Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT04972747 |
| Other study ID # |
2020/124-2 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 16, 2020 |
| Est. completion date |
July 30, 2022 |
Study information
| Verified date |
March 2022 |
| Source |
Derince Training and Research Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
As a result of technological advances in the field of newborns, the survival rates of very
young babies have increased. With this situation, there was a need to develop new
evidence-based application areas in premature babies. Nurses provide evidence-based care in
many areas to term and preterm babies in the neonatal intensive care unit. One of these areas
is the skin, which is known as 13% of the newborn's body weight and constitutes the largest
part of the organism. Before skin care is given, knowing the skin characteristics of the
newborn and performing skin care in accordance with these features will provide more benefits
for the baby. The skin of newborns is different from adults in terms of both function and
function. In addition, skin characteristics of term and preterm babies also differ according
to the week of delivery.
Skin basically enables the newborn to explore the world by thermoregulation, as a barrier
against microorganisms and chemical harmful substances, maintaining fluid-electrolyte
balance, vitamin D production, fat storage and sensory-touch. The immature skin of the
newborn cannot fully fulfill these functions. In another study conducted between sunflower
oil and the control group, it was stated that rash and peeling were less common in the
sunflower oil experiment group compared to the control group.
As a result, evidence-based knowledge of nurses about neonatal skin care should be increased
in neonatal intensive care units, and appropriate nursing care should be given especially to
premature newborns who are at risk due to hospitalization. Even if there is no routine
procedure in our service, baby oil is massaged during care hours, but there is no study on
this. The aim of this study is to contribute to the neonatal skin care literature and to
provide appropriate evidence-based care in the service routine.
Description:
The research will be carried out with preterm babies hospitalized in the 3rd Level Neonatal
Intensive Care Unit of SBÜ Kocaeli Derince Training and Research Hospital, Alikahya Campus
and meeting the criteria of the study. Preterm babies with a birth weight of 1000 g and
above, who do not receive ventilator support, and who do not have skin damage more than 5% of
the body surface between 32-36 weeks of gestation will be included in the study. Two groups
will be created by randomization method.
These groups are; Sunflower oil group: Babies to whom skin care will be applied with
sunflower oil.
Coconut oil group: Babies who will be treated with coconut oil
After the premature babies who meet the study criteria are divided into groups and their
consent is obtained, they will be followed up by the person conducting the study, and all
applications will be carried out by the same person. Information about the newborn will be
filled in by the person who will perform the application by using the "Form for Identifying
the Introductory and Clinical Characteristics of the Newborn".
The application will be carried out twice a day during the maintenance hours of the service.
In skin care applications, body baths are applied not more than three times a week, as it may
cause hypothermia in preterm babies in the ward routine. In daily skin care, body cleaning
with cotton, changing the fixation points such as orogastric probe, and changing the monitor
probe locations are among the routine practices. In order to hydrate and moisturize the skin
in preterm and term babies, baby oil in the service is used. Skin care applied in the service
routine will be applied to the preterm babies included in the study, and only sunflower oil
and coconut oil will be used as moisturizers.
APPLICATION Group 1: Preterm babies treated with sunflower oil
- 31 preterm babies determined by randomization method will be included in the group to be
applied skin care with sunflower oil.
- Before the application, the researcher will meet with the family and fill in the
"Informed Consent Form".
- Social hand washing will be applied before the application.
- Before the application, the skin of the newborn will be evaluated by using the "Neonatal
Skin Condition Assessment Scale".
- In order to measure the moisture of the skin before the application, the moisture level
of the skin will be recorded by measuring from three different points, namely the
abdomen, legs and arms, with a DMM branded skin moisture meter.
- The baby will be placed under a radiant warmer by the practitioner to keep his body
temperature.
- For the follow-up of growth parameters, the weight of the newborn will be weighed at the
same time while the baby is naked, using the digital baby scale in the service. In
addition, the baby's head circumference, height and belly circumference will be measured
with a tape measure and recorded.
- Before each application, preterm babies will be given skin care in the service routine
and sunflower oil will be applied twice a day for 14 days.
- Absorption of sunflower oil for preterm babies will be provided by using a baby massage
application.
- Before the massage, 3-4 ml of sunflower oil will be applied to the whole body surface
except the genital area and scalp.
- Massage to the baby will be started first on the legs and feet, then continued with
massage of the abdomen and chest area, arms and hands, face and back, respectively, and
will be applied for 15 minutes at least 30 minutes after feeding.
- 12 hours after each application, the skin of the newborn will be evaluated using the
"Neonatal Skin Condition Assessment Scale", and the measurement will be made with a DMM
brand skin moisture meter and recorded in the follow-up form.
- Weight monitoring will be recorded daily to monitor growth parameters and daily weight
gain / decrease will be monitored. Head circumference and height lengths will be
measured and recorded before the application and on the 7th and 14th day of the
application.
Group 2: Preterm babies treated with coconut oil
- 31 preterm coconut oils determined by randomization method will be included in the group
to be applied skin care.
- Before the application, the researcher will meet with the family and fill in the
"Informed Consent Form".
- Social hand washing will be applied before the application.
- Before the application, the skin of the newborn will be evaluated by using the "Neonatal
Skin Condition Assessment Scale".
- In order to measure the moisture of the skin before the application, the moisture level
of the skin will be recorded by measuring from three different points, namely the
abdomen, legs and arms, with a DMM branded skin moisture meter.
- The baby will be placed under a radiant warmer by the practitioner to keep his body
temperature.
- For the follow-up of growth parameters, the weight of the newborn will be weighed at the
same time while the baby is naked, using the digital baby scale in the service. In
addition, the baby's head circumference, height and belly circumference will be measured
with a tape measure and recorded.
- Before each application, preterm babies will be given skin care in the service routine
and coconut oil will be applied twice a day for 14 days.
- Absorption of coconut oil for preterm babies will be provided by using a baby massage
application.
- Before the massage, 3-4 ml of coconut oil will be applied to the whole body surface
except the genital area and scalp.
- Massage to the baby will be started first on the legs and feet, then continued with
massage of the abdomen and chest area, arms and hands, face and back, respectively, and
will be applied for 15 minutes at least 30 minutes after feeding.
- 12 hours after each application, the skin of the newborn will be evaluated using the
"Neonatal Skin Condition Assessment Scale", and the measurement will be made with a DMM
brand skin moisture meter and recorded in the follow-up form.
- Weight monitoring will be recorded daily to monitor growth parameters and daily weight
gain / decrease will be monitored. Head circumference and height lengths will be
measured and recorded before the application and on the 7th and 14th day of the
application.
Sunflower oil
Sunflower oil is a light yellow colored and light-tasting vegetable oil obtained from the
seeds of the sunflower plant. It contains 90% unsaturated fatty acids (combined oleic and
linoleic) and about 10% saturated fatty acids (palmitic and stearic). In the literature, the
importance of using mineral oils in maintaining the integrity of the skin of newborns has
been stated and there are many studies using sunflower oil on this subject.
Coconut Oil
Coconut oil is a highly saturated fat traditionally made from the oil's raw coconut or dried
coconut kernels. Coconut oil is rich in medium-chain fatty acids, a saturated form of fat. It
contains Lauric acid 49%, Mystic acid 18%, Caprylic acid 8%, Palmitic acid 8% and Capric acid
7%.
Recruitment Criteria;
- Parents' consent to participate in the research
- Preterm babies at 32-36 gestational week
- preterm babies with a weight of 1000 gr and above
- Non-surgical infants are included
Exclusion Criteria;
- Preterm babies monitored on mechanical ventilation
- Skin damage over 5% of the body surface
- Preterm babies receiving phototherapy
