Dextrose gel at birth made no difference by school age

Design

school-age follow-up of a multicentre, double-blind, placebo-controlled randomised trial

Population

1067 children born at 35 or more weeks with a risk factor for transitional neonatal hypoglycaemia, assessed at 6 to 7 years

Primary outcome

neurocognitive impairment, defined as more than 1 SD below the normative mean on 1 or more of 7 NIH Toolbox items

Effect

59% vs 57%, adjusted risk difference 3% (95% CI -3% to 9%), p=0.36; emotional-behavioural difficulty 24% vs 18%

The hPOD trial gave a single 0.2 g/kg dose of buccal dextrose gel or placebo at one hour of age to infants born at 35 weeks or more with a risk factor for transitional hypoglycaemia. This is the follow-up at 6 to 7 years, assessed mostly in the children's schools: 532 in the gel group and 535 in the placebo group.

Neurocognitive impairment - a score more than 1 SD below the normative mean on any of seven NIH Toolbox items - occurred in 59% on gel and 57% on placebo, adjusted risk difference 3% (95% CI -3% to 9%). Among eleven exploratory outcomes, two favoured placebo: emotional-behavioural difficulty 24% against 18%, and low psychosocial function 17% against 12%.

Prophylactic dextrose gel has spread on the strength of short-term glucose and admission outcomes, which is a reasonable basis to try something and a poor basis to keep doing it. The long-term outcome the practice was ultimately meant to protect has now been measured and did not move. The behavioural signals should be read cautiously - they are two positives among eleven exploratory comparisons - but they are not a reason to continue either. Treating established hypoglycaemia with dextrose gel is a separate question that this trial does not address.

• This is about prophylaxis in at-risk but normoglycaemic infants, not about treating a documented low glucose
• Keep the core of risk-based care: early feeding, skin-to-skin contact, and glucose monitoring on a defined schedule
• Note the 57% impairment rate in the placebo arm - this at-risk population does poorly regardless, which is the more important finding
• Do not present dextrose gel prophylaxis to parents as protecting the brain

The statistics, in plain English

An adjusted risk difference of 3% with an interval from -3% to 9% includes zero, so no effect was shown; the interval is narrow enough to exclude a large benefit but not a small one. The two adverse exploratory findings need the multiplicity warning: with eleven exploratory outcomes tested, one or two crossing significance by chance is expected, and both intervals here reach close to zero at their lower end (1% to 12% and 1% to 10%). They are hypothesis-generating. The definition of impairment - more than 1 SD below the normative mean on any one of seven measures - is deliberately broad, which is why 57% of the placebo group met it; that figure describes the definition as much as the children.

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