Clinical trial NCT05097495: Non-Nutritive Sucking vs Non-Nutritive Sucking Combined With Breast Milk on the Neonatal Comfort
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant, Premature
Keywords: Non Nutritive Sucking
Preterm Infant
Comfort
Lead sponsor: Acibadem University
Sponsor class: OTHER
First posted: 2021-10-28
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Comfort Level
timeFrame: 5 minutes before, immediately before, during, immediately after, and 5 minutes after the procedure.The change in these time intervals will be assessed.
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Şişli Kolan International Hastanesi
state: Şişli
Study officials:
affiliation: Acibadem University
name: Zehra Kan Öntürk, Assist Prof
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.
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.
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 Scholarsh. 2020 Sep;52(5):467-475. doi: 10.1111/jnu.12571. Epub 2020 Jun 20.