Continuous Infusion of Fentanyl in Preterm on MV

NCT00571636 | Completed Phase 3 DMC

• 2 other identifiers: NEO 01/2005FARM63TMS3
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Infant, Premature, Diseases; Respiration; Insufficient or Poor, Newborn

Keywords

Opioids infusion; mechanical ventilation

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  until discharge from hospital

Study Arms (2)

fentanyl

ACTIVE COMPARATOR

Patients assigned to this arm will receive continuous infusion of fentanyl + open label boluses of Fentanyl if necessary.

Drug: Fentanyl

placebo

PLACEBO COMPARATOR

Patients assigned to this arm will receive continuous infusion of placebo+ open label boluses of Fentanyl if necessary.

Drug: 5% glucose solution

Interventions

Fentanyl DRUG

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.

fentanyl

5% glucose solution DRUG

ev continuous infusion

placebo

Eligibility Criteria

• Age: Up to 32 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead
• Agenzia Italiana del Farmaco: collaborator

Study Sites (1)

St'Orsola-Malpighi General Hospital

Bologna, BO, 40138, Italy

Location

Related Publications (1)

• 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.

  PMID: 23582138 DERIVED

MeSH Terms

Conditions

Pain; Infant, Premature, Diseases; Respiratory Aspiration

Interventions

Fentanyl

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Gina Ancora, Doctor

  St'Orsola-Malpighi General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 11, 2007
• First Posted: December 12, 2007
• Study Start: December 1, 2007
• Primary Completion: April 1, 2010
• Study Completion: July 1, 2010
• Last Updated: October 12, 2011

Record last verified: 2011-10

Locations

IT (1)