent of the parents,
- The newborn is less than 37 weeks of gestation,
- Being in the Neonatal Intensive Care Unit,
- The intravenous catheter has been fixed to the skin with a silk patch,
- For intravenous catheter fixation, the bands remain on the skin for a minimum of 24 hours and a maximum of 32 hours,
- While removing the adhesive tape, remove it slowly and carefully by softening the tape with cotton moistened with water,
- The parent speaks and understands Turkish comfortably,
- Stable health status
- Having spontaneous breathing
- Not being exposed to a painful procedure at least half an hour before the interventions.
- Not taking opioid or non-opioid analgesics
- Not receiving any antibiotic treatment,
- Having breast milk
Exclusion
- Parent's inability to speak and understand Turkish easily,
- Parents do not give written and verbal consent,
- Intravenous catheter not fixed to the skin with a silk patch,
- For intravenous catheter fixation, the bands should not remain on the skin for a minimum of 24 hours and a maximum of 32 hours,
- Removal of the intravenous catheter from the skin using a solvent solution,
- Having ventilator support
- Presence of congenital anomaly
- Using analgesic / narcotic analgesic drugs
- Receiving any antibiotic treatment,
- Continuous sedative treatment
- Discontinuation of topical breast milk or cream application procedure for any reason
- Parent's wish to leave the study
Key Trial Info
Start Date :
August 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2022
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT05390372
Start Date
August 1 2022
End Date
November 1 2022
Last Update
March 28 2023
Active Locations (1)
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1
Ayşe Sonay Türkmen
Karaman, Turkey (Türkiye), 70100