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Completed

NCT Number: NCT06242340

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

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.

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Key information

Conditions

Age range

32 week–38 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karadeniz Technical University Health Application and Research Center Farabi Hospital

Trabzon, 61080, Turkey (Türkiye)

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Preterm group bathing 24 hours after birth.

Other

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.

Preterm group bathing 48 hours after birth.

Other

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.

Early term group bathing 24 hours after birth.

Other

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.

Early term group bathing 48 hours after birth.

Other

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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,

  4. 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.

Sponsors and collaborators

Lead sponsor

Karadeniz Technical University

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Feb 5, 2024
Registry last updated
Feb 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.