Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
128 participants
INTERVENTIONAL
2007-12-31
2010-07-31
Brief Summary
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* Group A) continuous infusion of Fentanyl + open label boluses of Fentanyl;
* Group B) continuous infusion of placebo + open label boluses of Fentanyl.
Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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fentanyl
Patients assigned to this arm will receive continuous infusion of fentanyl + open label boluses of Fentanyl if necessary.
Fentanyl
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.
placebo
Patients assigned to this arm will receive continuous infusion of placebo+ open label boluses of Fentanyl if necessary.
5% glucose solution
ev continuous infusion
Interventions
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Fentanyl
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.
5% glucose solution
ev continuous infusion
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
32 Weeks
ALL
No
Sponsors
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Agenzia Italiana del Farmaco
OTHER_GOV
IRCCS Azienda Ospedaliero-Universitaria di Bologna
OTHER
Responsible Party
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Ancora Gina
MD
Principal Investigators
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Gina Ancora, Doctor
Role: PRINCIPAL_INVESTIGATOR
St'Orsola-Malpighi General Hospital
Locations
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St'Orsola-Malpighi General Hospital
Bologna, BO, Italy
Countries
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References
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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.
Other Identifiers
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FARM63TMS3
Identifier Type: -
Identifier Source: secondary_id
NEO 01/2005
Identifier Type: -
Identifier Source: org_study_id