Safety and Efficacy of a Low Dose Naloxone Infusion in NICU Patients

Tracking Information
First Submitted Date	April 24, 2008
First Posted Date	April 29, 2008
Last Update Posted Date	July 21, 2011
Study Start Date	February 2008
Primary Completion Date	Not Provided
Current Primary Outcome Measures; (submitted: April 28, 2008)	The primary outcome variable will be a change in N-PASS scores. N-PASS scores will be compared before, during, and after administration of naloxone. [ Time Frame: Before, during, and after administration of naloxone ]
Original Primary Outcome Measures	Same as current
Change History	Complete list of historical versions of study NCT00669175 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures; (submitted: April 28, 2008)	The secondary outcome variable will be any changes in dosing of opioids within four hours of initiating or increasing naloxone infusion. Vital signs will be recorded per NICU protocol and closely monitored for changes. [ Time Frame: Collected and compared for the time period before, during, and for 5 days after naloxone infusion is administered ]
Original Secondary Outcome Measures	Same as current
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	Safety and Efficacy of a Low Dose Naloxone Infusion in NICU Patients
Official Title	Safety and Efficacy of a Low Dose Naloxone Infusion in NICU Patients
Brief Summary	When narcotic pain medicine, like fentanyl or morphine, is given to adults and children for several days, they often develop a tolerance to the medicine. This means they may need higher doses over time to get the same amount of pain control. When it is time to stop the medicine, the dose has to be decreased slowly so that the patient does not have withdrawal symptoms. Naloxone is a medicine that at high doses can reverse the effects of narcotics. At very small doses it may help prevent tolerance and lessen the severity of withdrawal symptoms. This could mean less narcotic pain medicine is needed over fewer days. The purpose of this research study is to see if giving naloxone to neonates who require narcotic infusions is safe and effective. Safety will be measured by the incidence of side effects. Efficacy will be measured by monitoring for changes in pain and sedation scores and need for more pain medicine.
Detailed Description	This is a prospective, non-randomized, single center, open label dose escalation study. We hypothesize that critically ill patients in the NICU may benefit from a low dose naloxone infusion resulting in decreased tolerance, less severe withdrawal symptoms, lower cumulative doses of opiates, and fewer total days of opiates, all while maintaining adequate or enhanced pain control and sedation. Establishing safety and efficacy data for this potentially beneficial therapy is an important first step towards using this therapy to decrease the risk of opioid tolerance and withdrawal in this population of infants.
Study Type	Observational
Study Design	Observational Model: Case-Only; Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Probability Sample
Study Population	Neonates admitted to the NICU within the first five days of life with an anticipated need for opiate infusion for at least four days
Condition	Opioid Tolerance; Pain
Intervention	Not Provided
Study Groups/Cohorts	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Completed
Estimated Enrollment; (submitted: April 28, 2008)	25
Original Estimated Enrollment	Same as current
Actual Study Completion Date	June 2011
Primary Completion Date	Not Provided
Eligibility Criteria	Inclusion Criteria: Neonates > 36 0/7 weeks estimated gestational age; Less than 30 days of life; Requiring admission to to the Neonatal Intensive Care Unit; Requiring continuous infusions of fentanyl or morphine analgesia; Anticipated to require opioid infusions for at least four days; Patients must be enrolled within 120 hours of initiating opioid infusions; All patients will also require mechanical ventilation prior to study entry. Exclusion Criteria: Preterm infants < 36 weeks gestation; Neonates with major neurologic anomalies, seizures; Opioid infusion administration for > 120 hours prior to study entry; Patients requiring ECMO support prior to study entry; Neonates born to mothers who are known to be opioid dependent
Sex/Gender	Sexes Eligible for Study: All
Ages	up to 30 Days (Child)
Accepts Healthy Volunteers	No
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	United States
Removed Location Countries
Administrative Information
NCT Number	NCT00669175
Other Study ID Numbers	08 01-003
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Eugenia Pallotto, Children's Mercy Hospital
Study Sponsor	Children's Mercy Hospital Kansas City
Collaborators	Not Provided
Investigators	Principal Investigator: Eugenia K Pallotto, MD Children's Mercy Hospital
PRS Account	Children's Mercy Hospital Kansas City
Verification Date	July 2011