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Surfactant

Prophylactic Surfactant for Neonatal Respiratory Distress Syndrome (PreProMISe Trial)

Phase 4

Recruiting

Led By Matthew Derrick, MBBS

Research Sponsored by NorthShore University HealthSystem

Eligibility Criteria Checklist

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

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 36 weeks corrected gestational age

Awards & highlights

PreProMISe Trial Summary

This trial will test if giving premature babies surfactant at birth can improve their health outcomes compared to giving it only during a rescue treatment.

Who is the study for?

This trial is for premature infants born at 22-29 weeks' gestation. To participate, parents must give consent before birth. Infants with congenital anomalies or another cause of respiratory distress cannot join.Check my eligibility

What is being tested?

The study tests if giving a substance called Poractant Alfa right after birth improves health outcomes compared to waiting until the baby shows signs of breathing trouble (rescue treatment).See study design

What are the potential side effects?

Possible side effects of Poractant Alfa include blocked airways, changes in blood pressure, and oxygen levels fluctuating. These are monitored closely due to the vulnerability of preterm infants.

PreProMISe Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 36 weeks corrected gestational age

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~36 weeks corrected gestational age

This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 weeks corrected gestational age for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Endotracheal Intubation

Secondary outcome measures

Bronchopulmonary dysplasia

Side effects data

From 2016 Phase 3 trial • 88 Patients • NCT01709409

air leak

pulmonary hemorrhage

pulmonary interstitial emphysema

100%

80%

60%

40%

20%

Study treatment Arm

Curosurf (Group 1)

BLES (Group 2)

PreProMISe Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Prophylactic Surfactant via Minimally Invasive TechniqueExperimental Treatment1 Intervention

Infants randomized to prophylactic surfactant treatment will receive a dose of poractant alfa (Curosurf) administered under direct laryngoscopy using a surfactant instillation catheter (MIST) 16G Angiocath (Becton Dickinson, Sandy, UT, USA), at a dosage of 200 mg/kg as soon as possible after delivery (within 15 minutes).

Group II: Rescue Surfactant via Minimally Invasive TechniqueActive Control1 Intervention

The control group will be given surfactant will receive a dose of poractant alfa (Curosurf) administered under direct laryngoscopy using a surfactant instillation catheter (MIST) 16G Angiocath (Becton Dickinson, Sandy, UT, USA), at a dosage of 200 mg/kg if their fiO2 reaches a threshold of ≥30% within the first 48 hours of life.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

NorthShore University HealthSystemLead Sponsor

132 Previous Clinical Trials

737,458 Total Patients Enrolled

4 Trials studying Premature Birth

1,623 Patients Enrolled for Premature Birth

Chiesi USA, Inc.Industry Sponsor

8 Previous Clinical Trials

5,904 Total Patients Enrolled

Matthew Derrick, MBBSPrincipal InvestigatorNorthshore Univ Healthsystem

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any slots available to join this research endeavor?

"According to clinicaltrials.gov, this investigation is no longer recruiting patients at the present moment. The initial posting of the trial was on September 1st 2023 and there have been recent edits as recently as August 22nd 2023. Despite not being able to participate in this study currently, 446 other trials are available for enrollment across various sites."

Answered by AI

Does this research include geriatric individuals as participants?

"The age requisites for this research trial are between 0 Minutes and 15 Minutes. On clinicaltrials.gov, there is an abundance of other trials with 241 targeting those under 18 years old whereas 218 focus on seniors that are 65 and above."

Answered by AI

Could I potentially qualify to participate in this experiment?

"In order to be accepted into this trial, applicants must suffer from neonatal respiratory distress syndrome and should have been born between 0 minutes and 15 minutes. A total of 200 patients are needed for the study."

Answered by AI

What potential harm could be experienced by individuals undergoing the Minimally Invasive Technique of Prophylactic Surfactant?

"Our team at Power rated the safety of Prophylactic Surfactant via Minimally Invasive Technique a 3, which signifies that this phase 4 treatment has been officially sanctioned."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Prophylactic Minimally Invasive Surfactant Evaluation

Matthew Derrick 2024. "Prophylactic Minimally Invasive Surfactant Evaluation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06007547.