drugset / Trial / NCT04967118

Neonatal Pain Management and Pain Monitoring Using New Methods

NCT04967118

Unknown 36 enrolled University of Oulu
RandomizedCrossoverSingle-blindTreatment

Summary

The aim of this randomized controlled study with crossover design is to examine the effectiveness of mother-driven interventions, skin-to-skin contact (SSC) and recorded mother's heartbeats as sound and vibration (MHB), compared to oral glucose in relieving neonatal acute pain related to heel lance as a painful procedure. The effectiveness of interventions will be assessed using validated pain scales (PIPP-R and NIAPAS), changes in sensory cortex activation (near-infrared spectroscopy, NIRS) and changes in physiological indicators (oxygen saturation, heart rate, respiratory rate). The secondary objectives will include evaluating the effectiveness of interventions in relation to infant recovery and evaluating the use of NIRS monitoring in relation to neonatal pain assessment scales.

Timeline

Start
2023-05-02
Primary completion
2024-05-31
Completion
2024-12-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Glucose Unknown 30 % Oral

Indications

No indication recorded.