Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04231799
Study type Interventional
Source Akdeniz University
Contact
Status Completed
Phase N/A
Start date February 20, 2020
Completion date September 1, 2022

See also
  Status Clinical Trial Phase
Not yet recruiting NCT04067973 - Impact of Prematurity on the Optic Nerve
Recruiting NCT05968586 - Non-Invasive Neurally Adjusted Ventilatory Assist (NAVA) Prone vs Supine in Premature Infants N/A
Not yet recruiting NCT05706584 - The Effect of Metaverse-Based Nursing Skills Laboratory N/A
Not yet recruiting NCT05530733 - Clinical Effects of Pacifier Use in Preterm During Orogastric Tube Feeding N/A
Withdrawn NCT04561700 - Nutritive Sucking Patterns in Premature Infants N/A
Recruiting NCT01443273 - Thrombophilic Risk Factors in Preterm and Infants Treated at Ha'Emek Medical Center Between the Years 1990 to 2010
Recruiting NCT04565210 - Effects of Oriental Music on Preterm Infants N/A
Not yet recruiting NCT06072625 - Enteral Feeding of Premature Babies and Olive Oil Supplementation N/A
Recruiting NCT04866342 - Servo Controlled Oxygen Targeting (SCO2T) Study: Masimo vs. Nellcor N/A
Enrolling by invitation NCT04168749 - Efficacy and Safety of Industrially Prepared 3 Chamber Bag Parenteral Nutrition for Premature Infant
Recruiting NCT04458441 - Can Warm Skin Disinfection Reduce the Pain Peripheral Central Catheter Application in Premature Babies? N/A
Recruiting NCT05835817 - Magnetoencephalography by Optical Pumping Magnetometer N/A
Enrolling by invitation NCT03061968 - Study of Applying Acupressure in Low-birth Weight Premature N/A
Recruiting NCT06207071 - Early DHA/ARA Supplementation in Growth-restricted Very Preterm Infants: A Randomized Clinical Trial N/A
Not yet recruiting NCT05806684 - Hyperbilirubinemia and Retinopathy of Prematurity in Preterm Infants: a Retrospective Study.
Recruiting NCT05380401 - Metabolic Mechanisms Induced by Enteral DHA and ARA Supplementation in Preterm Infants N/A
Completed NCT04298346 - Neurological Fate, Prematurity and Genetic Susceptibility Factors
Active, not recruiting NCT05343403 - Parental Participation on the Neonatal Ward - the neoPARTNER Study
Completed NCT04035564 - Early Sodium Intake in Preterm Newborns Phase 4
Recruiting NCT04432636 - Gut Bacteria and Brain of the Baby N/A