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Early Caffeine and LISA Compared to Caffeine and CPAP in Preterm Infants (CaLI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04209946
Recruitment Status : Recruiting
First Posted : December 24, 2019
Last Update Posted : March 20, 2020
Sponsor:
Collaborators:
Sharp Mary Birch Hospital for Women & Newborns
Loma Linda University
Information provided by (Responsible Party):
Anup Katheria, M.D., Sharp HealthCare

Brief Summary:
This study is being conducted to determine whether prophylactic administration of surfactant by the Less Invasive Surfactant Administration (LISA) method reduces the need for mechanical ventilation in the first 72 hours of life when compared to early Continuous Positive Airway Pressure (CPAP) alone.

Condition or disease Intervention/treatment Phase
Premature Lungs Respiratory Distress Syndrome Surfactant Deficiency Syndrome Neonatal Procedure: Less Invasive Surfactant Administration LISA Procedure: Continuous Positive Airway Pressure CPAP Not Applicable

Detailed Description:

After 5 minutes of life, consented infants that are assessed by a provider as clinically stable (i.e. HR> 100 bpm) and spontaneously breathing on CPAP will be randomized by computer generated randomization cards placed in opaque envelopes.

For infants not consented prior to birth, after 5 minutes of life and before 2 hours of life, postnatal consent may be obtained for any eligible infant admitted to the NICU and must be randomized and receive treatment prior to their two hours of age. Randomization will be stratified by gestational age (24-26+6 weeks and 27-29+6 weeks) and labeled as such on each envelope. Multiples will be randomized to the same treatment group for ease of consent and family considerations.

Infants randomized to LISA will receive surfactant (Curosurf 2.5 mL/kg, based on estimated fetal weight) given in the first 2 hours of life using a conventional or video laryngoscope and a small flexible 16 gauge angiocatheter.

All sites have agreed on using senior level physicians or practitioners that have prior experience with the LISA method. An orogastric tube will be placed into the stomach prior to laryngoscopy and the contents aspirated after the procedure to document any esophageal surfactant administration.

Infants randomized to early CPAP will be managed according to unit practice for preterm infants on CPAP.

As an unblinded trial it is critical that both groups are standardized to avoid bias towards one arm for intubation/treatment failure. Therefore, strict delivery room/NICU criteria will be used.

In the Delivery Room, criteria for intubation will be as specified in the Neonatal Resuscitation Program guidelines (7th Ed) and will include:

  1. Chest compressions
  2. Ineffective respiration
  3. Prolonged positive pressure ventilation (PPV)
  4. Prolonged hypoxia

In the Neonatal Intensive Care Unit (NICU), randomized infants in both groups will only be intubated if they meet strict failure criteria :

  1. FiO2> 0.40 required to maintain oxygen saturation >90% for 2 hours after randomization
  2. pH of 7.15 or less OR a partial pCO2 >65 mmHg on any (2) blood gas (arterial/capillary/ or venous) at least 2 hours after randomization in the first 72 hours of life.

Infants intubated prior to randomization will be excluded.

For pragmatic purposes sites will be able to use their standard approach for non-invasive ventilation (NCPAP at SMB and NIMV at LLU).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Multicenter, Randomized Trial of Preterm Infants Receiving Caffeine and Less Invasive Surfactant Administration Compared to Caffeine and Early Continuous Positive Airway Pressure (CaLI Trial)
Actual Study Start Date : January 22, 2020
Estimated Primary Completion Date : January 2025
Estimated Study Completion Date : June 2025


Arm Intervention/treatment
Active Comparator: Less Invasive Surfactant Administration (LISA)
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.
Procedure: Less Invasive Surfactant Administration LISA
Laryngoscopy with insertion of a small 16 gauge angiocatheter to administer FDA approved Surfactant, during spontaneous respirations.

Active Comparator: Continuous Positive Airway Pressure (CPAP)
Infants that are spontaneously breathing with a normal heart rate will be randomized to early Continuous Positive Airway Pressure (CPAP).
Procedure: Continuous Positive Airway Pressure CPAP
Infant will remain on CPAP Therapy during spontaneous respirations




Primary Outcome Measures :
  1. Frequency of subjects requiring endotracheal intubation between the two groups (LISA vs CPAP) in the first 72 hours of life [ Time Frame: Within 72 hours of life ]
    Required intubation or meeting respiratory failure criteria of having a pCO2 greater than 65 mm Hg or an FiO2 greater than 0.4 for more than 2 hours in the first 72 hours of life


Secondary Outcome Measures :
  1. Duration of mechanical ventilation and/or CPAP [ Time Frame: Through study completion at discharge, up to 6 months of corrected gestational age ]
    Number of days on mechanical ventilation and/or CPAP

  2. Oxygen at 36 weeks corrected age [ Time Frame: Up to 40 weeks of corrected gestational age ]
    Requiring oxygen therapy greater than 0.21 at 36 weeks corrected age

  3. Frequency of Grade III and IV intraventricular hemorrhage [ Time Frame: Through study completion at discharge, up to 6 months of corrected gestational age ]
    Intraventricular hemorrhage (grades 3-4)

  4. Neurodevelopment outcome at 24 months of corrected gestational age [ Time Frame: Up to 2 years of corrected gestational age ]
    Neurodevelopmental assessments using the Bayley Scales of Infant Development 4th ed. will be done at 2 years of corrected corrected age (22-26 months) for subjects who were randomized at birth to receive surfactant by the LISA method versus CPAP alone.

  5. Need for repeat surfactant dosing [ Time Frame: Up to 40 weeks of corrected gestational age ]
    Requiring more than one dose of surfactant


Other Outcome Measures:
  1. Laryngoscopy attempt with the LISA procedure [ Time Frame: Number of laryngoscopy attempts per Surfactant dose, up to 36 weeks of corrected gestational age ]
    Total number of laryngoscopy attempts to administer surfactant via the LISA procedure

  2. Laryngoscopy attempt with endotracheal intubation [ Time Frame: Number of laryngoscopy attempts per Surfactant dose, up to 36 weeks of corrected gestational age ]
    Total number of laryngoscopy attempts to administer surfactant via endotracheal intubation



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Ages Eligible for Study:   24 Weeks to 29 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Premature infants born at 24 to 29+6 weeks gestation
  • Informed consent obtained (antenatal/postnatal)
  • Infant is spontaneously breathing and maintaining normal heart rate (HR>100 Bpm)

Exclusion Criteria:

  • Declined consent
  • Infants with known congenital anomalies
  • Requiring intubation prior to randomization

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04209946


Contacts
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Contact: Anup Katheria 858-939-4170 anup.katheria@sharp.com
Contact: Felix Ines 858-939-4136 felix.ines@sharp.com

Locations
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United States, California
Loma Linda Medical Center Not yet recruiting
Loma Linda, California, United States, 92350
Contact: Andrew Hopper, MD       AHopper@llu.edu   
Contact: Anamika Banerji, MD       ABanerji@llu.edu   
Sharp Mary Birch Hospital for Women & Newborns Recruiting
San Diego, California, United States, 92123
Contact: Anup Katheria, MD    858-939-4170    anup.katheria@sharp.com   
Contact: Felix Ines, RCP-RRT    858-939-4136    felix.ines@sharp.com   
Sub-Investigator: Shandee Hutson, MD         
Sponsors and Collaborators
Sharp HealthCare
Sharp Mary Birch Hospital for Women & Newborns
Loma Linda University
Investigators
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Principal Investigator: Anup Katheria Sharp HealthCare
Publications:

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Responsible Party: Anup Katheria, M.D., Director of Neonatal Research Institute, Sharp HealthCare
ClinicalTrials.gov Identifier: NCT04209946    
Other Study ID Numbers: CaLI
First Posted: December 24, 2019    Key Record Dates
Last Update Posted: March 20, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data, particularly data that underlie the results reported in this article after deidentification will be available with other researchers, including data dictionaries for meta-analysis.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Beginning 6 months and ending 36 months following article publication
Access Criteria: Data and publication are available at http://clinicaltrials.gov
URL: http://clinicaltrials.gov

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anup Katheria, M.D., Sharp HealthCare:
Premature Infants
Respiratory Distress Syndrome
Less Invasive Surfactant administration
Continuous Positive Airway Pressure (CPAP)
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Syndrome
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Pulmonary Surfactants
Respiratory System Agents