Isotonic versus hypotonic saline as maintenance intravenous fluid therapy in children under 5 years of age admitted to general paediatric wards: a randomised controlled trial

Abstract Background Intravenous fluid therapy represents the most common intervention critically ill patients are exposed to. Hyperchloremia and metabolic acidosis associated with 0.9% sodium chloride have been observed to lead to worse outcomes, including mortality. Balanced solutions, such as Plasma-Lyte 148 and Compound Sodium Lactate, represent potential alternatives but the evidence on optimal fluid choices in critically ill children remains scarce. This study aims to demonstrate whether balanced solutions, when used as intravenous fluid therapy, are able to reduce the incidence of a rise in serum chloride level compared to 0.9% sodium chloride in critically ill children. Methods This is a single-centre, open-label randomized controlled trial with parallel 1:1:1 assignment into three groups: 0.9% sodium chloride, Plasma-Lyte 148, and Compound Sodium Lactate solutions for intravenous fluid therapy. The intervention includes both maintenance and bolus fluid therapy. Children aged < 16 years admitted to intensive care and receiving intravenous fluid therapy during the first 4 h of admission are eligible. The primary outcome measure is a ≥ 5mmol/L increase in serum chloride level within 48 h post-randomization. The enrolment target is 480 patients. The main analyses will be intention-to-treat. Discussion This study tests three types of intravenous fluid therapy in order to compare the risk of hyperchloremia associated with normal saline versus balanced solutions. This pragmatic study is thereby assessing the most common intervention in paediatric critical care. This is a single-centre open-label study with no blinding at the level of delivery of the intervention. Certain paediatric intensive care unit (PICU) patient groups such as those admitted with a cardiac condition or following a traumatic brain injury are excluded from this study. Trial registration The study has received ethical approval (HREC/19/QCHQ/53177: 06/06/2019). It is registered in the Australian New Zealand Clinical Trials Registry (ACTRN12619001244190) from 9th September 2019. Recruitment commenced on 12th November 2019. The primary results manuscript will be published in a peer-reviewed journal.

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140 mmol/L of sodium versus 77 mmol/L of sodium in maintenance intravenous fluid therapy for children in hospital (PIMS): a randomised controlled double-blind trial

The Lancet ◽

10.1016/s0140-6736(14)61459-8 ◽

2015 ◽

Vol 385 (9974) ◽

pp. 1190-1197 ◽

Cited By ~ 73

Author(s):

Sarah McNab ◽

Trevor Duke ◽

Mike South ◽

Franz E Babl ◽

Katherine J Lee ◽

...

Keyword(s):

Fluid Therapy ◽

Intravenous Fluid ◽

Double Blind Trial ◽

Double Blind ◽

Intravenous Fluid Therapy ◽

Blind Trial ◽

Randomised Controlled

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Can child-focused sanitation and nutrition programming improve health practices and outcomes? Evidence from a randomised controlled trial in Kitui County, Kenya

BMJ Global Health ◽

10.1136/bmjgh-2018-000973 ◽

2019 ◽

Vol 4 (1) ◽

pp. e000973

Author(s):

Gerishom Gimaiyo ◽

Jeffery McManus ◽

Matt Yarri ◽

Shiva Singh ◽

Andrew Trevett ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Controlled Trial ◽

Child Outcomes ◽

Cluster Randomised Controlled Trial ◽

Child Undernutrition ◽

Hygiene Practices ◽

Households With Children ◽

Randomised Controlled ◽

The Impact ◽

Children Under 5

IntroductionIn Kenya’s Kitui County, 46% of children under 5 years are stunted. Sanitation and nutrition programmes have sought to reduce child undernutrition, though they are typically implemented separately. We evaluate the effectiveness of an integrated sanitation and nutrition (SanNut) intervention in improving caregiver sanitation and nutrition knowledge and behaviours.MethodsWe conducted a cluster-randomised controlled trial to evaluate the impact of the SanNut intervention on caregiver knowledge, sanitary and hygiene practices, sanitation outcomes and nutrition outcomes. The evaluation included caregivers of children under 5 years across 604 villages in Kitui County. 309 treatment villages were randomly assigned to receive both the SanNut intervention and the standard Community-Led Total Sanitation (CLTS) intervention, while 295 control villages only received the CLTS intervention. 8 households with children under 5 years were randomly selected from each evaluation village to participate in the endline survey, for a total of 4322 households.ResultsSanNut led to modest improvements in sanitary knowledge and practices emphasised by the programme. Caregivers in treatment villages were 3.3 pp (+32%) more likely to mention lack of handwashing after handling child faeces as a potential cause of diarrhoea, and 4.9 pp (+7.8%) more likely to report safe disposal of child faeces than caregivers in control villages. Treatment households were 1.9 pp (+79%) more likely to have a stocked handwashing station and 2.9 pp (−16%) less likely to report incidences of child diarrhoea. However, SanNut appears to have had no impact on nutritional practices, such as breastfeeding, vitamin A supplementation or deworming. Non-child outcomes traditionally associated with CLTS, including latrine use and homestead sanitary conditions, were similar in treatment and control groups.ConclusionChild-focused messaging can potentially be integrated into CLTS programming, though this integration was more successful for topics closer to CLTS objectives (sanitation practices, including limiting faecal contamination and handwashing) than for more disparate topics (nutritional practices).Trial registrationPan-African Clinical Trials Registry (PACTR201803003159346) and American Economic Association registry for randomised controlled trials (AEARCTR-0002019).

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