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Early Caffeine + LISA vs. CPAP for Neonatal Respiratory Distress Syndrome (CaLI Trial)

N/A

Waitlist Available

Led By Anup Katheria

Research Sponsored by Sharp HealthCare

Eligibility Criteria Checklist

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

Must have

Infant is spontaneously breathing on CPAP of 5-8 cmH2O and maintaining a normal heart rate (HR>100 Bpm)

Premature infants born at 24 to 29+6 weeks gestation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years of corrected gestational age

Awards & highlights

CaLI Trial Summary

This trial is testing if surfactant given early can reduce the need for mechanical ventilation in the first 3 days of life, compared to just using CPAP.

Who is the study for?

This trial is for premature infants born between 24 and just under 30 weeks of gestation. They must be breathing on their own with CPAP support and have a normal heart rate. Infants can't join if they have birth defects, didn't get parental consent, or needed intubation right after birth due to instability.Check my eligibility

What is being tested?

The study compares two treatments for preterm lung problems: one group receives surfactant through the Less Invasive Surfactant Administration (LISA) method, while the other gets early Continuous Positive Airway Pressure (CPAP) alone to see which reduces mechanical ventilation need within the first 72 hours of life.See study design

What are the potential side effects?

Potential side effects may include discomfort from CPAP masks or nasal prongs, irritation in airways from LISA procedure, and general risks associated with handling preterm infants such as infections or delayed growth.

CaLI Trial Eligibility Criteria

Inclusion Criteria

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

Select...

My infant breathes on their own with CPAP support and has a normal heart rate.

Select...

My baby was born prematurely between 24 and just under 30 weeks.

CaLI Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years of corrected gestational age

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years of corrected gestational age

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years of 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

Intubation, Intratracheal

Secondary outcome measures

Duration of mechanical ventilation and/or CPAP

Frequency of Grade III and IV intraventricular hemorrhage

Need for repeat surfactant dosing

+3 more

Other outcome measures

Intubation, Intratracheal

Laryngoscopy attempt with the LISA procedure

CaLI Trial Design

2Treatment groups

Active Control

Group I: Less Invasive Surfactant Administration (LISA)Active Control1 Intervention

Infants that are spontaneously breathing with a normal heart rate will be randomized to receive prophylactic surfactant (Curosurf 2.5 mL/kg, based on estimated fetal weight) by the LISA procedure in the first 2 hours of life, using a conventional or video laryngoscope and a small flexible 16 gauge angiocatheter. Any repeat dosing for surfactant will be based on clinical indication at the physician discretion by the conventional endotracheal approach.

Group II: Continuous Positive Airway Pressure (CPAP)Active Control1 Intervention

Infants that are spontaneously breathing with a normal heart rate will be randomized to early Continuous Positive Airway Pressure (CPAP).

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Sharp HealthCareLead Sponsor

40 Previous Clinical Trials

16,964 Total Patients Enrolled

1 Trials studying Respiratory Distress Syndrome

80 Patients Enrolled for Respiratory Distress Syndrome

Sharp Mary Birch Hospital for Women & NewbornsOTHER

12 Previous Clinical Trials

6,362 Total Patients Enrolled

University of California, IrvineOTHER

542 Previous Clinical Trials

1,921,821 Total Patients Enrolled

Media Library

Continuous Positive Airway Pressure CPAP Clinical Trial Eligibility Overview. Trial Name: NCT04209946 — N/A

Respiratory Distress Syndrome Research Study Groups: Less Invasive Surfactant Administration (LISA), Continuous Positive Airway Pressure (CPAP)

Respiratory Distress Syndrome Clinical Trial 2023: Continuous Positive Airway Pressure CPAP Highlights & Side Effects. Trial Name: NCT04209946 — N/A

Continuous Positive Airway Pressure CPAP 2023 Treatment Timeline for Medical Study. Trial Name: NCT04209946 — N/A

Frequently Asked Questions

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

Are adults aged 50 and over eligible for inclusion in this trial?

"As outlined in the study's entrance criteria, only infants aged between 24 and 29 weeks can be enrolled."

Answered by AI

Is membership in this medical study open to me?

"This medical research initiative is recruiting 180 premature infants, born between 24 weeks and 29+6 weeks gestation, who are suffering from respiratory distress syndrome (RDS). Other prerequisites for enrolment include parental consent as well as the presence of spontaneous breathing on CPAP with a pressure level ranging from 5 to 8 cmH2O. Additionally, each infant must have a heart rate higher than 100 beats per minute."

Answered by AI

Are additional participants being welcomed for this experiment?

"Confirmed, the clinical trial is still actively seeking participants. This medical investigation was first posted on January 22th 2020 and its details were recently updated on August 26th 2022."

Answered by AI

What is the highest possible cap of individuals engaging in this medical research?

"Confirmed. According to the data hosted on clinicaltrials.gov, this research study is actively searching for participants who were initially recruited on January 22nd 2020 and recently updated as of August 26th 2022. The team aims to enrol 180 patients across 3 sites in total."

Answered by AI

Recent research and studies

Acta PaediatricaJournal

Survey of Less Invasive Surfactant Administration in England, Slow Adoption and Variable Practice

Bhayat, Sadaf, Avineet Kaur, Irnthu Premadeva, Peter Reynolds, and Harsha Gowda. 2019. “Survey of Less Invasive Surfactant Administration in England, Slow Adoption and Variable Practice”. Acta Paediatrica. Wiley. doi:10.1111/apa.14995.

The LancetJournal

Avoidance of Mechanical Ventilation by Surfactant Treatment of Spontaneously Breathing Preterm Infants (AMV): An Open-label, Randomised, Controlled Trial

Göpel, Wolfgang, Angela Kribs, Andreas Ziegler, Reinhard Laux, Thomas Hoehn, Christian Wieg, Jens Siegel, et al.. 2011. “Avoidance of Mechanical Ventilation by Surfactant Treatment of Spontaneously Breathing Preterm Infants (AMV): An Open-label, Randomised, Controlled Trial”. The Lancet. Elsevier BV. doi:10.1016/s0140-6736(11)60986-0.

Journal of PerinatologyJournal

The Use of Less Invasive Surfactant Administration (LISA) in the United States with Review of the Literature

Kurepa, Dalibor, Shahana Perveen, Yisrael Lipener, and Venkatakrishna Kakkilaya. 2019. “The Use of Less Invasive Surfactant Administration (LISA) in the United States with Review of the Literature”. Journal of Perinatology. Springer Science and Business Media LLC. doi:10.1038/s41372-018-0302-9.

Klinische PädiatrieJournal