Effect of Drying Before Plastic Wrapping on Thermal Losses in Very Preterm Infants at Birth (NEODRY)

Effect of Drying Before Plastic Wrapping on Thermal Losses in Very Preterm Infants at Birth: a Multicenter, Randomized Controlled Trial

This is a multicenter, unblinded, randomized controlled trial comparing drying vs. not drying before plastic wrapping for the thermoregulation of very preterm infants at birth. The aim of this study will be to compare two modes of thermal management (plastic wrapping with or without drying) for preventing heat loss at birth in very preterm infants.

Study Overview

• Status: Not yet recruiting
• Conditions: Temperature Regulation; Disorder, Fetus or Newborn
• Intervention / Treatment: Other: Drying before wrapping; Other: No drying before wrapping

Detailed Description

Background: Hypothermia in preterm infants during the immediate postnatal phase is associated with morbidity and mortality and remains an unresolved, worldwide challenge.

A list of interventions, including adequate room temperature, use of infant warmers, polyethylene bags/wrap, pre-heated mattresses, caps and heated and humidified gases, to prevent thermal loss at birth in very preterm infants has been recommended, but a certain percentage of very preterm infants are hypothermic at the time of the neonatal intensive care unit (NICU) admission suggesting that further measures are needed. While drying is recommended for the thermal management of infants with gestational age >32 weeks, this procedure is not indicated for very preterm infants who should be put in a plastic wrap immediately at birth without drying. However, such indication is based on studies comparing wrapping without drying vs. drying without wrapping, while the potential advantages of combining these interventions were not explored. We hypothesized that drying before wrapping could prevent heat loss immediately after birth and reduce hypothermia at NICU admission in very preterm infants.

Objective: The aim of this study will be to compare two modes of thermal management (plastic wrapping with or without drying) for preventing heat loss at birth in very preterm infants.

Methods: This is a multicenter, unblinded, randomized controlled trial comparing drying vs. not drying before plastic wrapping for the thermoregulation of very preterm infants at birth. After obtaining parental consent, all infants with estimated birth weight <1500 g and/or gestational age ≤30+6 weeks will be assigned to be managed with or without drying before plastic wrapping. Room temperature and maternal temperature will be measured at the time of delivery. Patients allocated in both groups will be managed based on the current guidelines for neonatal resuscitation. The primary outcome measure will be the proportion of neonates in the normal thermal range (temperature 36.5-37.5°C) at NICU admission. Secondary outcome measures will be: proportion of neonates with hypothermia (<36.5°C and <36.0°C) at NICU admission; proportion of hyperthermic neonates (temperature >37.5°C) at NICU admission; temperature at 1 hour after NICU admission; proportion of intraventricular hemorrhage; proportion of respiratory distress syndrome; proportion of late onset sepsis; proportion of bronchopulmonary dysplasia; mortality before hospital discharge.

• Study Type: Interventional
• Enrollment (Anticipated): 346
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Padova, Italy, 35128
    • Azienda Ospedaliera di Padova, University of Padova

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 6 months (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Estimated birth weight <1500 g and/or gestational age ≤30+6 weeks (and)
• Inborn (and)
• Parental consent; written informed consent will be obtained by a member of the neonatal team involved in the study from a parent or guardian at the maternal admission to the Obstetric Department.

Exclusion Criteria:

• Major congenital malformations (i.e. cardiac disease, defects of abdominal wall, ...);
• Outborn;
• Parental refusal to participate in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Drying before wrapping; Immediately after birth, the infant's body will be dried before wrapping in a plastic bag	Other: Drying before wrapping; Immediately after birth, the infant's body will be dried before wrapping in a plastic bag
Active Comparator: No drying before wrapping; Immediately after birth, the infant will be wrapped in a plastic bag without drying	Other: No drying before wrapping; Immediately after birth, the infant will be put in a plastic bag without wrapping

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number (percentage) of neonates in the normal thermal range (temperature 36.5-37.5°C) at Neonatal Intensive Care Unit admission.	25 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number (percentage) of neonates with hypothermia (temperature <36.5°C) at neonatal intensive care unit admission		25 minutes
Number (percentage) of neonates with moderate-severe hypothermia (temperature <36.0°C) at neonatal intensive care unit admission		25 minutes
Number (percentage) of neonates hyperthermia (temperature >37.5°C) at NICU admission at neonatal intensive care unit admission		25 minutes
Temperature at 1 hour after neonatal intensive care unit admission	Axillary temperature will be registered at 1 hour after neonatal intensive care unit admission	60 minutes
Number (percentage) of infants with intraventricular hemorrhage (all grades and grade III-IV)	The grade of intraventricular hemorrhage will be defined on Levine classification	10 days
Number (percentage) of infants with respiratory distress syndrome	Respiratory distress syndrome will be defined as presence of clinical signs of respiratory distress and radiological findings	72 hours
Number (percentage) of infants with late-onset sepsis	Sespsis will be defined based on the presence of a positive blood colture 72 hours after birth	7 days
Number (percentage) of infants with bronchopulmonary dysplasia	Bronchopulmonary dysplasia will be defined as the need for oxygen at 36 postnatal weeks gestation	36 postnatal weeks
Number (percentage) of infants died before hospital discharge		5 months

Collaborators and Investigators

• Sponsor: University Hospital Padova

Publications and helpful links

General Publications

• Lunze K, Bloom DE, Jamison DT, Hamer DH. The global burden of neonatal hypothermia: systematic review of a major challenge for newborn survival. BMC Med. 2013 Jan 31;11:24. doi: 10.1186/1741-7015-11-24.
• Wyckoff MH, Wyllie J, Aziz K, de Almeida MF, Fabres JW, Fawke J, Guinsburg R, Hosono S, Isayama T, Kapadia VS, Kim HS, Liley HG, McKinlay CJD, Mildenhall L, Perlman JM, Rabi Y, Roehr CC, Schmolzer GM, Szyld E, Trevisanuto D, Velaphi S, Weiner GM; Neonatal Life Support Collaborators. Neonatal Life Support 2020 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science With Treatment Recommendations. Resuscitation. 2020 Nov;156:A156-A187. doi: 10.1016/j.resuscitation.2020.09.015. Epub 2020 Oct 21.
• Madar J, Roehr CC, Ainsworth S, Ersdal H, Morley C, Rudiger M, Skare C, Szczapa T, Te Pas A, Trevisanuto D, Urlesberger B, Wilkinson D, Wyllie JP. European Resuscitation Council Guidelines 2021: Newborn resuscitation and support of transition of infants at birth. Resuscitation. 2021 Apr;161:291-326. doi: 10.1016/j.resuscitation.2021.02.014. Epub 2021 Mar 24.
• Trevisanuto D, Testoni D, de Almeida MFB. Maintaining normothermia: Why and how? Semin Fetal Neonatal Med. 2018 Oct;23(5):333-339. doi: 10.1016/j.siny.2018.03.009. Epub 2018 Mar 21.
• Cavallin F, Doglioni N, Allodi A, Battajon N, Vedovato S, Capasso L, Gitto E, Laforgia N, Paviotti G, Capretti MG, Gizzi C, Villani PE, Biban P, Pratesi S, Lista G, Ciralli F, Soffiati M, Staffler A, Baraldi E, Trevisanuto D; Servo COntrol for PReterm Infants (SCOPRI) Trial Group. Thermal management with and without servo-controlled system in preterm infants immediately after birth: a multicentre, randomised controlled study. Arch Dis Child Fetal Neonatal Ed. 2021 Nov;106(6):572-577. doi: 10.1136/archdischild-2020-320567. Epub 2021 Feb 17.

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2023
• Primary Completion (Anticipated): October 31, 2023
• Study Completion (Anticipated): October 31, 2023

Study Registration Dates

• First Submitted: February 7, 2023
• First Submitted That Met QC Criteria: February 21, 2023
• First Posted (Estimate): February 22, 2023

Study Record Updates

• Last Update Posted (Estimate): February 22, 2023
• Last Update Submitted That Met QC Criteria: February 21, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Temperature; Newborn; Delivery; Prematurity
• Other Study ID Numbers: NEOUNIPD2(2023)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be shared with other researchers upon motivated request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No