Delaying First Bathing and Skin Barrier Function on Infant

NCT04231799 | Completed DMC

• 1 other identifier: KAEK-30
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Premature; Thermoregulation

Keywords

First Bathing; TEWL; Neonatal intensive care unit; Nursing care; Premature infant; Skin care; Comfort

Outcome Measures

Primary Outcomes (1)

• 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.

  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 Outcomes (2)

• Comfort

  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.

• Body temperature

  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.

Study Arms (2)

Bathing within 24-48

EXPERIMENTAL

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

Procedure: Bathing

Bathing within 48-72

EXPERIMENTAL

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

Procedure: Bathing

Interventions

Bathing 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 24-48; Bathing within 48-72

Eligibility Criteria

• Age: 24 Hours - 72 Hours
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Akdeniz University: lead

Study Sites (1)

Akdeniz Universty

Antalya, 07000, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 31442786 BACKGROUND

• 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.

  PMID: 33210328 DERIVED

MeSH Terms

Conditions

Premature Birth

Interventions

Baths

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Balneology; Therapeutics

Study Officials

• Emine EFE

  Akdeniz University Children's Health and the Nursing Department

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized controlled multicenter double blind trial

Study Record Dates

• First Submitted: January 9, 2020
• First Posted: January 18, 2020
• Study Start: February 20, 2020
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2022
• Last Updated: October 3, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)