Delaying First Bathing and Skin Barrier Function on Infant (TEWL)
Primary Purpose
Premature, Thermoregulation
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Bathing
Sponsored by

About this trial
This is an interventional supportive care trial for Premature focused on measuring First Bathing, TEWL, Neonatal intensive care unit, Nursing care, Premature infant, Skin care, Comfort
Eligibility Criteria
Inclusion Criteria:
- Born between 34 weeks + 0 days and 36 weeks + 6 days (late preterms),
- With a body weight of over 2000g,
- Spontaneous breathing,
- Preterms with stable physiological parameters
Exclusion Criteria:
- Receiving mechanical ventilation support,
- HIV, Hepatitis B mother baby,
- Preterms bathed before the intervention,
- Surgical procedure and incision in any region,
- Preterms with central catheters,
- Preterms with systemic infection,
- Preterms using sedative and / or muscle relaxants,
- Preterms with congenital, chromosomal abnormalities
Sites / Locations
- Akdeniz Universty
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Bathing within 24-48
Bathing within 48-72
Arm Description
Participants who will have their first bath in 24-48th hours after birth.
Participants who will have their first bath in 48-72th hours after birth.
Outcomes
Primary Outcome Measures
Skin Barrier Function
Transepidermal water loss of the participants will be measured using the VapoMeter SWL-2 ™ (Delfin Technologies Ltd). The skin barrier function of the participants will be evaluated in this way.
Secondary Outcome Measures
Comfort
The ComfortNeo scale will be used to measure newborns' comfort. The ComfortNeo is a Likert-type scale consisting of six parameters: alertness, calmness/agitation, crying, body movement, facial tension, and (body) muscle tone. The lowest score that can be obtained using this scale is 6, and the highest score is 30. Scores in the range of 6 to 13 indicate that the newborn is comfortable, while scores 14-30 are indicative of pain or distress in the newborn, thus necessitating comforting.
Body temperature
Axillary body temperature of infants
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04231799
Brief Title
Delaying First Bathing and Skin Barrier Function on Infant
Acronym
TEWL
Official Title
The Effect of Delayed First Bathing on Skin Barrier Function, Body Temperature and Comfort in Late Preterm Infants
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
February 20, 2020 (Actual)
Primary Completion Date
September 1, 2021 (Actual)
Study Completion Date
September 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Akdeniz University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
It is still unknown when the first bath should be done in premature newborns. Investigators think that delaying the time of the first bath compared to the time in the clinic will show some positive changes in preterm newborns.
Detailed Description
Bath procedures and timing to reduce neonatal stress and protect the skin barrier should be preferred. This study aims to investigate the effect of delaying the first bath on skin barrier function, comfort and body temperature in late preterm infants. The study, between March 2020 and March 2021 in Turkey / Antalya will be held in three central provinces in the Neonatal Intensive Care Unit. Skincare is routinely performed between 08.00 and 09.00 in the form of a tub bath. This study sampled 80 stable, late preterm infants who were cared for in the NICU. This example was considered to be sufficient based on a sample size calculation in PS Power and Sample Size Calculations (Version 3.0). Allocations about the allocation were provided only by the lead researcher. Participants were given a sequential number placed in an opaque, closed envelope by the researcher who received the signed parental informed consent. When the participant is planned to take a bath, the researcher will be blind. The researcher who will apply the bathing process will not know the postnatal age of the baby when bathing. And the outcome evaluation of the participants was blinded. The participants were randomly divided into two groups. The bath will be applied to one group within the first 48 hours and the other group within 48-72 hours. The participants will then be placed in a preheated incubator that varies according to the weight and age of the participant. To compensate for such differences, the heads of all participants will be placed at a height of 30 degrees in the right lateral position after bathing. After the bath, participants were left without intervention or contact for about 10 minutes or until they settled before being evaluated. The participant Baths Work Record, a data collection tool, was designed specifically for this study. The instrument includes a series of scales for measuring outcome variables and demographic information (age, sex, mode of delivery, gestational age, birth weight, bodyweight at work, etc.). Outcome measurements include transepidermal water loss for skin barrier function, neonatal comfort behavior, and body temperature. Those responsible for data collection will be blinded in the allocation of the participants they evaluate. The ComfortNeo scale will be used to measure the comfort and pain intensity of newborns. The outcome criteria will be evaluated in three separate cases (10 minutes before bath, 1 minute and 10 minutes after bath). SPSS 20.0 and SAS (ver. 9.3) will be used and statistical significance will be set to p <0.05.
The data will be presented as means and standard deviations for continuous variables and as frequencies for categorical variables. For participant characteristics such as birth type and gender, the chi-square test will be used to determine whether there is a significant difference between the groups. Participant characteristics such as birth weight and body weight during the study will be evaluated for significant intergroup differences using a one-way ANOVA test. In order to compare different phases, the measurement parameters (comfort score, body temperature) in the baths will be averaged separately. To analyze both intra-group and intra-group differences, repeated variance analysis followed by Bonferroni's post hoc test.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature, Thermoregulation
Keywords
First Bathing, TEWL, Neonatal intensive care unit, Nursing care, Premature infant, Skin care, Comfort
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled multicenter double blind trial
Masking
Care ProviderOutcomes Assessor
Masking Description
The person who will bathe the baby will not know the postnatal age of the baby. he will not know at what time of birth the baby's first bath is applied.
The two assessors who will measure the results will not know the postnatal age of the baby and in which group.
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bathing within 24-48
Arm Type
Experimental
Arm Description
Participants who will have their first bath in 24-48th hours after birth.
Arm Title
Bathing within 48-72
Arm Type
Experimental
Arm Description
Participants who will have their first bath in 48-72th hours after birth.
Intervention Type
Procedure
Intervention Name(s)
Bathing
Intervention Description
Traditionally, it is the process of washing the newborn in the first hours of life to remove blood, meconium, varnish and other infectious substances.
Primary Outcome Measure Information:
Title
Skin Barrier Function
Description
Transepidermal water loss of the participants will be measured using the VapoMeter SWL-2 ™ (Delfin Technologies Ltd). The skin barrier function of the participants will be evaluated in this way.
Time Frame
The Skin Barrier Function will be carried out by measuring trans epidermal water loss 10 minutes before first bath and 10 minutes after first bath.
Secondary Outcome Measure Information:
Title
Comfort
Description
The ComfortNeo scale will be used to measure newborns' comfort. The ComfortNeo is a Likert-type scale consisting of six parameters: alertness, calmness/agitation, crying, body movement, facial tension, and (body) muscle tone. The lowest score that can be obtained using this scale is 6, and the highest score is 30. Scores in the range of 6 to 13 indicate that the newborn is comfortable, while scores 14-30 are indicative of pain or distress in the newborn, thus necessitating comforting.
Time Frame
The comfort will be carried out by ComfortNeo scale 10 minutes before first bath, 1 minutes after first bath and 10 minutes after first bath.
Title
Body temperature
Description
Axillary body temperature of infants
Time Frame
The body temperature will be measured by digital thermometers 10 minutes before first bath, 1 minutes after first bath and 10 minutes after first bath.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
24 Hours
Maximum Age & Unit of Time
72 Hours
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Born between 34 weeks + 0 days and 36 weeks + 6 days (late preterms),
With a body weight of over 2000g,
Spontaneous breathing,
Preterms with stable physiological parameters
Exclusion Criteria:
Receiving mechanical ventilation support,
HIV, Hepatitis B mother baby,
Preterms bathed before the intervention,
Surgical procedure and incision in any region,
Preterms with central catheters,
Preterms with systemic infection,
Preterms using sedative and / or muscle relaxants,
Preterms with congenital, chromosomal abnormalities
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emine EFE
Organizational Affiliation
Akdeniz University Children's Health and the Nursing Department
Official's Role
Study Director
Facility Information:
Facility Name
Akdeniz Universty
City
Antalya
ZIP/Postal Code
07000
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
It is not yet decided. After the study was finalized, the decision was planned.
Citations:
PubMed Identifier
31442786
Citation
Tasdemir HI, Efe E. The effect of tub bathing and sponge bathing on neonatal comfort and physiological parameters in late preterm infants: A randomized controlled trial. Int J Nurs Stud. 2019 Nov;99:103377. doi: 10.1016/j.ijnurstu.2019.06.008. Epub 2019 Jun 21.
Results Reference
background
PubMed Identifier
33210328
Citation
Tasdemir HI, Efe E. The effect of delaying first bathing on skin barrier function in late preterm infants: A study protocol for multi-centre, single-blind RCT. J Adv Nurs. 2021 Feb;77(2):1051-1061. doi: 10.1111/jan.14657. Epub 2020 Nov 18.
Results Reference
derived
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Delaying First Bathing and Skin Barrier Function on Infant
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