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

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 months later Aug 15, 2026 → Oct 25, 2026
See other at-risk trials from Mersin University

Record History

See every version on ClinicalTrials.gov ↗

  1. Minor Primary completion pushed from Aug 15, 2026 to Oct 25, 2026 Show 4 more changesShow less
    • Study completion pushed from Sep 30, 2026 to Dec 30, 2026
    • Eligibility criteria expanded, about 32 words
    • Study description expanded, about 10 words
    • Publications: details revised at 9 of 9 entries
  2. Notable Recruitment opened
    • Site details revised
    v3
  3. Minor Eligibility criteria revised
    • Study title revised
    • Study description shortened, about 4 words
    v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07716813
Lead Sponsor Mersin University
Conditions
(from sponsor)
Newborn Care, Pain Management, Physiological Parameters During Newborn Care İn Newborn's, Breast Milk, Premature
Related terms Agnosia, Pain, Premature Birth
Enrollment 96 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov