Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2023 Sep-Oct;99(5):514-520.
doi: 10.1016/j.jped.2023.04.004. Epub 2023 May 10.

Evaluation of two polyethylene bags in preventing admission hypothermia in preterm infants: a quasi-randomized clinical trial

Ana L C Possidente  1 , Ivan G M Bazan  1 , Helymar C Machado  2 , Sergio T M Marba  3 , Jamil P S Caldas  4
Affiliations
Randomized Controlled Trial

Evaluation of two polyethylene bags in preventing admission hypothermia in preterm infants: a quasi-randomized clinical trial

Ana L C Possidente et al. J Pediatr (Rio J). 2023 Sep-Oct.

Abstract

Objective: To compare two polyethylene bags in preventing admission hypothermia in preterm infants born at <34 weeks gestation.

Method: Quasi-randomized unblinded clinical trial conducted at a level III neonatal unit between June 2018 to September 2019. The authors assign infants between 240/7 and 336/7 weeks' gestation to receive NeoHelp™ bag (intervention group) or a usual plastic bag (control group). The primary outcome was admission hypothermia, considering an axillary temperature at admission to the neonatal unit of <36.0 °C. Hyperthermia was considered if the admission temperature reached 37.5 °C or more.

Results: The authors evaluated 171 preterm infants (76, intervention group; 95, control group). The rate of admission hypothermia was significantly lower in the intervention group (2.6% vs. 14.7%, p = 0.007), with an 86% reduction in the admission hypothermia rate (OR, 0.14; 95% CI, 0.03-0.64), particularly for infants weighing >1000 g and >28 weeks gestation. The intervention group also had a higher median of temperature at admission - 36.8 °C (interquartile range 36.5-37.1) vs. 36.5 °C (interquartile range 36.1-36.9 °C), p = 0.001, and showed a higher hyperthermia rate (9.2% vs. 1.0%, p = 0.023). Birth weight was also associated to the outcome, and it represented a 30% chance reduction for every 100-g increase (OR, 0.997; 95% CI, 0.996-0.999). The in-hospital mortality rate was similar between groups.

Conclusion: The intervention polyethylene bag was more effective in preventing admission hypothermia. Nonetheless, the risk of hyperthermia is a concern during its use.

Keywords: Clinical trial; Delivery room; Hyperthermia; Hypothermia; Infant, premature.

PubMed Disclaimer

Conflict of interest statement

Conflicts of interest The authors declare no conflicts of interest relevant to this article. Vygon® (Neohelp™ manufacturer) did not fund this study and was not involved in any aspect of this project (material donation, trial design, data analysis, writing of the results, or approval of the final manuscript). The authors declare that the Neohelp™ bags were acquired by a fund granted by the Fund for Support to Teaching, Research and Outreach Activities – FAEPEX of the State University of Campinas.

Figures

Fig 1
Figure 1
Intervention and control plastic bag.
Fig 2
Figure 2
Flow diagram.
See this image and copyright information in PMC

References

    1. Lyu Y., Shah P.S., Ye X.Y., Warre R., Piedboeuf B., Deshpandey A., et al. Association between admission temperature and mortality and major morbidity in preterm infants born at fewer than 33 weeks’ gestation. JAMA Pediatr. 2015;169:150–277. - PubMed
    1. Wilson E., Maier R.F., Norman M., Misselwitz B., Howell E.A., Zeitlin J., et al. Admission hypothermia in very preterm infants and neonatal mortality and morbidity. J Pediatr. 2016;175:61–67. - PubMed
    1. Laptook A.R., Bell E.F., Shankaran S., Boghossian N.S., Wyckoff M.H., Kandefer S., et al. Admission temperature and associated mortality and morbidity among moderately and extremely preterm infants. J Pediatr. 2018;192:53–59. e2. - PMC - PubMed
    1. McCall E.M., Alderdice F., Halliday H.L., Vohra S., Johnston L. Interventions to prevent hypothermia at birth in preterm and/or low birth weight infants. Cochrane Database Syst Rev. 2018;12 - PMC - PubMed
    1. American Academy of Pediatrics . Textbook of neonatal resuscitation. 7th ed. American Academy of Pediatrics; Elk Grove Village, IL: 2016. Resuscitation and stabilization of babies born preterm. Weiner GM.

Publication types

LinkOut - more resources