NCT03796312: ComfortNEO

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

Completed NA Last updated 8 January 2019

What this trial tests

NA trial testing Tub Bathing in Preterm Infant in 120 participants. Completed in 29 November 2016.

Timeline

20 November 2015

Primary endpoint
29 November 2016

29 November 2016

Quick facts

Lead sponsor	Akdeniz University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	supportive care
Enrollment	120
Start date	20 November 2015
Primary completion	29 November 2016
Estimated completion	29 November 2016
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• Tub Bathing
• Sponge Bathing

Conditions studied

• Preterm Infant — all drugs for Preterm Infant →
• Premature Birth — all drugs for Premature Birth →

Sponsor

Akdeniz University

Who can join

Adults 34 Weeks to 36 Weeks, any sex, with Preterm Infant or Premature Birth. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The integumentary system protects the underlying body from the external environment, such as shocks, temperature, ultraviolet radiation, chemicals, and other threats. There is a considerable body of clinical evidence highlighting the importance of the stratum corneum and its barrier functions, which are especially beneficial for newborns. Given the dramatic transition from the aqueous womb to the dry terrestrial environment at birth, studies describing adaptations made by the skin barrier within the first month of life assume greater importance. The skin of the baby is morphologically and functionally different from the skin of adults. Neonatal skin is thinner, more fragile, and drier than adult skin; it is difficult to maintain fluid-electrolyte balance and temperature regulation. Notwithstanding, structure and function of skin continues to improve during the first months and even years of life. Special care procedures are nonetheless necessary to ensure healthy development, to protect the skin from irritation and reddening, and to help the newborn feel well. Therefore, this study, taking the form of a randomized controlled trial, aims to examine the effectiveness of tub bathing and sponge bathing on the physiological parameters (heart rate, respiration rate, oxygen saturation, body temperature) and comfort of late preterm infants. Increasing comfort and physiological stabilization in premature infants during neonatal care improves their neurophysiological development. Bathing procedures that support this development and will not expose the newborn to stress should be preferred.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The effect of tub bathing and sponge bathing on neonatal comfort and physiological parameters in late preterm infants: A randomized controlled trial.
   Taşdemir Hİ, Efe E. · · 2019 · cited 19× · PMID 31442786 · DOI 10.1016/j.ijnurstu.2019.06.008