Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05390372 |
| Other study ID # |
Humanmilk |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 1, 2022 |
| Est. completion date |
November 1, 2022 |
Study information
| Verified date |
March 2023 |
| Source |
Karamanoglu Mehmetbey University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
