The Effect of Breast Milk, 10% and 20% Dextrose on Pain and Physiological Variables During Heel Puncture in Infants | NCT07716813

NCT07716813

Overview

NCT ID: NCT07716813
Lead Sponsor: Mersin UniversityOTHER
Official Title: The Effect of Oral Breast Milk and 20% Dextrose Solution Administered With Supportive Positioning Methods on Pain and Physiological Variables During Heel Puncture Blood Sampling in Preterm Infants: A Randomized Controlled Trial
Brief 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.

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 24, 2026Actual
Start Date: Jul 18, 2026Estimated
Primary Completion Date: Aug 15, 2026Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Child (0-17)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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.

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 96Estimated
Primary Purpose: Supportive Care
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Single

Contacts and Locations

Central Contacts: No data available
Locations: Mersin University

Overview

Status and Timeline

Participation Criteria

Study Plan

Contacts and Locations

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