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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

Tracking Information
First Submitted Date  ICMJE February 14, 2019
First Posted Date  ICMJE February 18, 2019
Last Update Posted Date April 3, 2020
Actual Study Start Date  ICMJE March 1, 2019
Actual Primary Completion Date February 29, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 14, 2019)
Proportion of neonates in the normal thermal range (temperature 36.5-37.5°C) at NICU admission [ Time Frame: 30 minutes ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 14, 2019)
  • Proportion of neonates with temperature less than 36.0°C at NICU admission [ Time Frame: 30 minutes ]
  • Proportion of neonates with mild hypothermia (temperature 36.0-36.4°C) at NICU admission [ Time Frame: 30 minutes ]
  • Proportion of hyperthermic neonates (temperature >38.0°C) at NICU admission [ Time Frame: 30 minutes ]
  • Temperature at 1 hour after NICU admission [ Time Frame: 1 hour ]
  • Proportion of ineonates with ntraventricular hemorrhage (grade I-IV) [ Time Frame: 7 days ]
  • Propoertions of neoantes with respiratory distress syndrome [ Time Frame: 3 days ]
  • Proportion of neonates with late onset sepsis [ Time Frame: 14 days ]
  • Proportion of neonates with bronchopulmonary dysplasia [ Time Frame: 36 gestational weeks ]
  • Proportion of deaths [ Time Frame: 3 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of a Servo-control System on Heat Loss in Very Low Birth Weight Infants at Birth
Official Title  ICMJE Effect of a Servo-control System on Heat Loss in Very Low Birth Weight Infants at Birth: a Multicenter, Prospective, Randomized Controlled Trial
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Neonatal Hypothermia
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Device: Thermal servo-controlled system
  • Active Comparator: No servo-controlled system
    The temperature of the infant warmer will be manually set at maximum of power output.
    Intervention: Device: Thermal servo-controlled system
Publications * 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 Feb 17. pii: fetalneonatal-2020-320567. doi: 10.1136/archdischild-2020-320567. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 14, 2019)
440
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 29, 2020
Actual Primary Completion Date February 29, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 1 Minute   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03844204
Other Study ID Numbers  ICMJE 4371/AO
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Daniele Trevisanuto, University Hospital Padova
Study Sponsor  ICMJE University Hospital Padova
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University Hospital Padova
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP