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Enteral Nutrition Tolerance And REspiratory Support (ENTARES) Study in preterm infants: study protocol for a
Francesco Cresi1, Elena Maggiora2, Silvia Maria Borgione1
1Neonatal Pathology and Neonatal Intensive Care Unit, Università di Torino, Turin, Italy.
Insights
This study compares nasal continuous positive airway pressure (NCPAP) and heated humidified high-flow nasal cannula (HHHFNC) for respiratory distress syndrome (RDS) in preterm infants. Findings will guide optimal respiratory support for improved feeding tolerance and outcomes.
Area of Science:
- Neonatal Medicine
- Pediatric Respiratory Care
- Clinical Nutrition
Background:
- Respiratory distress syndrome (RDS) and feeding intolerance are leading causes of mortality in preterm infants.
- Traditional mechanical ventilation for RDS increases risks of lung injury and bronchopulmonary dysplasia.
- Nasal continuous positive airway pressure (NCPAP) and heated humidified high-flow nasal cannula (HHHFNC) are widely used non-invasive ventilation techniques.
Purpose of the Study:
- To evaluate the impact of NCPAP versus HHHFNC on enteral feeding in preterm infants with RDS.
- To identify the most suitable non-invasive ventilation technique for optimizing nutrition and reducing complications in this population.
- To assess the influence of these techniques on feeding tolerance and overall health status.
Main Methods:
- A multicenter, single-blind, randomized controlled trial design.
- Enrollment of preterm infants (25-29 weeks gestational age) with RDS requiring non-invasive support.
- Randomization to either NCPAP or HHHFNC arm, with monitoring until discharge and intention-to-treat analysis.
Main Results:
- Primary outcome: time to achieve full enteral feeding.
- Secondary outcomes: respiratory support parameters, feeding tolerance, and overall health status.
- Sample size calculated at 141 patients per arm for robust statistical power.
Conclusions:
- Identifying the optimal technique (NCPAP vs. HHHFNC) can reduce gastrointestinal complications and hospital stay.
- This research may improve growth and reduce healthcare costs for preterm infants with RDS.
- Evaluating feeding timing and response can inform understanding of sucking-swallow coordination and RDS treatment efficacy.
Background:
Respiratory distress syndrome (RDS) and feeding intolerance are common conditions in preterm infants and among the major causes of neonatal mortality and morbidity. For many years, preterm infants with RDS have been treated with mechanical ventilation, increasing risks of acute lung injury and bronchopulmonary dysplasia. In recent years non-invasive ventilation techniques have been developed. Showing similar efficacy and risk of bronchopulmonary dysplasia, nasal continuous positive airway pressure (NCPAP) and heated humidified high-flow nasal cannula (HHHFNC) have become the most widespread techniques in neonatal intensive care units. However, their impact on nutrition, particularly on feeding tolerance and risk of complications, is still unknown in preterm infants. The aim of the study is to evaluate the impact of NCPAP vs HHHFNC on enteral feeding and to identify the most suitable technique for preterm infants with RDS.
Methods:
A multicenter randomized single-blind controlled trial was designed. All preterm infants with a gestational age of 25-29 weeks treated with NCPAP or HHHFNC for RDS and demonstrating stability for at least 48 h along with the compliance with inclusion criteria (age less than 7 days, need for non-invasive respiratory support, suitability to start enteral feeding) will be enrolled in the study and randomized to the NCPAP or HHHFNC arm. All patients will be monitored until discharge, and data will be analyzed according to an intention-to-treat model. The primary outcome is the time to reach full enteral feeding, while parameters of respiratory support, feeding tolerance, and overall health status will be evaluated as secondary outcomes. The sample size was calculated at 141 patients per arm.
Discussion:
The identification of the most suitable technique (NCPAP vs HHHFNC) for preterm infants with feeding intolerance could reduce gastrointestinal complications, improve growth, and reduce hospital length of stay, thus improving clinical outcomes and reducing health costs. The evaluation of the timing of oral feeding could be useful in understanding the influence that these techniques could have on the development of sucking-swallow coordination. Moreover, the evaluation of the response to NCPAP and HHHFNC could clarify their efficacy as a treatment for RDS in extremely preterm infants.
Trial Registration:
ClinicalTrials.gov, NCT03548324 . Registered on 7 June 2018.
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