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Not Yet Recruiting NCT07828795

Crochet Octopus in Reducing Procedural Pain During Heel Lance in Preterm Neonates

Conditions: Preterm Neonates, Heel Lance Procedures, Procedural Pain

Sex: All
Ages: 2 Days – 30 Days
Healthy volunteers: No
Phase: NA
Enrollment: 98
Sponsor: Mansoura University

Summary

Neonates, particularly those hospitalized in neonatal intensive care units (NICUs), are subjected to numerous painful procedures essential for their diagnosis and monitoring. Heel lance, performed for routine blood sampling, stands as one of the most frequently encountered painful experiences for these vulnerable infants, as robust neurobiological evidence confirms that even preterm infants possess the anatomical and functional capacity to perceive pain, manifesting measurable physiological, hormonal, and behavioral responses. The daily average of acute painful events can reach up to 10-15 procedures in the NICU, and repeated exposure to inadequately managed procedural pain has been associated with immediate physiological instability as well as longer-term alterations in stress regulation, somatosensory processing, and neurodevelopmental outcomes. These vulnerabilities are further compounded in preterm and low birth weight infants who require prolonged hospitalization and specialized care.

Eligibility Criteria

Inclusion Criteria * Preterm neonates: Gestational age 32-37 weeks * Age: 2-30 days postnatal * Clinically stable * Requiring heel lance for routine blood sampling Exclusion Criteria * Major congenital anomalies * Neurological disorders * Received pharmacological analgesia within 24 hours prior to the procedure * Receiving mechanical ventilation or continuous positive airway pressure (CPAP)

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07828795). StuddyBuddy aggregates publicly available trial information.