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

Acibadem University

Status: Completed

Conditions: Infant, Premature

Treatments: Procedure: NNS Combined with Breast Milk; Procedure: Only NNS

Study type: Interventional

Funder types: Other

Identifiers

NCT05097495

ATADEK-2021/15

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 1 to 28 days old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Control group (Only NNS)

Experimental group

Description:

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.

Treatment:

Procedure: Only NNS

Experimental Group (NNS Combined with Breast Milk)

Experimental group

Description:

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.

Treatment:

Procedure: NNS Combined with Breast Milk