Evidence map›Paper›PMID 42638093›Full record

Trial reportBMC pediatrics2026

Randomized trial of occlusive wrap for heat loss prevention in preterm infants: neurodevelopmental outcome.

Michael J Vincer, Maureen C Reilly, Sunita Vohra, Valeria E Rac, Zafira Bhaloo, Michael Dunn, Karla Ferrelli, Alex Kiss, John Wimmer, Denise Zayack and 2 more

Registry-linked trialAbstract readRandomized Controlled TrialMulticenter Study
PubMed Publisher
In one paragraph

Trial report in BMC pediatrics, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00607464 (Multicentre Randomised Controlled Trial of HELP), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00607464 naterminatednot on this map

Multicentre Randomised Controlled Trial of HELP (Heat Loss Prevention) in the Delivery Room

TypeinterventionalSponsorSunnybrook Health Sciences CentreRan2004 to 2012Enrolled804ConditionsHypothermia in Premature InfantsArmsPolyethylene occlusive skin wrap
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Michael J VincerDepartment of Pediatrics, Neonatal-Perinatal-Medicine, Dalhousie University, Halifax, NS, Canada. vincer@dal.ca.
Maureen C ReillyWomen and Babies Program, Sunnybrook Health Sciences Centre, Toronto, ON, Canada.
Sunita VohraDepartment of Pediatrics, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.
Valeria E RacWomen and Babies Program, Sunnybrook Health Sciences Centre, Toronto, ON, Canada.
Zafira BhalooDepartment of Pediatrics, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.
Michael DunnWomen and Babies Program, Sunnybrook Health Sciences Centre, Toronto, ON, Canada.
Karla FerrelliVermont Oxford Network, Burlington, VT, USA.
Alex KissDepartment of Research Design and Biostatistics, Sunnybrook Research Institute Toronto, Toronto, ON, Canada.
John WimmerNeonatology, Women's and Children's Center at Moses Cone Hospital, Greensboro, NC, USA.
Denise ZayackWomen and Babies Program, Sunnybrook Health Sciences Centre, Toronto, ON, Canada.
Roger SollVermont Oxford Network, Burlington, VT, USA.
Vermont Oxford Network HeLP Trial Study Group

Funding

Stollery Children's Hospital Foundation G599000746
6 · The paper itself

Abstract

backgroundHeat loss in the delivery room in very preterm infants is associated with increased mortality, hypothermia and other adverse outcomes. The Heat Loss Prevention (HeLP) trial resulted in a significant reduction of hypothermia but not a reduction in mortality. The HeLP follow-up trial was designed to determine whether application of occlusive wrap applied immediately after birth reduces adverse long-term neurodevelopmental outcomes at 18-24 months corrected gestational age in very preterm infants.

methodThe original HeLP trial was a randomized controlled trial in infants < 28 weeks gestation placed at birth in occlusive wrap (wrap group) or not placed in occlusive wrap (control group). The HeLP follow-up trial was the later assessment of these infants enrolled in the HeLP trial to determine the composite outcome of death or neurodevelopmental disability at 18-24 month corrected gestational age.

resultsThis report constitutes a description of outcome for a subgroup of infants enrolled at centers with perinatal follow-up programs. 356 infants were eligible for follow-up from the HeLP trial with a loss to follow-up of 116/356 (32.6%). The primary outcome occurred in 82/113 (72.6%) in the wrap group and 80/127 (63.0%) in the control group (p = 0.115). An unadjusted odds ratio was 1.55 (95% confidence interval = 0.90-2.69) and because of a large loss to follow-up, odds ratios adjusted for potential predictors of the outcome were determined and showed no differences in the primary outcome by group assignment. Secondary outcomes in the wrap versus control group were: cerebral palsy 9/70 (12.9%) versus 5/87 (5.7%) (p = 0.20), Mental Developmental Index < 85 (Bayley Scales) 30/53 (56.6%) versus 33/67 (49.3%) (p = 0.54), blindness at 0/68 (0.0%) versus 1/86 (1.2%) (p > 0.99) and deafness 5/70 (7.1%) versus 6/87 (6.9%) (p > 0.99). No difference was noted in prescription glasses, 7/70 (10.0%) in the wrap group versus 2/87 (2.2%) in the control group (p = 0.09).

conclusionsUse of polyethylene occlusive wrap after birth in very preterm infants was associated with similar death or long-term neurodevelopmental disability rate. TRIALS REGISTION: This trial was registered with Clinicaltrials.gov NCT00607464 on 22 January 2008. Ethics approval was provided by each site and held Mount Sinai Hospital Research Ethics Board (15-0243-C; 7 October 2015).

Indexed as

Developmental DisabilitiesHypothermiaInfant, Premature, DiseasesNeurodevelopmental DisordersFemaleFollow-Up StudiesHumansInfantInfant, NewbornInfant, PrematureMaleBody temperatureChild developmentDelivery roomsHypothermiaInfantNeurodevelopmental disordersPolyethelenePrematureProspective studiesRandom allocation

Identifiers

PMID42638093

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.