Status:
COMPLETED
Non-pharmacological Interventions for Procedural Pain in Premature Neonates
Lead Sponsor:
Loma Linda University
Conditions:
Prevention of Procedural Pain
Reduction of Procedural Pain
Eligibility:
All Genders
Up to 1 years
Phase:
NA
Brief Summary
A. Specific Aims Premature infants admitted to the neonatal intensive care unit (NICU) require up to several hundred procedures during their hospitalization. Many of these are tissue-damaging procedur...
Eligibility Criteria
Inclusion
- Potential subjects are premature infants between 28-36 weeks gestation, have an arterial or central catheter in place and have a clinically required heel lance.
Exclusion
- Requirement for surgery
- Intraventricular hemorrhage (IVH) ≥ grade 3
- Neonates on medications such as morphine, fentanyl, versed, muscle relaxants, phenobarbital, or dilantin
- Renal injury (plasma creatinine \> 1 mg/dl)
- Severe cyanotic heart disease or severe respiratory distress
- Chromosomal anomaly
- Facial anomaly
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2019
Estimated Enrollment :
203 Patients enrolled
Trial Details
Trial ID
NCT02214589
Start Date
August 1 2014
End Date
December 1 2019
Last Update
March 13 2020
Active Locations (1)
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1
Loma Linda University Children's Hospital
Loma Linda, California, United States, 92354