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Completed

NCT Number: NCT05097495

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

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.

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Key information

Age range

1 day–28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Şişli Kolan International Hastanesi

Istanbul, Şişli, 34360, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in Comfort Level

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

    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.

Sponsors and collaborators

Lead sponsor

Acibadem University

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 28, 2021
Registry last updated
Jan 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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