The Effect of Breast Milk, 10% and 20% Dextrose on Pain and Physiological Variables During Heel Puncture in Infants

NCT07716813 · tracked via the Priya Life Science Turkey tracker

Sponsor

Mersin University

Phase

Not applicable

Started

2026-07-18

Last updated

2026-10-08

Condition(s) studied

Newborn CarePain ManagementPhysiological Parameters During Newborn Care İn Newborn'sBreast MilkPremature

Investigational drug(s) / intervention(s)

Administering oral breast milk in a supportive positionAdministering oral 10% dextrose in a supportive positionAdministering oral 20% dextrose in a supportive position

Administering oral breast milk in a supportive position: Administering oral breast milk in a supportive position

Administering oral 10% dextrose in a supportive position: Application of 10% dextrose solution with supportive positioning during routine heel prick blood sampling.

Administering oral 20% dextrose in a supportive position: Application of 20% dextrose solution with supportive positioning during routine heel prick blood sampling.

Study summary

Pain, defined by the International Association for the Study of Pain as a subjective, sensory, and emotional experience, differs from nociception, which is merely a neural activity. Premature newborns, whose inhibitory fibers are not yet mature due to anatomical and physiological development and who have insufficient endogenous opioid release, experience painful stimuli much more intensely. The inability of this age group to verbally express pain makes the diagnosis, assessment, and management of pain entirely dependent on healthcare professionals. Pain that is not effectively managed leads to stress and loss of comfort in the short term, while in the long term it can cause permanent neurodevelopmental problems and alter the individual's pain threshold later in life.

Premature infants, especially those in Neonatal Intensive Care Units (NICUs), are exposed to invasive procedures that cause moderate to severe pain, such as heel prick tests, much more frequently than healthy term infants. In this context, pain management is a fundamental and essential nursing responsibility for the infant's neuroprotective developmental care. The literature shows that various non-pharmacological methods, such as oral sucrose, non-nutritive sucking (NNS), facilitated flexion, and wrapping, are used to alleviate pain during interventional procedures. Although more readily available in NICUs, studies on the effectiveness of oral glucose solutions are more limited compared to sucrose.

This research, designed to address this gap in the existing literature, aims to investigate the effect of "oral breast milk, 20%, and 10% dextrose solution administered with supportive positioning methods" on pain reduction during heel prick blood sampling in premature newborns. The results of this research are expected to contribute to the development of a new, easily applicable, effective, and evidence-based nursing intervention strategy for NICUs.

Eligibility

Sex

ALL

Min age

32 Weeks

Max age

37 Months

Healthy volunteers

Inclusion Criteria: * Parental consent for the baby's participation in the study * Admission to Mersin University Hospital NICU between July 16, 2026 and December 30, 2026, * Gestational age at birth between 33 weeks and 37 weeks, * Postnatal age less than 7 days, * Heel prick blood test planned within the scope of NTP, * Stable clinical condition, * Absence of genetic or metabolic problems, * Developed sucking-swallowing and breathing coordination, * Having been fed at least 30 minutes before the procedure, * No experience with invasive procedures in the last 6 hours before the procedure, * No administration of non-opioid analgesics in the last 4 hours before the procedure, * No administration of opioid analgesics and sedative agents in the last 24 hours before the procedure, * Spontaneous respiration at 21% FiO2, * Absence of neurological problems (e.g., asphyxia, hypoxic ischemic encephalopathy, intraventricular hemorrhage, periventricular leukomalacia, spinal cord injury…), * Absence of contraindications to oral glucose/breast milk administration (e.g., necrotizing enterocolitis or suspicion thereof, feeding intolerance, tracheoesophageal fistula, absence of esophageal atresia…), * Absence of endocrine problems (e.g., hypoglycemia, hyperglycemia, large for gestational age, absence of a diabetic mother…), Exclusion Criteria: * Parental disapproval of infant's participation in the study * No hospitalization at Mersin University Hospital NICUs between July 16, 2026 and December 30, 2026, * Gestational age at birth less than 33 weeks or greater than 37 weeks, * Postnatal age greater than 7 days, * Heel prick blood test not planned within the scope of NTP, * Clinical condition not stable, * Lack of developed sucking-swallowing and breathing coordination, * Having been fed within 30 minutes of the procedure, * Having had invasive procedures experience in the last 6 hours before the procedure, * Having received non-opioid analgesics in the last 4 hours before the procedure, * Having received opioid analgesics and sedative agents in the last 24 hours before the procedure, * Genetic or metabolic problem The following are contraindications: * Being on invasive or non-invasive mechanical ventilation support, * Having a neurological problem, * Oral glucose/breast milk administration being contraindicated, * Having an endocrine and metabolic problem.

Primary outcome measure(s)

Change in the mean score of neonatal pain, agitation and sedation scale — During the procedure
The Neonatal Pain, Agitation, and Sedation Scale has a maximum score of 10, a minimum score of 0, and no lower limit. It is generally interpreted that "the higher the score on the scale, the more pain the baby is in."

Trial sites (1)

Facility	City	Region	Status
Mersin University	Mersin	Turkey (Türkiye)	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07716813 on ClinicalTrials.gov ↗ ← All trials in Turkey