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Heat Loss Prevention in Delivery Room Using a Polyethylene Cap

Primary Purpose

Hypothermia, Preterm Infants

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Polyethylene cap
Polyethylene wrap
conventional treatment
Sponsored by
University of Padova
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypothermia, Preterm Infants focused on measuring delivery room, polyethylene cap, preterm infant, temperature

Eligibility Criteria

1 Minute - 3 Minutes (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • infants <29 weeks' gestation born in the study center.

Exclusion Criteria:

  • congenital anomalies with open lesions (e.g. gastroschisis, meningomyelocele) and babies whose delivery was not attended by the neonatal team.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Other

    Arm Label

    cap

    wrap

    conventional group

    Arm Description

    In the cap group, the head of the infant was covered with a polyethylene cap immediately after birth

    Infants in the wrap group were placed into the polyethylene bag, while still wet, up to their necks; only the head was dried.

    Infants in the control group were dried completely, according to International Guidelines for Neonatal Resuscitation.

    Outcomes

    Primary Outcome Measures

    Axillary temperature taken on admission to the NICU (immediately after cap and wrap removal) and again 1 hour later.

    Secondary Outcome Measures

    Mortality prior to hospital discharge, presence of major brain injury, tracheal intubation at birth, Apgar scores, delivery to admission time, blood gas analysis and serum glucose concentration on NICU admission.

    Full Information

    First Posted
    June 30, 2009
    Last Updated
    June 30, 2009
    Sponsor
    University of Padova
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00930917
    Brief Title
    Heat Loss Prevention in Delivery Room Using a Polyethylene Cap
    Official Title
    Heat Loss Prevention in Delivery Room: a Prospective, Randomised, Controlled Trial of Polyethylene Caps in Very Preterm Infants
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2007 (undefined)
    Primary Completion Date
    February 2009 (Actual)
    Study Completion Date
    February 2009 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University of Padova

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    It is apparent that the head of a preterm infant should not be left uncovered, however it remains unclear whether covering the head of a preterm baby with plastic wrapping is effective in preventing heat loss. We conducted a prospective, randomised, controlled trial in very preterm infants to evaluate if a polyethylene cap prevents heat loss after delivery better than polyethylene occlusive wrapping and conventional drying. Furthermore, we assessed body temperature 1 hour after admission to Neonatal Intensive Care Unit (NICU) to evaluate whether the polyethylene cap prevents postnatal heat loss.
    Detailed Description
    The primary outcome measure was axillary temperature taken on admission to the NICU (immediately after cap and wrap removal) and again 1 hour later. Axillary temperature was measured using a digital thermometer (Terumo Digital Clinical Thermometer C202, Terumo Corporation, Tokio, Japan). The occurrence of hypothermia, defined as axillary temperature less then 36.4°C, on NICU admission was also evaluated. Secondary outcomes included mortality prior to hospital discharge, presence of major brain injury (sonographic evidence of intraventricular hemorrhage with ventricular dilatation, parenchymal hemorrhagic infarction, or periventricular leukomalacia), tracheal intubation at birth, Apgar scores, delivery to admission time, blood gas analysis and serum glucose concentration on NICU admission.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypothermia, Preterm Infants
    Keywords
    delivery room, polyethylene cap, preterm infant, temperature

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Factorial Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    96 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    cap
    Arm Type
    Experimental
    Arm Description
    In the cap group, the head of the infant was covered with a polyethylene cap immediately after birth
    Arm Title
    wrap
    Arm Type
    Active Comparator
    Arm Description
    Infants in the wrap group were placed into the polyethylene bag, while still wet, up to their necks; only the head was dried.
    Arm Title
    conventional group
    Arm Type
    Other
    Arm Description
    Infants in the control group were dried completely, according to International Guidelines for Neonatal Resuscitation.
    Intervention Type
    Device
    Intervention Name(s)
    Polyethylene cap
    Intervention Description
    In the cap group, the head of the infant was covered with a polyethylene cap immediately after birth
    Intervention Type
    Device
    Intervention Name(s)
    Polyethylene wrap
    Intervention Description
    Infants in the wrap group were placed into the polyethylene bag, while still wet, up to their necks; only the head was dried.
    Intervention Type
    Other
    Intervention Name(s)
    conventional treatment
    Intervention Description
    Infants in the control group were dried completely, according to International Guidelines for Neonatal Resuscitation.
    Primary Outcome Measure Information:
    Title
    Axillary temperature taken on admission to the NICU (immediately after cap and wrap removal) and again 1 hour later.
    Time Frame
    Admission to the NICU
    Secondary Outcome Measure Information:
    Title
    Mortality prior to hospital discharge, presence of major brain injury, tracheal intubation at birth, Apgar scores, delivery to admission time, blood gas analysis and serum glucose concentration on NICU admission.
    Time Frame
    NICU discharge

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Minute
    Maximum Age & Unit of Time
    3 Minutes
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: infants <29 weeks' gestation born in the study center. Exclusion Criteria: congenital anomalies with open lesions (e.g. gastroschisis, meningomyelocele) and babies whose delivery was not attended by the neonatal team.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Daniele Trevisanuto, MD
    Organizational Affiliation
    Azienda Ospedaliera of Padua
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    20227728
    Citation
    Trevisanuto D, Doglioni N, Cavallin F, Parotto M, Micaglio M, Zanardo V. Heat loss prevention in very preterm infants in delivery rooms: a prospective, randomized, controlled trial of polyethylene caps. J Pediatr. 2010 Jun;156(6):914-917.e1. doi: 10.1016/j.jpeds.2009.12.021. Epub 2010 Mar 15.
    Results Reference
    derived

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    Heat Loss Prevention in Delivery Room Using a Polyethylene Cap

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