多中心、随机临床试验比较早产儿接受咖啡因和较少侵入性表面活性剂给药与咖啡因和早期持续气道正压通气（CaLI 试验）：研究方案。

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.

机构信息

Neonatal Research Institute, Sharp Mary Birch Hospital for Women and Newborns, San Diego, California, USA.

Neonatology, Sharp Mary Birch Hospital for Women and Newborns, San Diego, California, USA.

出版信息

BMJ Open. 2021 Jan 22;11(1):e038343. doi: 10.1136/bmjopen-2020-038343.

DOI:10.1136/bmjopen-2020-038343

PMID:33483435

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7825253/

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 (FiO), 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 FiO >0.40 required to maintain saturations 90%-95% for 2 hours after randomisation; (2) a pH of 7.15 or less or a paCO >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.

摘要

介绍

呼吸窘迫综合征（RDS）或表面活性剂缺乏症主要发生在早产儿中，导致死亡或支气管肺发育不良的复合结局。早产儿 RDS 的初始管理策略包括早期开始持续气道正压通气（CPAP）和调整吸入氧分数（FiO），并可能包括使用较少侵入性的表面活性剂给药（LISA）以避免需要机械通气。为了优化无创支持的成功率，早期使用咖啡因治疗对于 LISA 的成功可能至关重要。我们的试验目的是评估通过 LISA 方法接受早期咖啡因、CPAP 和表面活性剂治疗的婴儿与仅接受咖啡因和 CPAP 治疗的婴儿相比，在生命的前 72 小时内是否需要减少有创机械通气。

方法和分析

CaLI 是一项多中心、随机对照、盲法试验，纳入 180 例早产儿（24+0-29+6 周校正胎龄）。插管/治疗失败的标准将遵循 RDS 管理指南，包括：（1）CPAP 水平为 6-8cmH20，FiO>0.40，随机化后 2 小时内维持饱和度 90%-95%；（2）任何 2 次血气（动脉/毛细血管/静脉）的 pH 值为 7.15 或更低或 paCO2>65mmHg，随机化后至少 2 小时且在生命的前 72 小时内；（3）持续出现呼吸暂停/心动过缓/脱氧事件，尽管采用经鼻间歇正压通气通气模式。婴儿将在生命的 1 小时内随机分组，咖啡因/LISA 治疗将在生命的 2 小时内给予。LISA 组中咖啡因将在表面活性剂之前给予，对照组中在生命的 2 小时之前给予。