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Effect of a Servo-control System on Heat Loss in Very Low Birth Weight Infants at Birth (SCOPRI)

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ClinicalTrials.gov Identifier: NCT03844204
Recruitment Status : Completed
First Posted : February 18, 2019
Last Update Posted : April 3, 2020
Sponsor:
Information provided by (Responsible Party):
Daniele Trevisanuto, University Hospital Padova

Study Description
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Brief Summary:

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. The thermal servo-controlled systems are routinely used in the NICU to accurately manage the patients' temperature, but their role during the immediate postnatal phase has not been previously assessed.

We hypothesized that using a thermal servo-control system at delivery could prevent heat loss during this delicate phase and increase the percentage of very low birth weight infants (VLBWI) in the normal thermal range (temperature 36.5-37.5°C) at NICU admission. The aim of this study will be to compare two modes of thermal management (with and without the use of a thermal servo-controlled system) for preventing heat loss at birth in VLBWI infants.


Condition or disease Intervention/treatment Phase
Neonatal Hypothermia Device: Thermal servo-controlled system Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 440 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Nurses who will measure the temperature at NICU admission are blind to treatment arm in the delivery room
Primary Purpose: Prevention
Official Title: Effect of a Servo-control System on Heat Loss in Very Low Birth Weight Infants at Birth: a Multicenter, Prospective, Randomized Controlled Trial
Actual Study Start Date : March 1, 2019
Actual Primary Completion Date : February 29, 2020
Actual Study Completion Date : February 29, 2020

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Servo-controlled system
The temperature probe of the servo-controlled system will be positioned on the patient's abdomen with an adhesive tape. The body temperature will be set at 37°C.
 Device: Thermal servo-controlled system
All patients will be positioned under the infant warmer. In the treatment group, a probe positioned on the skin of the neonate will guide the thermal exposure in a servo-controlled modality. In the control group, thermal exposure will be determined manually by setting the power of the heater at the maximum output.
Active Comparator: No servo-controlled system
The temperature of the infant warmer will be manually set at maximum of power output.
 Device: Thermal servo-controlled system
All patients will be positioned under the infant warmer. In the treatment group, a probe positioned on the skin of the neonate will guide the thermal exposure in a servo-controlled modality. In the control group, thermal exposure will be determined manually by setting the power of the heater at the maximum output.


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of neonates in the normal thermal range (temperature 36.5-37.5°C) at NICU admission [ Time Frame: 30 minutes ]

Secondary Outcome Measures :
  1. Proportion of neonates with temperature less than 36.0°C at NICU admission [ Time Frame: 30 minutes ]
  2. Proportion of neonates with mild hypothermia (temperature 36.0-36.4°C) at NICU admission [ Time Frame: 30 minutes ]
  3. Proportion of hyperthermic neonates (temperature >38.0°C) at NICU admission [ Time Frame: 30 minutes ]
  4. Temperature at 1 hour after NICU admission [ Time Frame: 1 hour ]
  5. Proportion of ineonates with ntraventricular hemorrhage (grade I-IV) [ Time Frame: 7 days ]
  6. Propoertions of neoantes with respiratory distress syndrome [ Time Frame: 3 days ]
  7. Proportion of neonates with late onset sepsis [ Time Frame: 14 days ]
  8. Proportion of neonates with bronchopulmonary dysplasia [ Time Frame: 36 gestational weeks ]
  9. Proportion of deaths [ Time Frame: 3 months ]

Eligibility Criteria
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Ages Eligible for Study:   up to 1 Minute   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Estimated birth weight <1500 g and/or gestational age <30+6 weeks (and)
  2. Inborn (and)
  3. Parental consent

Exclusion Criteria:

  1. Major congenital malformations (i.e. cardiac disease, defects of abdominal wall, ...);
  2. Outborn;
  3. Parental refusal to participate to the study.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03844204


Locations
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Italy
University of Padova
Padova, Italy, 35128
Sponsors and Collaborators
University Hospital Padova
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Daniele Trevisanuto, Professor, University Hospital Padova
ClinicalTrials.gov Identifier: NCT03844204    
Other Study ID Numbers: 4371/AO
First Posted: February 18, 2019    Key Record Dates
Last Update Posted: April 3, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypothermia
Birth Weight
Body Temperature Changes
Body Weight