NCT03844204

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
440

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 18, 2019

Completed
11 days until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 29, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 29, 2020

Completed
Last Updated

April 3, 2020

Status Verified

April 1, 2020

Enrollment Period

1 year

First QC Date

February 14, 2019

Last Update Submit

April 2, 2020

Conditions

Neonatal Hypothermia

Outcome Measures

Primary Outcomes (1)

  • Proportion of neonates in the normal thermal range (temperature 36.5-37.5°C) at NICU admission

    30 minutes

Secondary Outcomes (9)

  • Proportion of neonates with temperature less than 36.0°C at NICU admission

    30 minutes

  • Proportion of neonates with mild hypothermia (temperature 36.0-36.4°C) at NICU admission

    30 minutes

  • Proportion of hyperthermic neonates (temperature >38.0°C) at NICU admission

    30 minutes

  • Temperature at 1 hour after NICU admission

    1 hour

  • Proportion of ineonates with ntraventricular hemorrhage (grade I-IV)

    7 days

  • +4 more secondary outcomes

Study Arms (2)

Servo-controlled system

EXPERIMENTAL

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

No servo-controlled system

ACTIVE COMPARATOR

The temperature of the infant warmer will be manually set at maximum of power output.

Device: Thermal servo-controlled system

Interventions

Thermal servo-controlled systemDEVICE

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.

No servo-controlled systemServo-controlled system

Eligibility Criteria

Age1 Minute - 1 Minute
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Estimated birth weight \<1500 g and/or gestational age \<30+6 weeks (and)
  • Inborn (and)
  • Parental consent

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Padova

Padua, 35128, Italy

Location

Related Publications (1)

  • 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.

    PMID: 33597230DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Nurses who will measure the temperature at NICU admission are blind to treatment arm in the delivery room
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 14, 2019

First Posted

February 18, 2019

Study Start

March 1, 2019

Primary Completion

February 29, 2020

Study Completion

February 29, 2020

Last Updated

April 3, 2020

Record last verified: 2020-04

Locations

IT(1)