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Brochure_Neohelp_2025

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NEONATOLOGY

HEAT LOSS PREVENTION SUIT

neohelpTM


NEONATAL HYPOTHERMIA: A WORLDWIDE ISSUE

neohelp

Hypothermia is an important factor in morbidity and mortality of all birth weights and gestational ages, and particularly for vulnerable preterm infants1

« The incidence of hypothermia is between 31% and 78% for those with birth weight less than 1500 g » 2

Stages of body temperature fluctuation1

Hypothermia

« Immediately after birth, neonates can lose heat [...] that can cause a reduction of up to 2°C of their body temperature within the first 10–20 min of birth » 3

« Infants at less than 28 weeks’ gestation have the highest incidence of hypothermia » 2

Consequences of hypothermia

Normothermia Hyperthermia

< 32°C

32-36°C

36-36.5°C

Severe hypothermia

Moderate hypothermia

Potential cold stress

36.5-37.5°C

Death

> 37.5°C

Intraventricular hemorrhage Respiratory distress

Four main factors of heat loss

Hypoglycemia

Evaporation From the humidified skin

Radiation Large areas of skin exposed to cooler surroundings

Brain damage

Hypoxia

Convection Cold air flows

Infection / Septicaemia

Coagulation defects

Metabolic acidosis

1

Each

Risk of sepsis +11%

in body temperature

Risk of death +28%

-1°C Conduction Contact with cold surfaces


neohelpTM, POLYETHYLENE OCCLUSIVE SUIT TO PREVENT HEAT LOSS

4

neohelp

neohelpTM is a sterile suit to swaddle the infant immediately after delivery (before resuscitation).

International recommendations

Interventions to prevent hypothermia at birth in preterm and/or low birth weight infants Use of an occlusive polyethylene transparent wrap or bag immediately at birth improved admission temperatures in nonrandomised studies of infants at < 27 weeks’ gestation […], between 28 and 30, weeks […] and at < 33 weeks’ gestation […], as well as in very low birth weight infants and extremely 5 low birth weight infants when compared with routine care

Technical features Adjustable hood • Limits heat loss by radiation, convection and evaporation • Adjustable to the infant’s head

Double layer of Polyethylene • • •

Limits heat loss by convection and evaporation Allows good skin contact due to the thin inner layer Allows passage of radiant heat from the warmer6

Cochrane Database of Systematic Reviews - 2018

Pre-shaped foam cushion

Improvement in thermoregulation outcomes following the implementation of a thermoregulation bundle for preterm infants The key practice changes included: improved anticipation and staff preparedness, wrapping infant in a polyethylene sheet, using a polyethylene lined bonnet, using servo-control 1 mode at birth and during transport. Journal of Pediatrics and Child Health - 2022

According to UNICEF, such interventions can help reduce neonatal mortality or morbidity by 18-42 %8

• Limits heat loss by conduction • Helps to maintain an open airway (by raising the shoulders level)7 • Stabilises the infant’s position • Facilitates carrying of the infant • Provides comfort to the infant

Adapted materials •

•

Transparent and silent material that enables the visualization of the skin color and the infant’s breathing movement Non-toxic and biocompatible material (ISO 10993-1)

Central opening • Velcro® closure that ensures heat conservation • Easy and quick placement of the infant • Easy access to the infant’s body • Designed for easy placement of monitoring equipment, IV and umbilical catheters


CLINICAL STUDY: neohelpTM VS NON-STERILE PLASTIC BAG

9

neohelp

Evaluation of two polyethylene bags in preventing admission hypothermia in preterm infants : a quasi-randomized clinical trial; A. L. C. Possidente et al. Jornal de Pediatria - 2023

Objective

Results

This study aims to evaluate two polyethylene bags in preventing admission hypothermia (AH) in preterm infants, at a level III neonatal unit of the Women’s Hospital of the State University of Campinas in Brazil.

Frequency of admission hypothermia in each group

Study design 15%

171 preterm infants Between 24 and 33 GA Between 500 and 3000 g

14.7%

10%

2.6%

5%

95 preterm infants

76 preterm infants

Use of a non-sterile plastic bag

Use of neohelp

Non-sterile plastic bag

TM

neohelpTM

Observations regarding preterm infants using neohelp™ have shown: • significantly less frequent admission hypothermia • 86% risk reduction of the condition

Primary outcome: Admission hypothermia (axillary temperature at admission to the neonatal unit of <36.0 °C)

Conclusion Based on these results, the suggested benefits are the following

• n eohelp™ is more effective in reducing admission hypothermia in infants born at < 34 weeks

General warning: Preterm infants have reduced disabilities to dissipate heat, that is why hyperthermia is an important issue to be considered carefully. The regular monitoring of the newborn’s temperature is essential.


INDICATIONS FOR USE

neohelp

neohelpTM is the solution to prevent hypothermia in the following situations:

Delivery room

NICU

Transport From delivery room to NICU

Cesarean Delayed cord clamping (DCC) Resuscitation

From hospital to hospital

PICC placement

Scan the QR code

Umbilical catheter placement

Scan the QR code

Scan the QR code

Unplanned delivery Scan the QR code

Protocol for DCC in premature infants < 34 weeks successfully utilized polyethylene wraps […] to prevent hypothermia in both vaginal as well as 10 cesarean deliveries

The plastic drape reduced the hypothermia rate in the NICU for VLBW neonates during PICC placement 11 compared with cloth blanket/towels

Each QR will lead you to a more detailed document regarding each of the indications for use.

The transport incubator used to limit heat loss can be cumbersome and difficult to obtain. It may be « replaced » by […] a transparent polyethylene bag wrapping whilst the baby is still wet. This greatly 12 reduces the risk of hypothermia


HOW TO USE neohelpTM

neohelp

37°

1) Unfold neohelp™ completely. 2) P lace it on the resuscitation table, under the heat lamp (if applicable). 3) F ully open the Velcro® and the hood to facilitate the infant’s reception.

4) Do not dry the baby at birth. 5) Place the baby immediately after birth in neohelp™. 6) Align the shoulders at the upper edges of the foam. 7) Easily close the Velcro® tightly along its entire length.

8) Adjust the hood to the head of the infant. Do not cover the airways due to the risk of suffocation. 9) Other heating appliances will need to be adjusted accordingly due to risk of hyperthermia.

10) The infant should be kept wrapped until temperature stabilization. 11) Temperature of the infant should be monitored continuously or consecutively (ideally every 5 minutes). 12) Do not use more than 24 hours.

Technical features

Designation

Dimensions

Code

Quantity

neohelpTM SMALL < 1KG

L. 38 x W. 30 cm

37.09.14

10/box

neohelpTM MEDIUM 1KG - 2.5KG

L. 44 x W. 38 cm

37.09.15

10/box

neohelpTM LARGE > 2.5KG

L. 50 x W. 38 cm

37.09.16

10/box

13) neohelp™ is suitable with the use of an hemostatic device to eliminate bleeding from the cord vessels. 14) If a medical device such as an umbilical catheter is needed, simply open the Velcro®, insert the device, and once again easily close the Velcro® along its entire length.


References 1. S ingh TS, Skelton H, Baird J, Padernia AM, Maheshwari R, Shah DM, D’Cruz D, Luig M, Jani P. Improvement in thermoregulation outcomes following the implementation of a thermoregulation bundle for preterm infants. J Paediatr Child Health. 2022 Jul;58(7):1201-1208. doi: 10.1111/jpc.15949. Epub 2022 Mar 30. PMID: 35353411; PMCID: PMC9310766. 2. M anani M, Jegatheesan P, DeSandre G, Song D, Showalter L, Govindaswami B. Elimination of admission hypothermia in preterm very low-birth-weight infants by standardization of delivery room management. Perm J. 2013 Summer;17(3):8-13. doi: 10.7812/TPP/12-130. PMID: 24355884; PMCID: PMC3783084. 3. Alebachew Bayih W, Assefa N, Dheresa M, Minuye B, Demis S. Neonatal hypothermia and associated factors within six hours of delivery in eastern part of Ethiopia: a crosssectional study. BMC Pediatr. 2019 Jul 24;19(1):252. doi: 10.1186/s12887-019-1632-2. PMID: 31340772; PMCID: PMC6651976. 4. Vohra S, Roberts RS, Zhang B, Janes M, Schmidt B. Heat Loss Prevention (HeLP) in the delivery room: A randomized controlled trial of polyethylene occlusive skin wrapping in very preterm infants. J Pediatr. 2004 Dec;145(6):750-3. doi: 10.1016/j.jpeds.2004.07.036. PMID: 15580195. 5. M cCall EM, Alderdice F, Halliday HL,Vohra S, Johnston L. Interventions to prevent hypothermia at birth in preterm and/or low birth weight infants. Cochrane Database Syst Rev. 2018 Feb 12;2(2):CD004210. doi: 10.1002/14651858.CD004210.pub5. PMID: 29431872; PMCID: PMC6491068. 6. Thalia Cordaro, Ann Gibbons Phalen, Ksenia Zukowsky. Hypothermia and Occlusive skin wrap in the low birth weight premature infant: an evidentiary review. NAINR. 2012;12(2):78-85 7. Australian and New Zealand Committee on Resuscitation. (2021). ANZCOR Guideline 13.4 Airway Management and Mask Ventilation of the Newborn- April 2021. Retrieved from https://www.resus.org.nz/assets/Uploads/ANZCOR-Guideline-13.4-April-2021.pdf 8. Wariki WMV and Mori R. Interventions to prevent hypothermia at birth in preterm and/or low-birth-weight infants: RHL commentary (last revised: 1 June 2010). The WHO Reproductive Health Library; Geneva: World Health Organization.

10. C hantry CJ, Blanton A, Taché V, Finta L, Tancredi D. Delayed cord clamping during elective cesarean deliveries: results of a pilot safety trial. Matern Health Neonatol Perinatol. 2018 Jul 4;4:16. doi: 10.1186/s40748-018-0083-3. PMID: 29997897; PMCID: PMC6031144. 11. P han HKT, McIntyre TM. Using a Plastic Drape to Reduce Hypothermia in Premature Neonates During Peripherally Inserted Central Catheter Placement. Adv Neonatal Care. 2022 Jun 1;22(3):193-202. doi: 10.1097/ANC.0000000000000906. Epub 2021 Jun 16. PMID: 34138792. 12. J.F. Diependaele, A. Fily. Management of a newborn baby – 51st congress of French Society of Anesthesia and Intensive Care - 2009

FOR FURTHER INFORMATION, PLEASE CONTACT: questions@vygon.com

The specification shown in this leaflet are for information only and are not, under any circumstances, of a contractual nature. VYGON – 5, RUE ADELINE - 95440 ECOUEN - FRANCE RECEPTION: +33 (0)1 39 92 63 63 – SERVICE CLIENTS FRANCE: +33 (0)1 39 92 63 81 EXPORT CUSTOMER SERVICE: +33 (0)1 39 92 64 15

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12/2024 - DB NEON 14 255 E

9. P ossidente ALC, Bazan IGM, Machado HC, Marba STM, Caldas JPS. Evaluation of two polyethylene bags in preventing admission hypothermia in preterm infants: a quasirandomized clinical trial. J Pediatr (Rio J). 2023 Sep-Oct;99(5):514-520. doi: 10.1016/j.jped.2023.04.004. Epub 2023 May 10. PMID: 37172616; PMCID: PMC10492142.


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