Milk Expression, BreastNCT05390372
Efficacy of Breast Milk in Healing of Skin Damage
A study testing human milk and Routine care group in people with Milk Expression, Breast, run by Karamanoğlu Mehmetbey University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 30 daysHealthy volunteers can take part
- Conditions the study is for
- Milk Expression, Breast
- What is being tested?
- human milk and Routine care group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2022to 1 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 30 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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,
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Breast Milk in Healing of Skin Damage Due to Tape Peeling in Premature Babies: A Randomized Study
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.
Read the 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 group was determined by the closed opaque envelope method at the beginning of the study. Accordingly, the letter A will be used for the breast milk group and the letter B will be used for the cream group. According to the black bag drawn randomly by an independent nurse from the research, which group it will be in will be determined.
Hypotheses H1: The use of topical breast milk is more effective than the routine care in the healing of skin damage due to tape stripping, which is used in the detection of IV vascular access in premature babies.
H2: The use of routine care is more effective than topical breast milk in the healing of skin damage due to tape stripping, which is used in the detection of IV vascular access in premature babies.
Variables of the Study Dependent variables: Scores from the newborns' "Neonatal Skin Condition Assessment Scale".
Independent variables: Sociodemographic characteristics, two different methods including breast milk and routine care.
Data Collection Tools Information Form for Premature Babies It consisted of questions including information about the gender, gestational week, current weight, birth weight, postnatal age, length of hospitalization, and nutritional status of the premature newborns included in the study.
Newborn Skin Condition Rating Scale It is a measurement tool developed by Lund and Osborne (2004) to evaluate the skin condition of term, premature or post-term, healthy or sick newborn babies. Turkish validity and reliability of the scale Calisir et al. (2016) with 96 newborn babies who were hospitalized in Adnan Menderes University Neonatal Intensive Care Unit and selected using the improbable method. The scale consists of three items and each item includes an evaluation criterion. These are respectively dryness, erythema and deterioration of skin integrity/peeling. Each item of the scale, which was developed as a three-point Likert scale, gets points from 1 to 3. The lowest score that can be obtained from the scale is 3 and the highest score is 9, and a high total score indicates that the newborn's skin condition is bad.
Medical Adhesives and Solvents Used in the Neonatal Intensive Care Unit Adhesives in the form of fabric, silk, polyester, paper, plastic, foam, polyurethane film used in neonatal intensive care. It is used to fix IV routes. It is recommended not to use adhesive tape solvents because of the dangers of toxicity in absorption and skin irritation in premature skin. Silk plaster is used in the neonatal intensive care unit, which is included in the research, and isotonic liquid is used as tape solvent.
Routine care: The routine care, which is routinely used in the treatment of tape stripping in the neonatal intensive care unit, will be used within the scope of the research. Features of the routine care used routinely by the clinic: It can be used in children from birth. The cream has no known contraindications. The cream is applied to the lesioned area of the skin as a thin layer. Instructions for proper use and dose/frequency of administration: Cream; It is applied to the lesioned area several times a day. There is no time limit on the use of the cream.
Research Implementation Plan Preliminary Application of the Research; In the research; In order to evaluate the effects of breast milk and routine care on the healing of skin damage due to tape peeling, pre-treatment will be applied to 4 preterm newborns in the newborn intensive care unit of Karaman Training and Research Hospital. Thus, the difficulties in the application of the methods were determined in advance and it was planned to eliminate these problems by the researcher.
First Stage;
- Newborns to be included in this study receive care and treatment in an incubator because they are hospitalized in the neonatal intensive care unit.
- The follow-up and follow-up of the newborn's skin evaluation at all stages of this study will be followed and evaluated by the physician of the neonatal intensive care unit.
- The silk patch used in the IV catheter fixation of the newborn will be slowly removed by the neonatal nurse parallel to the skin. In order to facilitate the removal of the plaster, the plaster will be removed slowly and carefully with cotton moistened with isotonic liquid, softening the tape.
- In the first stage, a nurse and a specialist doctor who are independent of the study will evaluate the skin damage caused by the removal of intravenous vascular access in preterm newborns by using the "Neonatal Skin Condition Assessment Scale" by the observers, and the score will be given and recorded.
- Alcohol-free cotton wipes dipped in water will be used to clean the damaged skin area of newborns in both groups.
- Preterm newborns will be randomly assigned to 2 groups as breast milk and routine care group.
Second Stage;
Breast Milk Group:
For skin damage care of preterm newborns who are randomly assigned to the breast milk group, their own breast milk will be applied topically once in 60 minutes until complete healing. A decrease of at least 1 point in the 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 (Qu-Yang et al., 2013; Rosali et al., 2015; Rodrigues et al., 2017).
Routine Care Group:
For skin damage care of preterm newborns who are randomly assigned to the cream group, the cream will be applied topically once in 60 minutes until complete healing. A reduction of 1 point 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.
In both groups, skin damage will be evaluated once before the procedure and 10 times after the procedure (with an interval of one hour), a total of 11 times.
- Conditions
- Milk Expression, Breast
- Being tested
- human milk, Routine care group
- Medical subject headings
- Breast Milk Expression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
human milkOther
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.
Routine care groupOther
cream applied as part of hospital routine practice
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: human milk |
| routine care group | Experimental | cream applied as part of hospital routine practice Receives: Other: Routine care group |
What is being measured
The primary outcome is the main question the study is designed to answer.
skin damage
The change in skin damage after the intervention with newborn skin condition assessment scalewill be monitored.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start1 Aug 2022
- Primary completion27 Aug 2022
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Milk Expression, BreastStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karamanoğlu Mehmetbey University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayse Sonay Turkmen, Prof.Dr, Karamanoğlu Mehmetbey University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05390372
- Sponsor's protocol ID
- Humanmilk
- Status last verified
- Mar 2023
- First submitted
- 11 May 2022
- Last updated
- 28 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Breast Milk in Healing of Skin Damage Due to Tape Peeling in Premature Babies: A Randomized Study
- ClinicalTrials.gov ID
- NCT05390372
- Acronym / sponsor ID
- Humanmilk
- Conditions
- Milk Expression, Breast
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Karamanoğlu Mehmetbey UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 27 Aug 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 25 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 group was determined by the closed opaque envelope method at the beginning of the study. Accordingly, the letter A will be used for the breast milk group and the letter B will be used for the cream group. According to the black bag drawn randomly by an independent nurse from the research, which group it will be in will be determined.
Hypotheses H1: The use of topical breast milk is more effective than the routine care in the healing of skin damage due to tape stripping, which is used in the detection of IV vascular access in premature babies.
H2: The use of routine care is more effective than topical breast milk in the healing of skin damage due to tape stripping, which is used in the detection of IV vascular access in premature babies.
Variables of the Study Dependent variables: Scores from the newborns' "Neonatal Skin Condition Assessment Scale".
Independent variables: Sociodemographic characteristics, two different methods including breast milk and routine care.
Data Collection Tools Information Form for Premature Babies It consisted of questions including information about the gender, gestational week, current weight, birth weight, postnatal age, length of hospitalization, and nutritional status of the premature newborns included in the study.
Newborn Skin Condition Rating Scale It is a measurement tool developed by Lund and Osborne (2004) to evaluate the skin condition of term, premature or post-term, healthy or sick newborn babies. Turkish validity and reliability of the scale Calisir et al. (2016) with 96 newborn babies who were hospitalized in Adnan Menderes University Neonatal Intensive Care Unit and selected using the improbable method. The scale consists of three items and each item includes an evaluation criterion. These are respectively dryness, erythema and deterioration of skin integrity/peeling. Each item of the scale, which was developed as a three-point Likert scale, gets points from 1 to 3. The lowest score that can be obtained from the scale is 3 and the highest score is 9, and a high total score indicates that the newborn's skin condition is bad.
Medical Adhesives and Solvents Used in the Neonatal Intensive Care Unit Adhesives in the form of fabric, silk, polyester, paper, plastic, foam, polyurethane film used in neonatal intensive care. It is used to fix IV routes. It is recommended not to use adhesive tape solvents because of the dangers of toxicity in absorption and skin irritation in premature skin. Silk plaster is used in the neonatal intensive care unit, which is included in the research, and isotonic liquid is used as tape solvent.
Routine care: The routine care, which is routinely used in the treatment of tape stripping in the neonatal intensive care unit, will be used within the scope of the research. Features of the routine care used routinely by the clinic: It can be used in children from birth. The cream has no known contraindications. The cream is applied to the lesioned area of the skin as a thin layer. Instructions for proper use and dose/frequency of administration: Cream; It is applied to the lesioned area several times a day. There is no time limit on the use of the cream.
Research Implementation Plan Preliminary Application of the Research; In the research; In order to evaluate the effects of breast milk and routine care on the healing of skin damage due to tape peeling, pre-treatment will be applied to 4 preterm newborns in the newborn intensive care unit of Karaman Training and Research Hospital. Thus, the difficulties in the application of the methods were determined in advance and it was planned to eliminate these problems by the researcher.
First Stage;
- Newborns to be included in this study receive care and treatment in an incubator because they are hospitalized in the neonatal intensive care unit.
- The follow-up and follow-up of the newborn's skin evaluation at all stages of this study will be followed and evaluated by the physician of the neonatal intensive care unit.
- The silk patch used in the IV catheter fixation of the newborn will be slowly removed by the neonatal nurse parallel to the skin. In order to facilitate the removal of the plaster, the plaster will be removed slowly and carefully with cotton moistened with isotonic liquid, softening the tape.
- In the first stage, a nurse and a specialist doctor who are independent of the study will evaluate the skin damage caused by the removal of intravenous vascular access in preterm newborns by using the "Neonatal Skin Condition Assessment Scale" by the observers, and the score will be given and recorded.
- Alcohol-free cotton wipes dipped in water will be used to clean the damaged skin area of newborns in both groups.
- Preterm newborns will be randomly assigned to 2 groups as breast milk and routine care group.
Second Stage;
Breast Milk Group:
For skin damage care of preterm newborns who are randomly assigned to the breast milk group, their own breast milk will be applied topically once in 60 minutes until complete healing. A decrease of at least 1 point in the 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 (Qu-Yang et al., 2013; Rosali et al., 2015; Rodrigues et al., 2017).
Routine Care Group:
For skin damage care of preterm newborns who are randomly assigned to the cream group, the cream will be applied topically once in 60 minutes until complete healing. A reduction of 1 point 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.
In both groups, skin damage will be evaluated once before the procedure and 10 times after the procedure (with an interval of one hour), a total of 11 times.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| humanmilk | Experimental | Other: human milkFor 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. |
| routine care group | Experimental | Other: Routine care groupcream applied as part of hospital routine practice |
Who may qualify
- Ages
- 1 day to 30 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (13 listed)
- 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,
Key exclusion criteria (12 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| human milkFor 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 | humanmilk |
| Routine care groupcream applied as part of hospital routine practice | Other | routine care group |
Primary outcome
skin damage
Time frame: 3 weeks
The change in skin damage after the intervention with newborn skin condition assessment scalewill be monitored.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing human milk and Routine care group in people with Milk Expression, Breast, run by Karamanoğlu Mehmetbey University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
skin damage (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2023.