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Published on: January 7, 2020
Multicentre, randomised trial of preterm infants receiving caffeine and less invasive surfactant administration
Felix Ines1, Shandee Hutson2, Katherine Coughlin2
1Neonatal Research Institute, Sharp Mary Birch Hospital for Women and Newborns, San Diego, California, USA.
Insights
Early caffeine therapy combined with less invasive surfactant administration (LISA) and continuous positive airway pressure (CPAP) may reduce mechanical ventilation needs in preterm infants with respiratory distress syndrome (RDS). This trial investigates the efficacy of this combined approach for improved respiratory support in neonates.
Area of Science:
- Neonatal Medicine
- Respiratory Physiology
- Clinical Trials
Background:
- Respiratory distress syndrome (RDS) is a significant cause of mortality and morbidity in premature infants.
- Current management involves continuous positive airway pressure (CPAP) and fractional inspired oxygen (FiO2), with less invasive surfactant administration (LISA) as an option to avoid mechanical ventilation.
- Early caffeine therapy is hypothesized to enhance the success of non-invasive respiratory support strategies like LISA.
Purpose of the Study:
- To evaluate if early caffeine therapy, CPAP, and LISA reduce the need for invasive mechanical ventilation in preterm infants with RDS within the first 72 hours of life.
- To compare the efficacy of early caffeine, CPAP, and LISA versus caffeine and CPAP alone in managing RDS.
Main Methods:
- A multicentre, unblinded, randomized controlled trial (CaLI) involving 180 preterm infants (24+0-29+6 weeks corrected gestational age).
- Infants randomized within 1 hour of life, with treatments initiated by 2 hours.
- Treatment failure criteria include high CPAP/FiO2 requirements, specific blood gas derangements, or persistent cardiorespiratory events despite nasal intermittent minute ventilation.
Main Results:
- This is a pre-results abstract; therefore, main results are not yet available.
- The trial is registered on ClinicalTrials.gov (NCT04209946).
Conclusions:
- The study aims to determine if a combination of early caffeine, CPAP, and LISA can optimize non-invasive respiratory support for preterm infants.
- Findings are expected to inform clinical practice regarding the management of RDS in extremely preterm neonates.
Introduction:
Respiratory distress syndrome (RDS) or surfactant deficiency occurs primarily in premature infants resulting in composite outcomes of death or bronchopulmonary dysplasia. Initial management strategies for preterm infants with RDS includes early initiation of continuous positive airway pressure (CPAP) and titration of fractional inspired oxygen (FiO2), and may include the use of less invasive surfactant administration (LISA) to avoid the need for mechanical ventilation. In order to optimise success of non-invasive support, the use of early caffeine therapy may be critical to the success of LISA. The objective of our trial is to evaluate whether infants that receive early caffeine, CPAP and surfactant via the LISA method compared with infants that receive caffeine and CPAP alone, have a decreased need for invasive mechanical ventilation in the first 72 hours of life.
Methods And Analysis:
CaLI is an unblinded multicentre, randomised controlled, trial of 180 preterm infants (24+0-29+6 weeks corrected GA). Criteria for intubation/treatment failure will follow guidelines for the management of RDS, including: (1) CPAP level of 6-8 cmH20 and FiO2 >0.40 required to maintain saturations 90%-95% for 2 hours after randomisation; (2) a pH of 7.15 or less or a paCO2 >65 mm Hg on any (2) blood gases (arterial/capillary/or venous) at least 2 hours after randomisation and in the first 72 hours of life; (3) continued apnoea/bradycardia/desaturation events despite nasal intermittent minute ventilation mode of ventilation. Infants will be randomised by 1 hour of life and caffeine/LISA treatments administered by 2 hour of life. Caffeine will be administered prior to surfactant in the LISA arm and before 2 hours of life in the control arm.
Ethics And Dissemination:
Chiesi Farmaceutici, S.p.A is the sponsor of CaLI. Ethical approval has been obtained. Results will be submitted for publication in peer reviewed journals.
Trial Registration Number:
www.Clinicaltrials.gov: NCT04209946; Pre-results.
