Dataset Information

Multicentre, randomised trial of preterm infants receiving caffeine and less invasive surfactant administration compared with caffeine and early continuous positive airway pressure (CaLI trial): study protocol.

ABSTRACT:

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.

SUBMITTER: Ines F

PROVIDER: S-EPMC7825253 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature

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Publications

Multicentre, randomised trial of preterm infants receiving caffeine and less invasive surfactant administration compared with caffeine and early continuous positive airway pressure (CaLI trial): study protocol.

Ines Felix F Hutson Shandee S Coughlin Katherine K Hopper Andrew A Banerji Anamika A Uy Cherry C Finer Neil N Rich Wade W Morales Ana A Steen Jane J Katheria Anup C AC

BMJ open 20210122 1

<h4>Introduction</h4>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 (FiO<sub>2</sub>), and may include the use of less invasive surfactant administration (LISA) to avoid the need for mechanical ventila ...[more]

PMID: 33483435

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Project description:BackgroundLess invasive surfactant administration (LISA) is a way of giving surfactant without endotracheal intubation and has shown to be promising in reducing the incidence of bronchopulmonary dysplasia (BPD) in preterm infants. However, the mechanism underlying its beneficial effect and variations in the technique of administration may prevent its widespread use. This trial aims to evaluate the effects of two methods of surfactant administration, LISA or endotracheal surfactant administration followed by low peak pressure (LPPSA) ventilation, in preterm infants with respiratory distress syndrome (RDS).MethodsThe LISA Or Low Peak Pressure trial is to be conducted in 14 tertiary neonatal intensive care units in China. A total of 600 preterm infants born with gestational age between 250/7 and 316/7 weeks and with a primary diagnosis of RDS will be involved in the study. Infants will be randomized to the LISA or LPPSA group when surfactant therapy is indicated. Primary outcomes include mortality, severity of bronchopulmonary dysplasia at 36 weeks of postmenstrual age (PMA), and mechanical ventilation (MV) in the first 72 h of life. Secondary outcomes include the days of MV, duration of all sorts of non-invasive respiratory support, fraction of inspired oxygen, oxygen saturation before and after surfactant administration, and time required to perform the procedure for surfactant administration. The incidence of comorbidities, including retinopathy of prematurity (ROP), necrotizing enterocolitis (NEC), intraventricular hemorrhage (IVH), hemodynamically significant patent ductus arteriosus (hsPDA), pneumothorax, and massive pulmonary hemorrhage within 48 h of surfactant administration, and the failure rates of each technique will be determined.DiscussionData from recent systematic review and meta-analysis have suggested a possible improvement in outcomes of preterm infants with RDS by the LISA technique. However, robust evidence is lacking. Why LISA plays a potential role in reducing respiratory morbidity, mainly BPD in preterm infants, remains unclear. The possible explanations are the active and uninterrupted delivery of continuous positive airway pressure during the LISA procedure and the avoidance of complications caused by intubation and relatively high pressure/volume ventilation following surfactant administration. We hypothesized that LISA's effectiveness lies mainly in avoiding relatively high-pressure positive ventilation immediately following surfactant administration. Thus, this multicenter randomized controlled trial will focus on issues of endotracheal intubation and the pressure/volume used during conventional surfactant administration. The effectiveness, safety and comorbidities of preterm infants following LISA or LPPSA will be evaluated.Trial registrationChinese Clinical Trial Registry: ChiCTR1900020970. Registered on 23 January 2019.

Project description:BackgroundExtremely preterm infants are often exposed to endotracheal tube continuous positive airway pressure (ETT-CPAP) trials to assess extubation readiness. The effects of ETT-CPAP trial on their diaphragmatic activity (Edi) and breathing variability is unknown.MethodsProspective observational study enrolling infants with birth weight ≤1250 g undergoing their first extubation attempt. Diaphragmatic activity, expressed as the absolute minimum (Edi min) and maximum values (Edi max), area under the Edi signal, and breath-by-breath analyses for breath areas, amplitudes, widths, and neural inspiratory and expiratory times, were analyzed during mechanical ventilation (MV) and ETT-CPAP. Neural breathing variability of each of these parameters was also calculated and compared between MV and ETT-CPAP.ResultsThirteen infants with median (interquartile range) birth weight of 800 g [610-920] and gestational age of 25.4 weeks [24.4-26.3] were included. Diaphragmatic activity significantly increased during ETT-CPAP when compared to MV:Edi max (44.2 vs. 38.1 μV), breath area (449 vs. 312 μV·s), and amplitude (10.12 vs. 7.46 μV). Neural breathing variability during ETT-CPAP was characterized by increased variability for amplitude and area under the breath, and decreased for breath time and width.ConclusionsA 5-min ETT-CPAP in extremely preterm infants undergoing extubation imposed significant respiratory load with changes in respiratory variability.ImpactETT-CPAP trials are often used to assess extubation readiness in extremely preterm infants, but its effects upon their respiratory system are not well known. Diaphragmatic activity analysis demonstrated that these infants are able to mount an important response to a short trial. A 5-min trial imposed a significant respiratory load evidenced by increased diaphragmatic activity and changes in breathing variability. Differences in breathing variability were observed between successful and failed extubations, which should be explored further in extubation readiness investigations. This type of trial cannot be recommended for preterm infants in clinical practice until clear standards and accuracy are established.

Dataset Information

Multicentre, randomised trial of preterm infants receiving caffeine and less invasive surfactant administration compared with caffeine and early continuous positive airway pressure (CaLI trial): study protocol.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

Multicentre, randomised trial of preterm infants receiving caffeine and less invasive surfactant administration compared with caffeine and early continuous positive airway pressure (CaLI trial): study protocol.

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