PainPhase 3NCT00571636
Continuous Infusion of Fentanyl in Preterm on MV
A Phase 3 study testing Fentanyl and 5% glucose solution in people with Pain and Infant, Premature, Diseases, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 32 weeks
- Conditions the study is for
- Pain, Infant, Premature, Diseases, Respiration; Insufficient or Poor, Newborn
- What is being tested?
- Fentanyl and 5% glucose solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2007to Jul 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 32 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Continuous Infusion of Fentanyl for Pain Control in Preterm Newborn on Mechanical Ventilation
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.
Read the 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.
- Being tested
- Fentanyl, 5% glucose solution
- Keywords
- Opioids infusion, mechanical ventilation
- Medical subject headings
- Pain, Infant, Premature, Diseases, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FentanylDrug
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 solutionDrug
ev continuous infusion
| Study group | Role | What they receive |
|---|---|---|
| fentanyl | Active comparator | Patients assigned to this arm will receive continuous infusion of fentanyl + open label boluses of Fentanyl if necessary. Receives: Drug: Fentanyl |
| placebo | Placebo comparator | Patients assigned to this arm will receive continuous infusion of placebo+ open label boluses of Fentanyl if necessary. Receives: Drug: 5% glucose solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days
Secondary outcomes (1)
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
Measured: until discharge from hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2007 (estimated)
- Study startDec 2007
- Primary completionApr 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Agenzia Italiana del Farmaco
- Responsible party
- Principal investigator, Ancora Gina, IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Investigators
- Gina Ancora, Doctor, Principal investigator, St'Orsola-Malpighi General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00571636
- Sponsor's protocol ID
- NEO 01/2005
- Other IDs
- FARM63TMS3
- Status last verified
- Oct 2011
- First submitted
- 11 Dec 2007
- Last updated
- 12 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23582138
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Continuous Infusion of Fentanyl for Pain Control in Preterm Newborn on Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT00571636
- Acronym / sponsor ID
- NEO 01/2005
- Keywords
- Opioids infusion, mechanical ventilation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Collaborators
- Agenzia Italiana del Farmaco
- Study start
- Dec 2007
- Primary completion
- Apr 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 12 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fentanyl | Active comparator | Drug: FentanylPatients assigned to this arm will receive continuous infusion of fentanyl + open label boluses of Fentanyl if necessary. |
| placebo | Placebo comparator | Drug: 5% glucose solutionPatients assigned to this arm will receive continuous infusion of placebo+ open label boluses of Fentanyl if necessary. |
Who may qualify
- Ages
- Up to 32 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FentanylThe 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. | Drug | fentanyl |
| 5% glucose solutionev continuous infusion | Drug | placebo |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2011.
- Derived from this study: PubMed 23582138Ancora 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.
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gina Ancora, Doctor principal investigator
St'Orsola-Malpighi General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fentanyl and 5% glucose solution in people with Pain and Infant, Premature, Diseases, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00571636, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2011.