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

February 2, 2024 updated by: İlknur KAHRİMAN, Karadeniz Technical University

The aim of this study is to examine the effect of the first bath timing after birth on the physiological variables of the newborn and to determine the correct bath time.

  1. H₁: There is a difference in the effect of bathing preterm newborns after 24 hours or 48 hours on the peak heart rate.
  2. H2: There is a difference in the effect of bathing early term newborns after 24 hours or 48 hours on the peak heart rate.
  3. H3: There is a difference in the effect of bathing preterm newborns after 24 hours or 48 hours on their respiratory rate.
  4. H4: There is a difference in the effect of bathing early term newborns after 24 hours or 48 hours on their respiratory rate.
  5. H5: There is a difference in the effect of baths given to preterm newborns after 24 hours or 48 hours on body temperature.
  6. H6: There is a difference in the effect of baths given to early term newborns after 24 hours or after 48 hours on body temperature.
  7. H7: There is a difference in the effect of baths given to preterm newborns after 24 hours or 48 hours on oxygen saturation.
  8. H8: There is a difference in the effect of baths given to early term newborns after 24 hours or after 48 hours on oxygen saturation.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The aim of this study is to examine the effect of the first bath timing after birth on the physiological variables of the newborn and to determine the correct bath time. The research is a single-center, prospective parallel group randomized controlled experimental design study. The research was conducted with a total of 120 babies, 60 preterm babies and 60 early term babies, who received inpatient care and treatment in the neonatal intensive care unit between October 2022 and November 2023. Depending on randomization, newborns were bathed within 24 hours or 48 hours after birth. Physiological measurements of newborns were evaluated before application. Measurements were repeated after application, 10 minutes after application and 60 minutes after application. In the study, it was collected with the Baby Information Form and Physiological Variables Monitoring Form. Data were analyzed using chi-square, mean, percentage distributions, dependent groups t-test for comparison of intra-group measurements, repeated measures anova test, and independent groups t-test for comparison of quantitative continuous data. In the preterm group, the pre-bath respiration, body temperature and oxygen saturation values of newborns bathed within 48 hours were found to be significantly lower than those of newborns bathed within 24 hours in post-bath measurements (p<0.05). In the early term group, it was found that the pre-bath heart rate peak values of newborns bathed within 48 hours were significantly lower than those of newborns bathed within 24 hours in post-bath measurements (p<0.05).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Trabzon, Turkey, 61080
        • Karadeniz Technical University Health Application and Research Center Farabi Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Newborns should be between 32 0/7 and 38 6/7 weeks.
  • Birth weight must be over 2000 grams.
  • He should not be connected to a mechanical ventilator.
  • The parent must agree to work.

Exclusion Criteria:

  • Less than 32 0/7 weeks.
  • 39 0/7 weeks over.
  • Being connected to a mechanical ventilator.
  • Lacking epidermal integrity.
  • Having an infection.
  • Babies with anomalies and syndromes.
  • Whose mother has an infection (hepatitis B, hepatitis C, HIV).
  • Having phototherapy treatment.
  • Having a body temperature below 36.5 °C.
  • Having a body temperature above 37.5 ºC.
  • Feeding within an hour before bathing.
  • A painful procedure is performed within thirty minutes before bathing.
  • Taking sedative medication.
  • Those whose parents do not allow them to work.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group 1
Preterm (between 32 0/7 and 36 6/7 weeks)
Other: Preterm group bathing 24 hours after birth.
Preterm (between 32 0/7 and 36 6/7 weeks) babies (n=30) were bathed in the form of a shower 24 hours after birth. Before the bath, after the bath, 10 minutes after the bath and 60 minutes after the bath, heart rate, body temperature, respiratory rate, oxygen saturation value, and skin color were evaluated.
Experimental: Group 2
Preterm (between 32 0/7 and 36 6/7 weeks)
Other: Preterm group bathing 48 hours after birth.
Preterm (between 32 0/7 and 36 6/7 weeks) babies (n=30) were bathed in the form of a shower 48 hours after birth. Before the bath, after the bath, 10 minutes after the bath and 60 minutes after the bath, heart rate, body temperature, respiratory rate, oxygen saturation value, and skin color were evaluated.
Experimental: Group 3
Early term (between 37 0/7 and 38 6/7 weeks)
Other: Early term group bathing 24 hours after birth.
Early term (between 37 0/7 and 38 6/7 weeks) babies (n=30) were bathed in the form of a shower 24 hours after birth. Before the bath, after the bath, 10 minutes after the bath and 60 minutes after the bath, heart rate, body temperature, respiratory rate, oxygen saturation value, and skin color were evaluated.
Experimental: Group 4
Early term (between 37 0/7 and 38 6/7 weeks)
Other: Early term group bathing 48 hours after birth.
Early term (between 37 0/7 and 38 6/7 weeks) babies (n=30) were bathed in the form of a shower 48 hours after birth. Before the bath, after the bath, 10 minutes after the bath and 60 minutes after the bath, heart rate, body temperature, respiratory rate, oxygen saturation value, and skin color were evaluated.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Body temperature
Time Frame: It was evaluated at 1 minute before bath, after bath, 10 minutes after bath and 60 minutes after bath.
Body temperature will be recorded and evaluated in degrees Celsius.
It was evaluated at 1 minute before bath, after bath, 10 minutes after bath and 60 minutes after bath.
Respiratory rate
Time Frame: It was evaluated at 1 minute before bath, after bath, 10 minutes after bath and 60 minutes after bath.
Respiration will be recorded and evaluated in numbers by counting for 1 minute by the researcher.
It was evaluated at 1 minute before bath, after bath, 10 minutes after bath and 60 minutes after bath.
Heart rate
Time Frame: It was evaluated at 1 minute before bath, after bath, 10 minutes after bath and 60 minutes after bath.
Heart rate will be recorded and evaluated in numbers by measuring with a monitor,
It was evaluated at 1 minute before bath, after bath, 10 minutes after bath and 60 minutes after bath.
Oxygen saturation value
Time Frame: It was evaluated at 1 minute before bath, after bath, 10 minutes after bath and 60 minutes after bath.
Oxygen saturation value will be recorded and evaluated in numbers by the monitor.
It was evaluated at 1 minute before bath, after bath, 10 minutes after bath and 60 minutes after bath.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Karadeniz Technical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 18, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 20, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 20, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 25, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 5, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 5, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KARADENIZTEKNIK

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.

IPD Sharing Time Frame

12 months after publication

IPD Sharing Access Criteria

Relevance to the topic of the study and approval of all co-authors within 1 month of receiving the request.

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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