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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-01

Study Completion Date

2022-06-23

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparison of the Effects of Oral Stimulation and Non-nutritive Sucking Practices

NCT05249179

Premature Nutrition Disorders Sucking Behavior

UNKNOWN NA

Pain and Comfort During Endotracheal Suction in Premature Neonates

NCT05095285

Premature

COMPLETED NA

The Effect of Routine and Random Pacifier Use Methods in Preterm Infants

NCT05036915

Feeding Neonatal

COMPLETED NA

The Effect Of Oral Motor Stimulation And Nonnutritive Sucking To The Time Of Transition To Oral Nutrition In Preterm

NCT05310851

Preterm Nutrition Disorder, Infant Feeding; Difficult, Newborn

COMPLETED NA

The Effect of Non-nutritive Sucking on Pain During Examination for Retinopathy of Prematurity

NCT04463927

Pain

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Infant, Premature

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control group (Only NNS)

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.

Group Type EXPERIMENTAL

Only NNS

Intervention Type 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.

Experimental Group (NNS Combined with Breast Milk)

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.

Group Type EXPERIMENTAL

NNS Combined with Breast Milk

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

1 Day

Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No