Infant, Premature Clinical Trial
Official title:
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
Verified date | January 2023 |
Source | Acibadem University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | June 23, 2022 |
Est. primary completion date | June 23, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Day to 28 Days |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Turkey | Sisli Kolan International Hastanesi | Istanbul | Sisli |
Lead Sponsor | Collaborator |
---|---|
Acibadem University |
Turkey,
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 J — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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 Schol — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. |
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