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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Temperature Regulation; Disorder, Fetus or Newborn

Intervention / Treatment
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* Other: Drying before wrapping
* Other: No drying before wrapping


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 0 Minutes
Maximum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Newborn, Prematurity, Temperature, Delivery