NCT05097495

Non-Nutritive Sucking vs Non-Nutritive Sucking Combined With Breast Milk on the Neonatal Comfort

The Effect of the Use of Non-Nutritive Sucking vs Non-Nutritive Sucking Combined With Breast Milk on the Neonatal Comfort During Diaper Change in Preterm Infants

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Acibadem University · Academic / Other
• Sex: All
• Age: 1 Day – 28 Days
• Healthy volunteers: Not accepted

Summary

The aim of the study is to determine the effect of the use of non-nutritive sucking vs non-nutritive sucking combined with breast milk on neonatal comfort during diaper change in preterm infants.

Detailed description

Newborns are faced with many painful interventions including tactile stimulation such as diaper change, axillary temperature measurement, intraoral and endotracheal aspiration during the postnatal period in the Neonatal Intensive Care Units (NICU) at the beginning of their lives. Painful interventions negatively affect the physiological parameters, comfort, sleep, growth and hospital stay of newborns. As a result of these interventions, the stress level increases in preterm infants. Increased stress level can cause long-term sequelae, risk of intraventricular hemorrhage, increased oxygen consumption and hypertension. In addition, the increased stress experience may make the infant sensitive to pain and stress in other periods of his life. This randomized controlled prospective study was planned to be conducted in the NICU of a private hospital with branches in Istanbul until the whole sample group would be reached. In the NICU, where the study will be conducted, preterm infants will be divided into two groups as control and experimental groups. Non-nutritive sucking (NNS) combined with breast milk will be used during diaper change for newborns in the experimental group, and only NNS will be used in the control group. NNS will be given to both groups 5 minutes before diaper change. The comfort level of the newborns will be measured with the Premature Infant Comfort Scale before the NNS, 5 minutes after the NNS, during the procedure, immediately after the procedure and 5 minutes after the procedure.

Conditions

• Infant, Premature

Interventions

Type	Name	Description
PROCEDURE	Only NNS	Before the procedure, the Premature Infant Comfort Scale shall be filled out. Procedure steps for the control group: * Materials shall be prepared (napkins, non-sterile gloves, pacifier) * Hands shall be washed; gloves shall be worn. * The infant shall be given a NNS just before the procedure and continue until the 5th minute after the procedure. * The diapers shall be changed. * Hands shall be washed after the procedure. * The Premature Infant Comfort Scale shall be assessed during, shortly after, and 5 minutes after the procedure.
PROCEDURE	NNS Combined with Breast Milk	* Before the procedure, the Premature Infant Comfort Scale shall be filled out. * Materials shall be prepared (napkins, non-sterile gloves, pacifier, breast milk, cup) * Hands shall be washed; gloves shall be worn. * The cylindrical part of a pacifier shall be in touch with breast milk for 5 seconds. The infant shall be given the pacifier, combined with breast milk, just before the procedure and continue until the 5th minute after the procedure. * The diapers shall be changed. * Hands shall be washed after the procedure. * The Premature Infant Comfort Scale shall be assessed during, shortly after, and 5 minutes after the procedure.

Timeline

• Start date: 2021-11-01
• Primary completion: 2022-06-23
• Completion: 2022-06-23
• First posted: 2021-10-28
• Last updated: 2023-01-10

Locations

1 site across 1 country: Turkey (Türkiye)