What side effects are associated with this type of intervention?

Treatments for Neonatal Respiratory Distress Syndrome (RDS) using IV fentanyl and atropine can have several side effects. Fentanyl, an opioid analgesic, provides pain relief and sedation but may cause respiratory depression, increased need for ventilatory support, and potential dependency. Atropine, an anticholinergic, reduces vagal tone and prevents bradycardia but can lead to dry mouth, urinary retention, and tachycardia. Combining these medications aims to reduce stress and improve procedural outcomes, but careful monitoring is essential to manage these potential side effects.

What prior FDA approvals exist?

The FDA has approved various treatments for Neonatal Respiratory Distress Syndrome (RDS), including surfactant therapy and mechanical ventilation. While specific FDA approvals for the combination of IV fentanyl and atropine in the context of RDS are not detailed, these drugs are used in clinical practice for their respective roles in pain relief, sedation, and prevention of bradycardia during procedures like Less Invasive Surfactant Administration (LISA). Fentanyl provides effective analgesia and sedation, while atropine helps manage heart rate and reduce vagal responses. These medications are part of broader supportive care strategies in managing preterm infants with RDS.

What other types of research exist?

Promising alternatives to IV fentanyl and atropine for Neonatal Respiratory Distress Syndrome patients include propofol and remifentanil. Propofol offers faster intubation times, while remifentanil provides effective sedation and analgesia with rapid dose adjustments.

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Premedication for Neonatal Respiratory Distress Syndrome (PRELISA Trial)

Phase 4

Recruiting

Led By Sharmistha Saha, MD

Research Sponsored by University of Texas Southwestern Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Infants ≥29 weeks gestational age between 0-72 hours of life on CPAP for respiratory support who qualify for the LISA procedure as determined by the primary team using Parkland OPTISURF guidelines

Be younger than 18 years old

Must not have

Infants with known severe congenital anomalies (including complex congenital heart disease, airway, and central nervous system anomalies)

Infants requiring intubation prior to surfactant therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at time of lisa procedure

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial tests if giving preterm infants fentanyl and atropine before a lung treatment can reduce the risk of low heart rate and low oxygen levels. The study focuses on infants born prematurely who have breathing problems. Fentanyl has been studied for its potential to reduce stress and improve outcomes in these infants.

Who is the study for?

The PRELISA trial is for preterm infants aged between 0-72 hours, at least 29 weeks gestational age, needing CPAP respiratory support and qualifying for the LISA procedure. It excludes those with severe congenital anomalies, born to mothers with opioid addiction or on methadone treatment, or requiring intubation before surfactant therapy.

What is being tested?

This study tests if IV fentanyl and atropine given before the LISA procedure can reduce bradycardia and hypoxemia events in preterm infants compared to a placebo. The trial is double-blinded and randomized; success rates of the first attempt and effects on cerebral oxygenation are also measured.

What are the potential side effects?

Potential side effects from IV fentanyl may include slowed breathing rate, low blood pressure, drowsiness or sedation. Atropine could cause dry mouth, blurred vision, sensitivity to light or an increased heart rate. Side effects will be closely monitored during the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My baby is on CPAP for breathing support and qualifies for the LISA procedure.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My infant has severe birth defects, including heart, airway, or brain issues.

Select...

My infant needed a breathing tube before receiving surfactant treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time of medication infusion to completion of lisa procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time of medication infusion to completion of lisa procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and time of medication infusion to completion of lisa procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Interventional procedure

Secondary study objectives

Intubation rate

Mean duration of bradycardia and hypoxemia events

Mean number of attempts required

+2 more

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: IV Atropine and Fentanyl Premedication ArmExperimental Treatment1 Intervention

Participants will receive premedication regimen of 20 micrograms/kilogram intravenous atropine and 0.5 micrograms/kilogram intravenous fentanyl prior to performance of LISA.

Group II: IV Normal Saline Placebo ArmPlacebo Group1 Intervention

Participants will receive two intravenous Normal Saline infusions in quantities equivalent to the calculated volumes of atropine and fentanyl for participant's weight prior to performance of LISA.

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Neonatal Respiratory Distress Syndrome (NRDS) include opioid analgesics like fentanyl and anticholinergics like atropine, as well as surfactant replacement therapy. Fentanyl provides pain relief and sedation, reducing the stress response in ventilated neonates. Atropine reduces vagal tone and prevents bradycardia during procedures. Surfactant replacement therapy reduces surface tension in the lungs, improving oxygenation and reducing disease severity. These treatments are crucial for stabilizing the neonate's condition, enhancing respiratory function, and minimizing complications such as intracranial hemorrhage and bronchopulmonary dysplasia.

Effect of morphine and pancuronium on the stress response in ventilated preterm infants.Surfactant replacement therapy with a single postventilatory dose of a reconstituted bovine surfactant in preterm neonates with respiratory distress syndrome: final analysis of a multicenter, double-blind, randomized trial and comparison with similar trials. The Surfactant-TA Study Group.Respiratory disorders of the neonate.