Clinical trial NCT05740072: Effect of Drying Before Plastic Wrapping on Thermal Losses in Very Preterm Infants at Birth
Official title: Effect of Drying Before Plastic Wrapping on Thermal Losses in Very Preterm Infants at Birth: a Multicenter, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Temperature Regulation; Disorder, Fetus or Newborn
Keywords: Newborn
Prematurity
Temperature
Delivery
Lead sponsor: University Hospital Padova
Sponsor class: OTHER
First posted: 2023-02-22
Enrollment: 346
Sex: ALL
Minimum age (years): 0
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number (percentage) of neonates in the normal thermal range (temperature 36.5-37.5°C) at Neonatal Intensive Care Unit admission.
timeFrame: 25 minutes
Secondary outcomes:
measure: Number (percentage) of neonates with hypothermia (temperature <36.5°C) at neonatal intensive care unit admission
timeFrame: 25 minutes
measure: Number (percentage) of neonates with moderate-severe hypothermia (temperature <36.0°C) at neonatal intensive care unit admission
timeFrame: 25 minutes
measure: Number (percentage) of neonates hyperthermia (temperature >37.5°C) at NICU admission at neonatal intensive care unit admission
timeFrame: 25 minutes
measure: Temperature at 1 hour after neonatal intensive care unit admission
timeFrame: 60 minutes
measure: Number (percentage) of infants with intraventricular hemorrhage (all grades and grade III-IV)
timeFrame: 10 days
measure: Number (percentage) of infants with respiratory distress syndrome
timeFrame: 72 hours
measure: Number (percentage) of infants with late-onset sepsis
timeFrame: 7 days
measure: Number (percentage) of infants with bronchopulmonary dysplasia
timeFrame: 36 postnatal weeks
measure: Number (percentage) of infants died before hospital discharge
timeFrame: 5 months
Other outcomes:
Locations:
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova, University of Padova
Study officials:
References:
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citation: 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.
citation: 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.
citation: 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.