One-third lost to follow-up leaves the HeLP wrap outcome unresolved

Death or neurodevelopmental disability at 18 to 24 months occurred in 82/113 infants assigned to occlusive wrap and 80/127 assigned to control (OR 1.55, 95% CI 0.90 to 2.69). Because 116/356 infants had no known primary outcome, disproportionately from the wrap group, this report cannot establish equivalent long-term outcomes or determine whether there is harm.

The hot take

Among infants with known outcomes at 18 to 24 months, death or neurodevelopmental disability occurred in 82/113 (72.6%) assigned to occlusive wrap and 80/127 (63.0%) assigned to control. The odds ratio was 1.55 (95% CI 0.90 to 2.69), but 116/356 infants had no known primary outcome. This is an unresolved estimate, not evidence that long-term outcomes were equivalent.

The absolute risk difference was +10.9 percentage points (95% CI -2.4 to +24.2), with Fisher exact p = 0.115. The interval includes no difference and a potentially important higher event rate after wrap assignment. A nonsignificant p value does not prove no effect.

What was studied

This is long-term follow-up of the HeLP randomized program, not a new intervention trial. The original study assigned infants born before 28 weeks across 39 centers to polyethylene occlusive wrap or no wrap immediately after birth. Neurodevelopment was a protocol-specified major secondary outcome, but only 11 centers had formal perinatal follow-up programs. Those centers contributed 356 randomized infants, 183 assigned to wrap and 173 to control.