Evidence
Surveillance decision
We will not update the NICE guideline on intravenous (IV) fluid therapy in children and young people in hospital.
We will amend recommendation 1.4.7 on IV fluid type for routine maintenance in term neonates to specify the population that the recommendation refers to.
Reasons for the decision
New evidence was identified in the following areas:
-
hypertonic (more than 0.9%) versus isotonic (0.9%) sodium chloride for resuscitation
-
faster versus slower resuscitation fluid rate
-
smaller versus larger resuscitation fluid volume
-
standard versus restricted volumes for routine fluid maintenance
-
liberal versus restricted intraoperative maintenance infusion
-
balanced crystalloid versus 0.9% or 0.45% sodium chloride for maintenance infusion
-
isotonic (0.9%) versus hypotonic (less than 0.9%) sodium chloride for maintenance infusion
-
3.3% versus 5% dextrose for maintenance infusion.
However, the evidence in these areas did not indicate a need to update the guideline because results were either: consistent with existing recommendations, of limited relevance to the guideline, from single trials, or based on outcomes deemed not to be critical or important by the original guideline committee. No further evidence to indicate a need to change this conclusion arose during consultation on the decision not to update the guideline.
However, during consultation, stakeholders raised concerns in the following 2 areas which, although insufficient for an update of the guideline at this time, warranted further action as detailed below.
Fluid type for routine maintenance in term neonates
During consultation, a stakeholder expressed concerns about recommendation 1.4.7 on IV fluid type for routine maintenance in term neonates. The recommendation currently states: 'If term neonates need IV fluids for routine maintenance, initially use isotonic crystalloids that contain sodium in the range 131–154 mmol/litre with 5–10% glucose'. The stakeholder noted that the recommended ranges of sodium and glucose could lead to hypernatraemia or hypoglycaemia, particularly in younger neonates. For example, they stated that in the first 24 hours of life, plain (usually 10%) glucose without electrolytes is standard in term neonates.
Recommendation 1.4.7 is for all term neonates up to 28 days old and does not discuss the potential need for a different approach in babies in the first days of life. When the guideline was originally developed, the full guideline (page 107) notes some considerations from the guideline committee, including:
-
evidence suggested a clinical benefit of isotonic fluids for hyponatraemia in term neonates from 48 hours to 28 days
-
there was no evidence on fluid type specifically in term neonates from 0 hours to 48 hours
-
no evidence was identified in term neonates (0 hours to 48 hours, and 48 hours to 28 days) for the addition of glucose.
The committee therefore chose to use informal consensus to develop a recommendation.
No new evidence was identified by surveillance in this area, and the absence of new evidence contributed to the decision not to update the guideline we consulted on.
To further explore these issues because of potential safety concerns, we engaged with topic experts who were recruited to the NICE Centre for Guidelines Expert Advisers Panel to represent their specialty. We contacted 5 topic experts and received feedback from 3 (all consultant neonatologists). All 3 agreed that in the first 24 hours to 48 hours, 10% glucose is standard care, with 1 expert noting that sometimes 15% or 20% glucose is needed. Two experts felt there was a theoretical risk of hypoglycaemia with 5% glucose, and 2 experts agreed that isotonic crystalloids containing sodium in the range 131 to 154 mmol/litre would deliver excess sodium above usual requirements. One expert went on to note that newborns are managed within neonatal units, and fluid management for neonates in a neonatal intensive care unit or special care baby unit is very different to a paediatric setting.
The feedback from the stakeholder and topic experts indicated that the current wording of recommendation 1.4.7 may not correspond with current practice and may have safety implications including hypernatraemia and hypoglycaemia, particularly in younger neonates. It was therefore agreed that the recommendation should be amended. Three experts were asked about the population for whom recommendation 1.4.7, as currently worded, was most suitable, and 2 indicated that an appropriate cut-off would be term neonates aged 8 days or over. Because this would leave a gap for management of term neonates aged up to 7 days, it was further decided to add wording to the recommendation to cover this population.
Recommendation 1.4.7 will now state:
-
If term neonates aged 8 days or over need IV fluids for routine maintenance, initially use isotonic crystalloids that contain sodium in the range 131 to 154 mmol/litre with 5% to 10% glucose. For term neonates aged up to 7 days, use professional judgement, taking into account:
-
the individual circumstances and
-
for term neonates in the first days of life, that a sodium content of 131 to 154 mmol/litre may be too high (or sodium may not be needed), and a glucose content of 5% to 10% may be too low.
-
This issue will be logged, and we may revisit this area if we become aware of any relevant new evidence in future.
Balanced crystalloids versus 0.9% sodium chloride
Among the new evidence identified before consultation, some studies suggested that balanced crystalloids could have some benefits over 0.9% sodium chloride for both fluid resuscitation and fluid maintenance. The guideline currently recommends crystalloids containing 131 to 154 mmol/litre of sodium (of which balanced crystalloids and 0.9% sodium chloride are examples) for resuscitation and maintenance, but does not specify a particular fluid type. However, the new evidence on balanced crystalloids was from single trials in various conditions and most outcomes were not those deemed critical by the original guideline committee. Some studies also showed no benefit of balanced crystalloids over 0.9% sodium chloride. Overall, we did not find sufficient new evidence to support an update of the guideline in this area.
During consultation, a stakeholder disagreed with the proposal not to update the guideline regarding balanced crystalloids, noting that although the evidence is limited, there is some evidence of benefit, and no evidence of harm. We were also made aware (through an open letter to NICE) of 2 large randomised controlled trials (RCTs) that appear to demonstrate some benefits of balanced crystalloids over 0.9% sodium chloride in adults:
-
SMART trial 2018 (n=15,802 critically ill adults)
-
SALT-ED trial 2018 (n=13,347 noncritically ill adults).
No new evidence specifically in children was submitted during the consultation, and we therefore believe that evidence is not conclusive enough to specifically recommend balanced crystalloids over normal saline at this time, and the current recommendation allows for clinical judgement in selecting the most appropriate fluid type. However, we acknowledge that SMART and SALT‑ED are large RCTs that appear to demonstrate benefits of balanced crystalloids in adults. We therefore plan to conduct an exceptional surveillance review based on these studies. Because the studies are in adults, we will initially focus on any impact of the evidence on the NICE guideline on IV fluid therapy in adults in hospital. We will consider whether any changes are needed to recommendations on fluid type in NICE guideline NG29 as part of this process.
For further details and a summary of all evidence identified in surveillance, see appendix A.
This page was last updated: