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Effect of nasogastric versus orogastric tube placement on ventilator-associated pneumonia incidence in critically ill patients: a study protocol for a cluster randomised crossover trial in 16 intensive care units in France (SONG trial)

Por: Saletes · J. · Guitton · C. · Valleroy · J. · Guillarme · S. · Haubertin · C. · Paris · G. · Muller · L. · Rousseau · C. · Gamon · P. · LHotellier · S. · Forel · J.-M. · Roussel · C. · Garin · A. · Morand · C. · Maury · E. · Mangeard · N. · Menard · L. · Arnaud · P.-Y. · Lejeune · A. · Rouan
Introduction

Patients in intensive care units (ICUs) frequently require mechanical ventilation, with approximately half needing invasive ventilation through an orotracheal tube. For these patients, gastric tube (GT) insertion is routinely performed to administer nutrition and medications or to drain gastric contents. The insertion route (oral or nasal) may affect the incidence of ventilator-associated pneumonia (VAP), a significant ICU care complication. This study aims to compare the impact of oral versus nasal GT insertion on the incidence of VAP in intubated ICU patients.

Methods and analysis

The SONG trial (NCT 05915663) is a multicentre, open-label, two-period, two-intervention, cluster randomised crossover superiority trial. 16 French ICUs will participate. ICUs will be randomised to periods of nasogastric or orogastric tube placement. The trial includes a practice standardisation period, followed by two 12-month inclusion periods separated by a monitoring and washout period. The primary endpoint is the incidence rate of VAP at day 28, confirmed by three independent physicians. Secondary endpoints include the ease of GT insertion, measured by the number of attempts.

Ethics and dissemination

This study received approval from a central ethical review board on 12 April 2024 (CPP Sud-est VI, registration number 23.00943.000175). Patients are included after informed consent or, when not possible, from next of kin. If none are available, the investigator will proceed with emergency inclusion, following French law. When consent is initially obtained from the next of kin or through emergency inclusion, the investigator will seek consent from the patient as soon as possible. Data will be anonymised and patient confidentiality maintained. Results will be published in peer-reviewed journals and presented at scientific meetings.

Trial registration number

NCT05915663.

Impact assessment of Benazir Nashonuma Programme (BNP) on maternal, child health and nutritional status in Pakistan: a quasi-experimental study protocol

Por: Muhammad · S. · Malik · A. A. · Soofi · S. · Habib · A. · Umer · M. · Rizvi · A. · Ahmed · I. · Leroy · J. · Cousens · S. · Bhutta · Z. A.
Introduction

Maternal and child malnutrition is a significant public health concern in Pakistan, with 40% of children under five being stunted. In response, the Government of Pakistan initiated the Benazir Nashonuma Programme (BNP), a nutritional supplementation programme for pregnant women, mothers of children aged 0 to 23 months and children aged 6 to 24 months. This study aims to evaluate the effectiveness of the BNP in reducing childhood stunting and improving maternal and child health outcomes.

Methods and analysis

A quasi-experimental longitudinal study comprising baseline, midline and endline surveys will be conducted across 18 districts (9 intervention and 9 control) in Pakistan. The surveys will use a two-stage cluster sampling method to enrol 13 200 children aged 0–59 months and their mothers from the Benazir Income Support Programme households. The primary outcome of interest is the prevalence of under-five stunting. We will use a difference-in-differences approach to estimate the impact by comparing the documented changes over time between the intervention and control groups.

Ethics and dissemination

This study will provide critical insights into the effectiveness of the BNP in addressing childhood undernutrition in Pakistan. The findings will inform policy and programmatic decisions aimed at reducing undernutrition in resource-constrained settings. Ethical approval has been obtained from the Ethics Review Committee of Aga Khan University and the Pakistan National Bioethics Committee.

Trial registration number

NCT06025786.

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