CompletedPhase 3

Continuous Infusion of Fentanyl in Preterm on MV

Italy128 participantsStarted 2007-12

Plain-language 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.

Who can participate

Age range

32 Weeks

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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.

Timeframe: 7 days

Trial details

NCT IDNCT00571636

SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2010-04

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