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

NCT05097495 | Completed

• 1 other identifier: ATADEK-2021/15
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Infant, Premature

Keywords

Non Nutritive Sucking; Preterm Infant; Comfort

Outcome Measures

Primary Outcomes (1)

• Change in Comfort Level

  Infant's comfort level is evaluated with Premature Infant Comfort Scale.Premature Infant Comfort Scale (PICS), which is a multidimensional scale used in evaluating comfort and pain behaviorally and psychologically. The lowest score obtained from the scale is 35, and the highest score is 7. A high score on the scale indicates a low level of comfort.

  5 minutes before, immediately before, during, immediately after, and 5 minutes after the procedure.The change in these time intervals will be assessed.

Study Arms (2)

Control group (Only NNS)

EXPERIMENTAL

NNS will be started 5 minutes before diaper change. The use of NNS will continue during diaper change and up to 5 minutes after the application.

Procedure: Only NNS

Experimental Group (NNS Combined with Breast Milk)

EXPERIMENTAL

NNS combined with breast milk will be started 5 minutes before diaper change. The use of NNS combined with breast milk will continue during diaper change and up to 5 minutes after the application.

Procedure: NNS Combined with Breast Milk

Interventions

Only NNS PROCEDURE

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.

Control group (Only NNS)

NNS Combined with Breast Milk PROCEDURE

* 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.

Experimental Group (NNS Combined with Breast Milk)

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• The preterm infants whose parents agree to participate in the research and sign the informed consent form;
• Who have no congenital anomaly;
• Who have no chronic disease;
• Who have undergone no surgical procedure;
• Who have no neurological symptoms;
• Who have no NEC (necrotizing enterocolitis) diagnosis;
• Who are not sedated;
• Who are not hypoglycemic;
• Who have been administered no pharmacological analgesic method 4 hours before;
• Who are born between ≥28 and ≤36+6 gestation weeks, or are in between ≥28 and ≤36+6 gestation weeks during the procedure.

You may not qualify if:

• The infants whose parents do not agree to participate in the research and do not sign the informed consent form;
• Who have a congenital anomaly;
• Who have a chronic disease;
• Who had undergone a surgical procedure;
• Who have neurological symptoms;
• Who have NEC (necrotizing enterocolitis) diagnosis;
• Who are sedated;
• Who are hypoglycemic;
• Who have been administered no pharmacological analgesic method 4 hours prior;
• Who were between \<28 and \>36+6 gestation weeks.

Sponsors & Collaborators

• Acibadem University: lead

Study Sites (1)

Şişli Kolan International Hastanesi

Istanbul, Şişli, 34360, Turkey (Türkiye)

Location

Related Publications (5)

• Gibbins S, Stevens B. Mechanisms of sucrose and non-nutritive sucking in procedural pain management in infants. Pain Res Manag. 2001 Spring;6(1):21-8. doi: 10.1155/2001/376819.

  PMID: 11854758 BACKGROUND

• Lyngstad LT, Tandberg BS, Storm H, Ekeberg BL, Moen A. Does skin-to-skin contact reduce stress during diaper change in preterm infants? Early Hum Dev. 2014 Apr;90(4):169-72. doi: 10.1016/j.earlhumdev.2014.01.011. Epub 2014 Feb 16.

  PMID: 24548816 RESULT

• De Bernardo G, Riccitelli M, Sordino D, Giordano M, Piccolo S, Buonocore G, Perrone S. Oral 24% sucrose associated with nonnutritive sucking for pain control in healthy term newborns receiving venipuncture beyond the first week of life. J Pain Res. 2019 Jan 8;12:299-305. doi: 10.2147/JPR.S184504. eCollection 2019.

  PMID: 30662283 RESULT

• Naughton KA. The combined use of sucrose and nonnutritive sucking for procedural pain in both term and preterm neonates: an integrative review of the literature. Adv Neonatal Care. 2013 Feb;13(1):9-19; quiz 20-1. doi: 10.1097/ANC.0b013e31827ed9d3.

  PMID: 23360853 RESULT

• Wu HP, Yang L, Lan HY, Peng HF, Chang YC, Jeng MJ, Liaw JJ. Effects of Combined Use of Mother's Breast Milk, Heartbeat Sounds, and Non-Nutritive Sucking on Preterm Infants' Behavioral Stress During Venipuncture: A Randomized Controlled Trial. J Nurs Scholarsh. 2020 Sep;52(5):467-475. doi: 10.1111/jnu.12571. Epub 2020 Jun 20.

  PMID: 32564489 RESULT

MeSH Terms

Conditions

Premature Birth

Interventions

Milk, Human

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Milk; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Dairy Products; Food; Food and Beverages

Study Officials

• Zehra Kan Öntürk, Assist Prof

  Acibadem University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Prof.

Study Record Dates

• First Submitted: October 11, 2021
• First Posted: October 28, 2021
• Study Start: November 1, 2021
• Primary Completion: June 23, 2022
• Study Completion: June 23, 2022
• Last Updated: January 10, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)