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Efficacy of Breast Milk in Healing of Skin Damage

NCT05390372 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2023-03-28

No results posted yet for this study

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 Intravenous (IV) vascular access fixation bands, and whose skin has not been subjected to any other application before. Calculation of the sample number of the research; It was determined that at least 24 newborns should be assigned to each group (α = 0.05 and β = 0.19) to show that the 1 degree difference between the cream group and the breast milk group was significant for 80.7% strength. It is planned to take a premature baby. As data collection tools, Premature Babies Descriptive Information Form, Newborn Skin Condition Assessment Scale, Medical Adhesives and Solvents Used in the Neonatal Intensive Care Unit, Human Milk and routine care will be used.

Conditions

  • Milk Expression, Breast

Interventions

OTHER

human milk

For skin damage care of preterm newborns randomly assigned to the breast milk group, their own breast milk will be applied topically once every 60 minutes until complete healing. Skin damage in newborns will be evaluated by an independent nurse and specialist doctor for 60 minutes during the treatment, and the score will be given and recorded. A minimum decrease of 1 point in the skin condition assessment scale score will be considered to indicate 'improvement'. The decision that the skin integrity of the newborn is completely healed will be made by the neonatal doctor independent of the trial. Areas between 0-3 on the newborn skin condition assessment scale will be considered healed. Breastfeeding does not have any side effects in preterm newborns.

OTHER

Routine care group

cream applied as part of hospital routine practice

Sponsors & Collaborators

  • Karamanoğlu Mehmetbey University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
30 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-01
Primary Completion
2022-08-27
Completion
2022-11-01

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05390372 on ClinicalTrials.gov