NCT00312065

Brief Summary

The purpose of this study is to examine the need for reflective heat shield covers over the temperature probes applied to the skin of newborn babies who are being nursed under a radiant warmer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2003

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

Study Start

First participant enrolled

October 1, 2003

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

April 5, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 7, 2006

Completed
Last Updated

April 7, 2015

Status Verified

April 1, 2015

Enrollment Period

1.5 years

First QC Date

April 5, 2006

Last Update Submit

April 6, 2015

Conditions

Impaired Thermoregulation

Keywords

servocontrolledradiant warmerthermistorheat shield

Outcome Measures

Primary Outcomes (1)

  • The effect of the use of the reflective heat shield on the measured skin temperature of the baby

Secondary Outcomes (2)

  • The effect of the use of the reflective heat shield on the measured rectal temperature of the baby

  • The effect of the use of the reflective heat shield on the measured power output of the radiant warmer

Study Arms (1)

Patient

EXPERIMENTAL

Once stabilized, a trimmed reflective shield to cover only the probe itself will be placed over the thermistor probe. Changes in measured skin temperature and warmer power output will be recorded non-invasively, as well as the time taken to reestablish baseline status. A full-sized reflective shield will then be placed over the thermistor probe and the same observations recorded, then repeated 15 minutes later. At the time of a subsequent routine change in thermistor position, the same procedure will be followed, but omitting the intermediate step of using the smaller trimmed shield. Continuous core temperatures will be monitored via a short rectal probe during the study periods.

Device: Application of reflective heat shield to thermistor probe

Interventions

Application of reflective heat shield to thermistor probeDEVICE
Patient

Eligibility Criteria

AgeUp to 1 Week
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Stable newborn infants greater than 1000g birth weight
  • On room air or on CPAP in 21% oxygen
  • Being nursed under radiant warmer

You may not qualify if:

  • Major congenital anomalies
  • Significant dermatological pathology or abnormalities
  • Documented or suspected sepsis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

Study Officials

  • Alan M de Klerk, MBChB

    Maimonides Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Director of Neonatology

Study Record Dates

First Submitted

April 5, 2006

First Posted

April 7, 2006

Study Start

October 1, 2003

Primary Completion

April 1, 2005

Study Completion

April 1, 2005

Last Updated

April 7, 2015

Record last verified: 2015-04

Locations

US(1)