Continuous Infusion of Fentanyl in Preterm on MV
Primary Purpose
Pain, Infant, Premature, Diseases, Respiration; Insufficient or Poor, Newborn
Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Fentanyl
5% glucose solution
Sponsored by
About this trial
This is an interventional treatment trial for Pain focused on measuring Opioids infusion, mechanical ventilation
Eligibility Criteria
Inclusion Criteria:
- inborn neonates
- preterm neonates ≤ 32+ 6 days weeks gestation
- < 72 hours of life
- newborns on MV
- within 24 hours from the beginning of MV administered through an endotracheal tube
- parental written informed consent for participation in the study must be obtained
Exclusion Criteria:
- Evidence of severe birth asphyxia, that is an APGAR score below 4 at 5 minutes of age and/or umbilical arterial pH < 7.0
- Known genetic or chromosomal disorders
- Severe IVH (> grade II according to Volpe classification (30))
- Need for post-operative analgesic therapy in the first week of life
- Participation in another clinical trial of any placebo, drug, biological, or device conducted under the provisions of a protocol
Sites / Locations
- St'Orsola-Malpighi General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
fentanyl
placebo
Arm Description
Patients assigned to this arm will receive continuous infusion of fentanyl + open label boluses of Fentanyl if necessary.
Patients assigned to this arm will receive continuous infusion of placebo+ open label boluses of Fentanyl if necessary.
Outcomes
Primary Outcome Measures
The primary efficacy variable for this study will be the pain scores obtained during the study period. Procedural pain will be measured once a day by the PIPP scale. Chronic pain will be evaluated through the application of the EDIN scale 3 times a day.
Secondary Outcome Measures
Rate of MVd newborns at one week of age;Age at which neonates will reach total enteral feeding;Age of first meconium passage;Incidence of IVH, PVL or death within 28 days of life;Incidence of bladder globe and hypotension during the first week of life
Full Information
NCT ID
NCT00571636
First Posted
December 11, 2007
Last Updated
October 8, 2011
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Collaborators
Agenzia Italiana del Farmaco
1. Study Identification
Unique Protocol Identification Number
NCT00571636
Brief Title
Continuous Infusion of Fentanyl in Preterm on MV
Official Title
Efficacy and Safety of Continuous Infusion of Fentanyl for Pain Control in Preterm Newborn on Mechanical Ventilation
Study Type
Interventional
2. Study Status
Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Collaborators
Agenzia Italiana del Farmaco
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The objective of this randomized, double-blind trial is to compare the efficacy and safety of 2 therapeutic regimens of fentanyl administration in a population of preterm newborns of GA <= 32 weeks in MV:
Group A) continuous infusion of Fentanyl + open label boluses of Fentanyl;
Group B) continuous infusion of placebo + open label boluses of Fentanyl.
Detailed Description
The primary objective of the study is to evaluate the analgesic superiority of Fentanyl given as 'continuous infusion + boluses' versus 'boluses alone' by comparing pain scores obtained by the application of validated algometric scales for chronic pain (EDIN - Echelle Douleur Inconfort Nouveau-Nè) and acute pain (PIPP- Premature Infant Pain Profile).
The secondary objective of the study is to evaluate the safety equivalence of the above 2 therapeutic regimens by recording:
Rate of mechanically ventilated newborns at one week of age
Age at which neonates will reach total enteral feeding
Age (hours) of first meconium passage
Incidence of intraventricular haemorrhage (IVH), periventricular leucomalacia (PVL) or death within 28 days of life
Incidence of bladder globe during the first week of life
Incidence of hypotension during the first week of life
5.2.1 Pain measurement: during the study phase acute pain will be measured once a day during a heel prick by a validated algometric scale for acute pain (PIPP); chronic pain will be measured 3 times a day by a validated algometric scale for chronic pain (EDIN). Inter-rater reliability has been shown acceptable for both scales (26,27). Moreover, in October 2006 the Coordinating Center organized a theoretical and practical course on the correct application of the PIPP and EDIN scales (26,27) for all the participating centers in order to reduce the inter-Center variability in pain measurement.
The EDIN scores will be recorded in a specific CRF (CRF N°1, p. 15). The PIPP scores will be reported in a specific CRF (CRF N° 1, pp. 8-14).
5.2.2 Painful procedures: the following painful procedures, as well as the action taken to reduce pain, will be recorded in the same CRF (CRF N° 1, pp. 8-14):
heel pricks
endotracheal aspirations
venous blood samplings
pneumothorax drainage
peripherally inserted central catheter positioning
others (specify) 5.2.3 Fentanyl open label boluses administration: all the boluses of open label fentanyl administered according to the criteria reported in paragraph 6.1.1 have to be recorded in a special CRF (CRF N° 1, p. 7).
5.2.4 Instrumental examinations: a heart ultrasound has to be obtained in all newborns in the first week of life in order to diagnose patent ductus arteriosus. Brain ultrasound has to be repeated at 4, 7 days of age and then twice a month or when clinically indicated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Infant, Premature, Diseases, Respiration; Insufficient or Poor, Newborn
Keywords
Opioids infusion, mechanical ventilation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
128 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
fentanyl
Arm Type
Active Comparator
Arm Description
Patients assigned to this arm will receive continuous infusion of fentanyl + open label boluses of Fentanyl if necessary.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Patients assigned to this arm will receive continuous infusion of placebo+ open label boluses of Fentanyl if necessary.
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Intervention Description
The experimental drug will be diluted according to each NICU scheme and administered as an attach dose of 1 mcg/kg in 30' followed by continuous i.v. infusion of 1 mcg/kg/h. Infusion of the experimental drug has to begin within 24 hrs from the beginning of MV and has to be continued until the end of MV and not after 7 days of life. If the newborn is still on MV after the 7th day of life he/she will be treated for pain according to local protocols.
Open label boluses of Fentanyl during the study phase will be administered, in both groups when the EDIN pain score is > 6 and before performing the following invasive procedures:Peripherally inserted central venous catheter positioning;Re-intubation;Lumbar puncture;Pneumothorax or hydrothorax drainage.
Intervention Type
Drug
Intervention Name(s)
5% glucose solution
Intervention Description
ev continuous infusion
Primary Outcome Measure Information:
Title
The primary efficacy variable for this study will be the pain scores obtained during the study period. Procedural pain will be measured once a day by the PIPP scale. Chronic pain will be evaluated through the application of the EDIN scale 3 times a day.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Rate of MVd newborns at one week of age;Age at which neonates will reach total enteral feeding;Age of first meconium passage;Incidence of IVH, PVL or death within 28 days of life;Incidence of bladder globe and hypotension during the first week of life
Time Frame
until discharge from hospital
10. Eligibility
Sex
All
Maximum Age & Unit of Time
32 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
inborn neonates
preterm neonates ≤ 32+ 6 days weeks gestation
< 72 hours of life
newborns on MV
within 24 hours from the beginning of MV administered through an endotracheal tube
parental written informed consent for participation in the study must be obtained
Exclusion Criteria:
Evidence of severe birth asphyxia, that is an APGAR score below 4 at 5 minutes of age and/or umbilical arterial pH < 7.0
Known genetic or chromosomal disorders
Severe IVH (> grade II according to Volpe classification (30))
Need for post-operative analgesic therapy in the first week of life
Participation in another clinical trial of any placebo, drug, biological, or device conducted under the provisions of a protocol
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gina Ancora, Doctor
Organizational Affiliation
St'Orsola-Malpighi General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
St'Orsola-Malpighi General Hospital
City
Bologna
State/Province
BO
ZIP/Postal Code
40138
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
23582138
Citation
Ancora G, Lago P, Garetti E, Pirelli A, Merazzi D, Mastrocola M, Pierantoni L, Faldella G. Efficacy and safety of continuous infusion of fentanyl for pain control in preterm newborns on mechanical ventilation. J Pediatr. 2013 Sep;163(3):645-51.e1. doi: 10.1016/j.jpeds.2013.02.039. Epub 2013 Apr 10.
Results Reference
derived
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Continuous Infusion of Fentanyl in Preterm on MV
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