Efficacy of Breast Milk in Healing of Skin Damage

NCT05390372 | Completed

• 1 other identifier: Humanmilk
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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 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

Outcome Measures

Primary Outcomes (1)

• skin damage

  The change in skin damage after the intervention with newborn skin condition assessment scalewill be monitored.

  3 weeks

Study Arms (2)

humanmilk

EXPERIMENTAL

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: human milk

routine care group

EXPERIMENTAL

cream applied as part of hospital routine practice

Other: Routine care group

Interventions

human milk OTHER

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.

humanmilk

Routine care group OTHER

cream applied as part of hospital routine practice

routine care group

Eligibility Criteria

• Age: 1 Day - 30 Days
• Gender Eligibility Details: preterm newborns
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Karamanoğlu Mehmetbey University: lead

Study Sites (1)

Ayşe Sonay Türkmen

Karaman, 70100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Milk Expression

Interventions

Milk, Human

Condition Hierarchy (Ancestors)

Breast Feeding; Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Milk; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Dairy Products; Food; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.Dr

Study Record Dates

• First Submitted: May 11, 2022
• First Posted: May 25, 2022
• Study Start: August 1, 2022
• Primary Completion: August 27, 2022
• Study Completion: November 1, 2022
• Last Updated: March 28, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)