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Cardboard Cot: Prevention of Moderate or Severe Hypothermia in Preterm Infants Assigned to Open Crib

Primary Purpose

Infant, Premature

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cardboard Cot Care
Open Crib
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Infant, Premature focused on measuring Hypothermia, Newborn

Eligibility Criteria

24 Hours - 2 Weeks (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Estimated gestational age < 36 6/7 weeks
  • Hospitalized in the newborn ICU at University Teaching Hospital
  • Nursed in an incubator for at least 24 hours
  • Thought to be ready to be weaned from incubator by the clinical staff

Exclusion Criteria:

  • Major congenital anomalies
  • Requiring ongoing respiratory support
  • Suspected sepsis

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Cardboard Cot Care

    Open Crib

    Arm Description

    Stable infant will be transferred to cardboard cot, lined with reflective film for duration of hospital stay following weaning from radiant warmer. Infant's axillary temperature will be taken at 1 hour, 6 hours, 24 hours after being placed in the cot or crib, and then once every 24 hours until discharge.

    Stable infant will be transferred to standard of care open crib for duration of hospital stay following weaning from radiant warmer. Infant's axillary temperature will be taken at 1 hour, 6 hours, 24 hours after being placed in the cot or crib, and then once every 24 hours until discharge.

    Outcomes

    Primary Outcome Measures

    Moderate (32.0-35.9° C) or Severe (<32.0° C) Hypothermia at discharge per axillary Temperature

    Secondary Outcome Measures

    Hypothermia (< 36.0° C) throughout the duration of the intervention measured by axillary temperature
    Mean Axillary Temperatures on All Infants Weaned to Cardboard Cots
    Mean Axillary Temperatures on All Infants Weaned to Open Cribs
    Moderate Hypothermia (32.0-35.9° C) after placement in warming device measured by axillary Temperature
    Moderate Hypothermia (32.0-35.9° C) after placement in warming device measured by axillary temperature
    Moderate Hypothermia (32.0-35.9° C) after placement in warming device measured by axillary temperature
    Severe (<32.0° C) Hypothermia after placement in the warming device measured by axillary temperature
    Severe (<32.0° C) Hypothermia after placement in the warming device measured by axillary temperature
    Severe (<32.0° C) Hypothermia after placement in the warming device measured by axillary temperature
    Rate of Hyperthemia (>38° C) measured by axillary temperature
    Rate of Normothermia (>36.5° C) at discharge measured by axillary temperature

    Full Information

    First Posted
    November 14, 2017
    Last Updated
    October 22, 2021
    Sponsor
    University of Alabama at Birmingham
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03344991
    Brief Title
    Cardboard Cot: Prevention of Moderate or Severe Hypothermia in Preterm Infants Assigned to Open Crib
    Official Title
    Cardboard Cot in Neonatal Thermoregulation: Prevention of Moderate or Severe Hypothermia in Preterm Infants Assigned to Open Crib
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Unable to recruit participants
    Study Start Date
    June 11, 2019 (Actual)
    Primary Completion Date
    September 27, 2021 (Actual)
    Study Completion Date
    September 27, 2021 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Alabama at Birmingham

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Infants with an estimated gestational age < 36 6/7 weeks at delivery who have been in an incubator in the newborn ICU for at least 24 hours in settings where an incubator is available, or who are delivered in a setting where an incubator is not available, will be randomized to either standard protocol of open crib or mylar-lined cardboard cot for the duration of the hospital stay. Axillary temperatures will be taken 1 hr, 6 hrs, and 24 hours after being placed in the cot or crib, and then once every 24 hours. All other care is provided as standard of care.
    Detailed Description
    Following parental consent, preterm infants with an estimated gestational age < 36 6/7 weeks at delivery who have been in an incubator in the newborn ICU for at least 24 hours in settings where an incubator is available, or who are in the newborn ICU in a setting where an incubator is not available, will be randomized to to transfer either standard protocol of open crib or mylar-lined cardboard cot when their temperatures are stable for transfer. The infants will remain in the cot or crib for the duration of the hospital stay. Axillary temperatures will be taken 1 hr, 6 hrs, and 24 hours after being placed in the cot or crib, and then once every 24 hours. All other care is provided as standard of care, including WHO warm chain thermoregulation guidelines of early and exclusive breastfeeding, appropriate bundling and Kangaroo Mother Care as continuously as possible. If at any point a babies becomes moderately (32.0-35.9° C) or severely hypothermic (< 32.0° C), an extra blanket will be added to their bodies and a hat placed on their heads.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Infant, Premature
    Keywords
    Hypothermia, Newborn

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Infants will be randomized to either open crib (standard of care) or mylar-lined cardboard box following care in a radiant warmer
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Cardboard Cot Care
    Arm Type
    Active Comparator
    Arm Description
    Stable infant will be transferred to cardboard cot, lined with reflective film for duration of hospital stay following weaning from radiant warmer. Infant's axillary temperature will be taken at 1 hour, 6 hours, 24 hours after being placed in the cot or crib, and then once every 24 hours until discharge.
    Arm Title
    Open Crib
    Arm Type
    Placebo Comparator
    Arm Description
    Stable infant will be transferred to standard of care open crib for duration of hospital stay following weaning from radiant warmer. Infant's axillary temperature will be taken at 1 hour, 6 hours, 24 hours after being placed in the cot or crib, and then once every 24 hours until discharge.
    Intervention Type
    Other
    Intervention Name(s)
    Cardboard Cot Care
    Intervention Description
    When ready to be weaned from radiant warmer, infant will be placed in a reflective film-lined cot for the duration of hospitalization. Axillary temperatures will be taken at 1 hour, 6 hours, and 24 hours after placement in cot, and every 24 hours thereafter until discharge. If temperatures found < 36.0 at any time, an additional blanket and hat will be added to infant to improve temperature. All other care will be standard of care at University Teaching Hospital, including early and exclusive breastfeeding, appropriate bundling, and Kangaroo Mother Care as continuously as possible.
    Intervention Type
    Other
    Intervention Name(s)
    Open Crib
    Intervention Description
    When ready to be weaned from radiant warmer, infant will be placed in a standard of care open crib for the duration of hospitalization. Axillary temperatures will be taken at 1 hour, 6 hours, and 24 hours after placement in cot, and every 24 hours thereafter until discharge. If temperatures found < 36.0 at any time, an additional blanket and hat will be added to infant to improve temperature. All other care will be standard of care at University Teaching Hospital, including early and exclusive breastfeeding, appropriate bundling, and Kangaroo Mother Care as continuously as possible.
    Primary Outcome Measure Information:
    Title
    Moderate (32.0-35.9° C) or Severe (<32.0° C) Hypothermia at discharge per axillary Temperature
    Time Frame
    Up to 14 days
    Secondary Outcome Measure Information:
    Title
    Hypothermia (< 36.0° C) throughout the duration of the intervention measured by axillary temperature
    Time Frame
    Up to14 days
    Title
    Mean Axillary Temperatures on All Infants Weaned to Cardboard Cots
    Time Frame
    4 months
    Title
    Mean Axillary Temperatures on All Infants Weaned to Open Cribs
    Time Frame
    4 months
    Title
    Moderate Hypothermia (32.0-35.9° C) after placement in warming device measured by axillary Temperature
    Time Frame
    1 hour after placement in warming device
    Title
    Moderate Hypothermia (32.0-35.9° C) after placement in warming device measured by axillary temperature
    Time Frame
    6 hours
    Title
    Moderate Hypothermia (32.0-35.9° C) after placement in warming device measured by axillary temperature
    Time Frame
    24 hours after placement in warming device
    Title
    Severe (<32.0° C) Hypothermia after placement in the warming device measured by axillary temperature
    Time Frame
    1 hour after placement in warming device
    Title
    Severe (<32.0° C) Hypothermia after placement in the warming device measured by axillary temperature
    Time Frame
    6 hours after placement in warming device
    Title
    Severe (<32.0° C) Hypothermia after placement in the warming device measured by axillary temperature
    Time Frame
    24 hours after placement in warming device
    Title
    Rate of Hyperthemia (>38° C) measured by axillary temperature
    Time Frame
    14 days
    Title
    Rate of Normothermia (>36.5° C) at discharge measured by axillary temperature
    Time Frame
    Up to 14 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    24 Hours
    Maximum Age & Unit of Time
    2 Weeks
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Estimated gestational age < 36 6/7 weeks Hospitalized in the newborn ICU at University Teaching Hospital Nursed in an incubator for at least 24 hours Thought to be ready to be weaned from incubator by the clinical staff Exclusion Criteria: Major congenital anomalies Requiring ongoing respiratory support Suspected sepsis
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Colm P Travers, MB BCh BAO
    Organizational Affiliation
    University of Alabama at Birmingham
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Cardboard Cot: Prevention of Moderate or Severe Hypothermia in Preterm Infants Assigned to Open Crib

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