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Study protocol: treatment with caffeine of the very preterm infant in the delivery room: a feasibility study.

ABSTRACT: Introduction: Early treatment with caffeine in the delivery room has been proposed to decrease the need for mechanical ventilation (MV) by limiting episodes of apnoea and improving respiratory mechanics in preterm infants. Thus, the purpose of this feasibility study is to verify the hypothesis that intravenous or enteral administration of caffeine can be performed in the preterm infant in the delivery room.

Methods and analysis: In this multicentre prospective study, infants with 25⁺⁰-29⁺⁶ weeks of gestational age will be enrolled and randomised to receive 20?mg/kg of caffeine citrate intravenously, via the umbilical vein, or enterally, through an orogastric tube, within 10?min of birth. Caffeine plasma level will be measured at 60±15?min after administration and 60±15?min before the next dose (5?mg/kg). The primary endpoint will be evaluation of the success rate of intravenous and enteral administration of caffeine in the delivery room. Secondary endpoints will be the comparison of success rate of intravenous versus oral administration and the evaluation of the need for MV in treated infants. In the absence of previous references, we arbitrarily decided to study 20 infants treated with intravenous caffeine and 20 infants treated with enteral caffeine. Primary endpoint will be evaluated measuring the success rate of intravenous and enteral caffeine administration which will be considered a success when it is followed by the achievement of the caffeine therapeutic level (8-25?µg/mL) 60±15?min before administration of the second dose.

Ethics and dissemination: The study has been approved by the Italian Medicines Agency (AIFA: AIFA/RSC/P/32755) and by Comitato Etico Pediatrico Regione Toscana. The results will be published in peer-reviewed academic journals.

Trial registration number: ClinicalTrials.gov identifier NCT04044976; EudraCT number 2018-003626-91.

SUBMITTER: Dani C

PROVIDER: S-EPMC7722383 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

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Study protocol: treatment with caffeine of the very preterm infant in the delivery room: a feasibility study.

Dani Carlo C Cecchi Alessandra A Remaschi Giulia G Mercadante Domenica D la Marca Giancarlo G Boni Luca L Mosca Fabio F

BMJ open 20201204 12

<h4>Introduction</h4>Early treatment with caffeine in the delivery room has been proposed to decrease the need for mechanical ventilation (MV) by limiting episodes of apnoea and improving respiratory mechanics in preterm infants. Thus, the purpose of this feasibility study is to verify the hypothesis that intravenous or enteral administration of caffeine can be performed in the preterm infant in the delivery room.<h4>Methods and analysis</h4>In this multicentre prospective study, infants with 25 ...[more]

PMID: 33277284

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Project description:BackgroundChildren born preterm may display cognitive, learning, and behaviour difficulties as they grow up. In particular, very premature birth (gestation age between 28 and less than 32 weeks) may put infants at increased risk of intellectual deficits and attention deficit disorder. Evidence suggests that the basis of these problems may lie in difficulties in the development of executive functions. One of the earliest executive functions to emerge around 1 year of age is the ability to control attention. An eye-tracking-based cognitive training programme to support this emerging ability, the Attention Control Training (ACT), has been developed and tested with typically developing infants. The aim of this study is to investigate the feasibility of using the ACT with healthy very preterm (VP) infants when they are 12 months of age (corrected age). The ACT has the potential to address the need for supporting emerging cognitive abilities of VP infants with an early intervention, which may capitalise on infants' neural plasticity.Methods/designThe feasibility study is designed to investigate whether it is possible to recruit and retain VP infants and their families in a randomised trial that compares attention and social attention of trained infants against those that are exposed to a control procedure. Feasibility issues include the referral/recruitment pathway, attendance, and engagement with testing and training sessions, completion of tasks, retention in the study, acceptability of outcome measures, quality of data collected (particularly, eye-tracking data). The results of the study will inform the development of a larger randomised trial.DiscussionSeveral lines of evidence emphasise the need to support emerging cognitive and learning abilities of preterm infants using early interventions. However, early interventions with preterm infants, and particularly very preterm ones, face difficulties in recruiting and retaining participants. These problems are also augmented by the health vulnerability of this population. This feasibility study will provide the basis for informing the implementation of an early cognitive intervention for very preterm infants.Trial registrationRegistered Registration ID: NCT03896490. Retrospectively registered at Clinical Trials Protocol Registration and Results System (clinicaltrials.gov).

Dataset Information

Study protocol: treatment with caffeine of the very preterm infant in the delivery room: a feasibility study.

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Study protocol: treatment with caffeine of the very preterm infant in the delivery room: a feasibility study.

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