NCT04972747

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 16, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 20, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 22, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2022

Completed
Last Updated

March 22, 2022

Status Verified

March 1, 2022

Enrollment Period

7 months

First QC Date

May 20, 2021

Last Update Submit

March 21, 2022

Conditions

Keywords

skin carepretermcoconut oilsunflowers oilgrowth parameter

Outcome Measures

Primary Outcomes (1)

  • The effect of skin care applied with two different oils on skin integrity and growth parameters in premature babies

    Neonatal Skin Condition Score-NSCS. The scale consists of three parameters. These; dryness, redness and deterioration of skin integrity/peeling. Each parameter is scored from one to three. The lowest score that can be obtained from the scale is 3, the highest score is 9, and a total score of 16 indicates that the skin condition of the newborn is poor.

    one year

Study Arms (2)

Suggest skin care with sunflower oil for preterm babies

EXPERIMENTAL

* 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.. * 12 hours after each application, the skin of the newborn will be evaluated using the "Neonatal Skin Condition Assessment Scale" (Appendix-2), and the measurement will be made with a DMM brand skin moisture meter and recorded in the follow-up form.

Other: skin care with sunflower oil

Suggest skin care with cocunut oil for preterm babies

EXPERIMENTAL

* 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. * 12 hours after each application, the skin of the newborn will be evaluated using the "Neonatal Skin Condition Assessment Scale" (Appendix-2), and the measurement will be made with a DMM brand skin moisture meter and recorded in the follow-up form.

Other: skin care with sunflower oil

Interventions

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.

Also known as: skin care with coconut oil
Suggest skin care with cocunut oil for preterm babiesSuggest skin care with sunflower oil for preterm babies

Eligibility Criteria

Age2 Days - 30 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Parents' agreement to participate in the research
  • Preterm babies at 32-36 gestational week
  • gr and above preterm babies
  • Non-surgical infants are included.

You may not qualify if:

  • Skin damage may occur over 5% of the body surface
  • Preterm babies monitored on mechanical ventilation
  • Preterm babies receiving phototherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Derince eğitim ve Araştırma Hastanesi

Kocaeli, İ̇zmi̇t, 41000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Skin CareSunflower OilCoconut Oil

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

HygieneTherapeuticsPlant OilsPlant PreparationsBiological ProductsComplex MixturesDietary FatsFatsLipidsOils

Study Officials

  • Gülzade Uysal, assoc. prof

    Okan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
Babies meeting the criteria will be divided into two groups by randomization method. Randomization will be done by drawing lots using two red and blue cards. 31 red and 31 blue cards will be placed in an invisible purse. For the baby who meets the criteria, a card will be drawn by another nurse working in the clinic. Massage with sunflower oil will be applied for the baby with a red card, and skin care with coconut oil will be applied for the baby with a blue card.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: randomized controlled clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 20, 2021

First Posted

July 22, 2021

Study Start

October 16, 2020

Primary Completion

May 20, 2021

Study Completion

July 30, 2022

Last Updated

March 22, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations