New methods for managing pain in newborns
Neonatal Pain Management and Pain Monitoring Using New Methods: A Randomized Controlled Trial With Crossover Design
This study tests if skin-to-skin contact and a mother's heartbeat can help reduce pain in newborns during heel pricks better than giving them sugar water.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 32 Weeks to 42 Weeks |
| Sex | All |
| Sponsor | University of Oulu Academic / other |
| Locations | 1 site (Oulu) |
| Trial ID | NCT04967118 on ClinicalTrials.gov |
What this trial studies
This randomized controlled study examines the effectiveness of mother-driven interventions, such as skin-to-skin contact and recorded mother's heartbeats, compared to oral glucose in alleviating acute pain in neonates during heel lance procedures. The study employs a crossover design and assesses pain relief using validated pain scales, changes in sensory cortex activation through near-infrared spectroscopy, and physiological indicators like oxygen saturation and heart rate. Secondary objectives include evaluating infant recovery and the utility of NIRS monitoring in relation to pain assessment scales.
Who should consider this trial
Good fit: Ideal candidates for this study are neonates born between 32 and 42 weeks of gestational age who are admitted to the NICU and whose parents can communicate in Finnish.
Not a fit: Patients who are older than 14 days postnatal age, have low Apgar scores, significant cerebral hemorrhage, major congenital anomalies, are intubated, or have received analgesics or sedatives within the last 24 hours may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide effective non-pharmacological pain management strategies for neonates, improving their comfort during painful procedures.
How similar studies have performed: While the approach of using mother-driven interventions for pain management in neonates is gaining interest, this specific combination of methods has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Oulu
- Oulu University Hospita — Oulu, Finland (Recruiting)
Study contacts
- Study coordinator: Anna-Kaija Palomaa
- Email: annakaija.palomaa@gmail.com
- Phone: +358400892159
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.