Clinical trial NCT05083234: Maintaining Skin Integrity in Neonates With Sunflower Seed Oil and Liquid Vaseline
Official title: Maintaining Skin Integrity in Neonates With Sunflower Seed Oil and Liquid Vaseline: A Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neonatal Skin Conditions
Nursing Caries
Keywords: neonate
neonatal skin care
neonatal skin condition score
sunflower seed oil
liquid vaseline
Lead sponsor: Maltepe University
Sponsor class: OTHER
First posted: 2021-10-19
Enrollment: 90
Sex: ALL
Minimum age (years): 32
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assigment,
Primary purpose: SUPPORTIVE_CARE

Brief summary: In this randomized controlled study, 90 preterm and term neonates in the NICU of a state hospital were equally divided into 3 groups. The skin integrity of the newborns in all three groups was assessed in terms of the Neonatal Skin Condition Score (NSCS), which was performed a total of 9 times at 48-hour intervals. The skin of the newborns in the first group was moisturized with SSO and with LV in the second group, once a day, a total of 17 times. Moisturizer was not applied to the skin of the third group of newborns (the control group).

Detailed description: Because the barrier function of the skin of the newborn is still immature, disruption of skin integrity is a commonly observed problem. The purpose of the study was to test the applicability and effectiveness of sunflower seed oil (SSO) and Liquid Vaseline (LV) in maintaining skin integrity in term and preterm neonates in the Neonatal Intensive Care Unit (NICU). The sample size of the study has been determined by the power analysis (G\*Power 3.1.9.2), The sample size was found to be a total of 66 neonates including minimum of 22 neonates for each group. It was estimated that case losses may occur and therefore, it was decided to conduct the study with a total of 90 neonates including 30 neonates in three groups. Assignment of neonates to research groups was done according to the order of hospitalization in the NICU. The first hospitalized neonates SSO, the second hospitalized LV, and the third hospitalized were included in the control group. The groups were repeated until they were complete. Weighing the neonate, taking vital signs, evaluating the skin condition, wiping the whole body, and stabilizing the general condition of the neonate before moisturizing the skin were taken into account. Neonates Information Form(NIF) and Neonatal Skin Condition Score (NSCS) were used for data collection. Parents of neonates were informed about the study. First day of hospitalization; Demographic data and medical history of the neonate in the study or control group were obtained from the patient file records. The neonate was weighed, vital signs were taken, and the data were recorded in the NIF.

The body of all neonates in the research or control group was wiped on the 1st day of hospitalization. In the following days, it was repeated 2 times a week (Monday and Friday) in the same way.The skin condition of the neonate in the research or control group was evaluated with the NSCS scale. The first skin evaluation was performed on the 1st day of hospitalization (1st NSCS). Skin condition was re-evaluated at 48 hour intervals in the following days. Skin condition of the neonate in the control or research group was evaluated a total of 9 times with 48-hour intervals. After the initial skin condition assessment, the neonate's skin is moistened with SSO or LV, depending on the group. It was rehydrated once a day (24 hours apart) in the following days.

Eligibility criteria: Inclusion Criteria:

* Parents giving verbal and written consent,
* Hospitalized in the NICU within the first 24 hours after birth,
* With a birth weight of more than 1500 g,
* No life-threatening health problems and skin diseases.

Exclusion Criteria:

* Gestational age less than 32 weeks,
* Parents who do not give verbal and written permission,
* Hospitalized in the NICU after the first 24 hours after birth,
* With a birth weight of less than 1500 g,
* Having life-threatening health problems and skin diseases.

Primary outcomes:
measure: Skin condition score of newborns
timeFrame: Change from skin condition score of newborns at 16 days
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Kanuni Sultan Süleyman Research and Training Hospital NICU
state: Küçükçekmece
Study officials:
affiliation: Maltepe University School of Nursing
name: Behice Ekici, PhD
role: STUDY_DIRECTOR
References: