Clinical trial

Neonatal Pain Management and Pain Monitoring Using New Methods: A Randomized Controlled Trial With Crossover Design

Name

296/2018

Description

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.

Trial arms

Trial start

2023-05-02

Estimated PCD

2024-05-31

Trial end

2024-12-31

Status

Recruiting

Treatment

Skin-to-skin contact

Diaper clad baby will be placed ventral position on bare chest of mother 30 minute prior to the heel lance

Arms:

Skin-to-skin contact

Other names:

Kangaroo Mother Care

Mother's heartbeats as sound and vibration

The mother's heartbeat will be recorded and the heartbeat sounds will be saved to the platform. The platform will be placed under the infant's mattress and the heartbeat will be started 30 minute prior to the heel lance.

Arms:

Mother's heartbeats as sound and vibration

30% oral glucose

The infant will be given 30% oral glucose solution 2 minutes before the injection

Arms:

30% oral glucose

Other names:

Sweet taste

Size

Primary endpoint

Change in scores of Premature Infant Pain profile-Revised (PIPP-R) scale

Baseline 1, measured pre-intervention

Change in scores of Premature Infant Pain profile-Revised (PIPP-R) scale

Baseline 2, measured pre-procedure

Change in scores of Premature Infant Pain profile-Revised (PIPP-R) scale

Measured during painful procedure

Change in scores of Premature Infant Pain profile-Revised (PIPP-R) scale

Measured immediately after painful procedure

Change in scores of Neonatal Infant Acute Pain Assessment Scale (NIAPAS)

Baseline 1, measured pre-intervention

Change in scores of Neonatal Infant Acute Pain Assessment Scale (NIAPAS)

Baseline 2, measured pre-procedure

Change in scores of Neonatal Infant Acute Pain Assessment Scale (NIAPAS)

Measured during painful procedure

Change in scores of Neonatal Infant Acute Pain Assessment Scale (NIAPAS)

Measured immediately after painful procedure

Change in the activation in the somatosensory cortical areas following the noxious stimulation (baseline)

Baseline 1, measured pre-intervention

Change in the activation in the somatosensory cortical areas following the noxious stimulation

Baseline 2, measured pre-procedure

Change of the activation in the somatosensory cortical areas following the noxious stimulation

Measured during painful procedure

Change of the activation in the somatosensory cortical areas following the noxious stimulation

Measured immediately after painful procedure

Change in heart rate (HR)

Baseline 1, measured pre-intervention

Change in heart rate (HR)

Baseline 2, measured pre-procedure

Change in heart rate (HR)

Measured during painful procedure

Change in heart rate (HR)

Measured immediately after procedure

Change in oxygen saturation

Baseline 1, measured pre-intervention

Change in oxygen saturation

Baseline 2, measured pre-procedure

Change in oxygen saturation

Measured during painful procedure

Change in oxygen saturation

Measured immediately after painful procedure

Change in respiratory rate

Baseline 1, measured pre-intervention

Change in respiratory rate

Baseline 2, measured pre-procedure

Change in respiratory rate

Measured during procedure

Change in respiratory rate

Measured immediately after procedure

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': '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.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': "Two research assistants (NICU nurses) who are blinded to the intervention condition (30% oral glucose and combination of 30% oral glucose and the mother's heartbeat intervention) will be perform calculation of infant PIPP-R and NIAPAS scores independently. Calculating NIAPAS scores will requires observation of the neonate's body, so during the skin-to-skin contact the intervention condition cannot be blinded. NIRS signals will be analyzed by researchers who are unaware of the nature of intervention and whether they are analyzing a noxious or non-noxious stimulation. To minimize observer bias, research assistants and researchers analyzing the NIRS signal will not be permitted to attend data collection sessions and will not share datasets or communicate with each other regarding the study.", 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 36, 'type': 'ESTIMATED'}}

Updated at

2023-11-30

1 organization

Organization

University of Oulu