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Outcomes following early parenteral nutrition use in preterm neonates: protocol for an observational study
James Webbe1, Nicholas Longford1, Sabita Uthaya1
1Section of Neonatal Medicine, Imperial College London, London, UK.
Insights
This study examines early parenteral nutrition (PN) use in preterm infants in the UK. It investigates if early PN administration impacts survival and other neonatal outcomes for babies born between 30 and 32 weeks gestation.
Area of Science:
- Neonatal medicine
- Clinical research
- Pediatric nutrition
Background:
- Parenteral nutrition (PN) is crucial for preterm infants, but its early use varies widely.
- Emerging evidence suggests potential harms, like increased infections, may outweigh benefits of early PN in critically ill patients.
- Uncertainty exists regarding which preterm infant groups benefit most from early PN introduction.
Purpose of the Study:
- To describe current practices of early PN administration in neonatal units across England, Wales, and Scotland.
- To evaluate the association between early PN use and key neonatal outcomes in moderately preterm infants (30-32 weeks gestation).
- To compare survival to discharge and other core neonatal outcomes between infants receiving early PN and those who do not.
Main Methods:
- Utilizing routinely collected data from the National Neonatal Research Database (NNRD) for infants born between January 2012 and December 2017.
- Describing PN use within the first 7 postnatal days for all admitted neonates.
- Employing a propensity score-matched approach to compare outcomes for moderately preterm infants (30-32 weeks gestation) with and without early PN.
Main Results:
- Data analysis is ongoing; results will be disseminated following study completion.
- The study will report on the primary outcome of survival to discharge.
- Secondary outcomes, including the neonatal core outcome set, will be analyzed.
Conclusions:
- Findings will inform clinical guidelines on the optimal timing and use of PN in moderately preterm infants.
- This research aims to clarify the risks and benefits of early PN, guiding evidence-based neonatal care.
- Dissemination will include academic conferences and patient advocacy groups like Bliss.
Introduction:
Preterm babies are among the highest users of parenteral nutrition (PN) of any patient group, but there is wide variation in commencement, duration, and composition of PN and uncertainty around which groups will benefit from early introduction. Recent studies in critically unwell adults and children suggest that harms, specifically increased rates of nosocomial infection, outweigh the benefits of early administration of PN. In this study, we will describe early PN use in neonatal units in England, Wales and Scotland. We will also evaluate if this is associated with differences in important neonatal outcomes in neonates born between 30+0 and 32+6 weeks+days gestation.
Methods And Analysis:
We will use routinely collected data from all neonatal units in England, Wales and Scotland, available in the National Neonatal Research Database (NNRD). We will describe clinical practice in relation to any use of PN during the first 7 postnatal days among neonates admitted to neonatal care between 1 January 2012 and 31 December 2017. We will compare outcomes in neonates born between 30+0 and 32+6 weeks+days gestation who did or did not receive PN in the first week after birth using a propensity score-matched approach. The primary outcome will be survival to discharge home. Secondary outcomes will include components of the neonatal core outcome set: outcomes identified as important by former patients, parents, clinicians and researchers.
Ethics And Dissemination:
We have obtained UK National Research Ethics Committee approval for this study (Ref: 18/NI/0214). The results of this study will be presented at academic conferences; the UK charity Bliss will aid dissemination to former patients and parents.
Trial Registration Number:
NCT03767634.
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