Delaying First Bathing and Skin Barrier Function on Infant

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-20

Study Completion Date

2022-09-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Effect of Newborn's First Bath Time on Physiological Variables

NCT06242340

Baths

COMPLETED NA

The Effect of Tub vs Sponge Bathing on the Comfort of Premature Infants

NCT03796312

Preterm Infant Premature Birth

COMPLETED NA

Management and Thermal Comfort of Premature Infants Under 32 Weeks

NCT03648606

Thermoregulation

COMPLETED

Effect of a Bathing Care Package on Comfort and Skin Moisture in Preterm Infants in a Neonatal Intensive Care Unit

NCT07068737

Preterm Birth Skin Hydration in Preterm Infants Comfort in Neonates +2 more

COMPLETED NA

Air vs. Cutaneous Control Mode for Preterm Infants ≤ 32 WG in Incubators: Impact on Body Growth and Morbidity

NCT03919188

Preterm Infant Body Temperature

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Premature Thermoregulation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled multicenter double blind trial

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Bathing within 24-48

Participants who will have their first bath in 24-48th hours after birth.

Group Type EXPERIMENTAL

Bathing

Intervention Type PROCEDURE

Traditionally, it is the process of washing the newborn in the first hours of life to remove blood, meconium, varnish and other infectious substances.

Bathing within 48-72

Participants who will have their first bath in 48-72th hours after birth.

Group Type EXPERIMENTAL

Bathing

Intervention Type PROCEDURE

Traditionally, it is the process of washing the newborn in the first hours of life to remove blood, meconium, varnish and other infectious substances.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Bathing

Traditionally, it is the process of washing the newborn in the first hours of life to remove blood, meconium, varnish and other infectious substances.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

24 Hours

Maximum Eligible Age

72 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes