Summary

Location
at Irvine, California and other locations
Dates
study started
estimated completion

Description

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.

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)

Details

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. Caffeine Administration: If randomized to LISA, caffeine will be given prior to the LISA procedure. In contrast, if randomized to CPAP, caffeine will be given soon after birth. If infants in the CPAP group meet intubation criteria, and the loading dose of caffeine has not been administered, to avoid delay in intubation, caffeine will be given no later than thirty minutes after intubation. 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. CPAP level of 6-8 cmH2O and 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. 3. Continued Apnea/Bradycardia/Desaturation events despite nasal intermittent minute ventilation (NIMV) mode of ventilation. 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 or NIMV).

Keywords

Premature Lungs Respiratory Distress Syndrome Surfactant Deficiency Syndrome Neonatal Premature Infants Less Invasive Surfactant administration Continuous Positive Airway Pressure (CPAP) Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Syndrome Pulmonary Surfactants Less Invasive Surfactant Administration LISA Continuous Positive Airway Pressure CPAP Less Invasive Surfactant Administration (LISA)

Eligibility

You can join if…

  • Premature infants born at 24 to 29+6 weeks gestation
  • Informed consent obtained (antenatal/postnatal)
  • Infant is spontaneously breathing on CPAP of 5-8 cmH2O with an FiO2 of <.40 and maintaining a normal heart rate (HR>100 Bpm)

You CAN'T join if...

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

Locations

  • University of California, Irvine not yet accepting patients
    Irvine California 92868 United States
  • Loma Linda Medical Center not yet accepting patients
    Loma Linda California 92350 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Sharp HealthCare
ID
NCT04209946
Study Type
Interventional
Last Updated