Clinical trial NCT04967118: Neonatal Pain Management and Pain Monitoring Using New Methods
Official title: Neonatal Pain Management and Pain Monitoring Using New Methods: A Randomized Controlled Trial With Crossover Design
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain, Acute
Procedural Pain
Infant
Lead sponsor: University of Oulu
Sponsor class: OTHER
First posted: 2021-07-19
Enrollment: 36
Sex: ALL
Minimum age (years): 32
Maximum age (years): 42
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: A crossover design with each child as his or her own control will be used to minimize interchild variability. Order of interventions will be randomly assigned by computer-generated program.
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Gestational Age (GA) at birth 32+0 - 42+0
* Admitted to NICU
* Parents are able to read, write and speak Finnish

Exclusion Criteria:

* With a postnatal age of 14 days or more
* Apgar points were 6 or less at 5 minutes of age
* Has been found grade III or IV cerebral haemorrhage
* Major congenital anomalies
* Has intubated or receiving a nCPAP
* Has received analgesics or sedatives for less than 24 hours prior to the study

Primary outcomes:
measure: Change in scores of Premature Infant Pain profile-Revised (PIPP-R) scale
timeFrame: Baseline 1, measured pre-intervention
measure: Change in scores of Premature Infant Pain profile-Revised (PIPP-R) scale
timeFrame: Baseline 2, measured pre-procedure
measure: Change in scores of Premature Infant Pain profile-Revised (PIPP-R) scale
timeFrame: Measured during painful procedure
measure: Change in scores of Premature Infant Pain profile-Revised (PIPP-R) scale
timeFrame: Measured immediately after painful procedure
measure: Change in scores of Neonatal Infant Acute Pain Assessment Scale (NIAPAS)
timeFrame: Baseline 1, measured pre-intervention
measure: Change in scores of Neonatal Infant Acute Pain Assessment Scale (NIAPAS)
timeFrame: Baseline 2, measured pre-procedure
measure: Change in scores of Neonatal Infant Acute Pain Assessment Scale (NIAPAS)
timeFrame: Measured during painful procedure
measure: Change in scores of Neonatal Infant Acute Pain Assessment Scale (NIAPAS)
timeFrame: Measured immediately after painful procedure
measure: Change in the activation in the somatosensory cortical areas following the noxious stimulation (baseline)
timeFrame: Baseline 1, measured pre-intervention
measure: Change in the activation in the somatosensory cortical areas following the noxious stimulation
timeFrame: Baseline 2, measured pre-procedure
measure: Change of the activation in the somatosensory cortical areas following the noxious stimulation
timeFrame: Measured during painful procedure
measure: Change of the activation in the somatosensory cortical areas following the noxious stimulation
timeFrame: Measured immediately after painful procedure
measure: Change in heart rate (HR)
timeFrame: Baseline 1, measured pre-intervention
measure: Change in heart rate (HR)
timeFrame: Baseline 2, measured pre-procedure
measure: Change in heart rate (HR)
timeFrame: Measured during painful procedure
measure: Change in heart rate (HR)
timeFrame: Measured immediately after procedure
measure: Change in oxygen saturation
timeFrame: Baseline 1, measured pre-intervention
measure: Change in oxygen saturation
timeFrame: Baseline 2, measured pre-procedure
measure: Change in oxygen saturation
timeFrame: Measured during painful procedure
measure: Change in oxygen saturation
timeFrame: Measured immediately after painful procedure
measure: Change in respiratory rate
timeFrame: Baseline 1, measured pre-intervention
measure: Change in respiratory rate
timeFrame: Baseline 2, measured pre-procedure
measure: Change in respiratory rate
timeFrame: Measured during procedure
measure: Change in respiratory rate
timeFrame: Measured immediately after procedure
Secondary outcomes:
measure: Recovery measured by change in scores of the Premature Infant Pain profile-Revised (PIPP-R)
timeFrame: 3 minutes after painful procedure
measure: Recovery measured by change in scores of the Premature Infant Pain profile-Revised (PIPP-R)
timeFrame: 5 minutes after painful procedure
measure: Recovery measured by change in scores of the Premature Infant Pain profile-Revised (PIPP-R)
timeFrame: 10 minutes after painful procedure
measure: Recovery measured by change in scores of the Neonatal Infant Acute Pain Assessment Scale (NIAPAS)
timeFrame: 3 minutes after painful procedure
measure: Recovery measured by change in scores of the Neonatal Infant Acute Pain Assessment Scale (NIAPAS)
timeFrame: 5 minutes after painful procedure
measure: Recovery measured by change in scores of the Neonatal Infant Acute Pain Assessment Scale (NIAPAS)
timeFrame: 10 minutes after painful procedure
measure: Recovery as measured by changes in somatosensory cortex activation
timeFrame: 3 minutes after painful procedure
measure: Recovery as measured by changes in somatosensory cortex activation
timeFrame: 5 minutes after painful procedure
measure: Recovery as measured by changes in somatosensory cortex activation
timeFrame: 10 minutes after painful procedure
measure: Recovery as measured by changes in heart rate (HR)
timeFrame: 3 minutes after painful procedure
measure: Recovery as measured by changes in heart rate (HR)
timeFrame: 5 minutes after painful procedure
measure: Recovery as measured by changes in heart rate (HR)
timeFrame: 10 minutes after painful procedure
measure: Recovery as measured by changes in oxygen saturation
timeFrame: 3 minutes after painful procedure
measure: Recovery as measured by changes in oxygen saturation
timeFrame: 5 minutes after painful procedure
measure: Recovery as measured by changes in oxygen saturation
timeFrame: 10 minutes after painful procedure
measure: Recovery as measured by changes in respiratory rate
timeFrame: 3 minutes after painful procedure
measure: Recovery as measured by changes in respiratory rate
timeFrame: 5 minutes after painful procedure
measure: Recovery as measured by changes in respiratory rate
timeFrame: 10 minutes after painful procedure
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: Oulu University Hospita
Study officials:
References: