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Umbilical or Peripheral Catheter Insertion for Preterm Infants on Admission to the NICU (UP)

Primary Purpose

Hypothermia, Newborn, Preterm Birth Complication, Neonatal Hypothermia

Status
Unknown status
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
Vascular access on admission
Sponsored by
University College Dublin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypothermia, Newborn

Eligibility Criteria

1 Minute - 60 Minutes (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • inborn infants admitted to the NICU with;
  • gestational age < 29 weeks (up to 28+6 weeks) OR
  • birth weight < 1250g.

Exclusion Criteria:

  • end of life (palliative) care
  • large abdominal wall defects
  • imperforate anus.

Sites / Locations

  • National Maternity HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

Insertion of peripheral venous catheter on admission to the NICU

Insertion of and umbilical venous catheter on admission

Outcomes

Primary Outcome Measures

Core (rectal) temperature 2 hours after birth
Core (rectal) temperature 2 hours after birth

Secondary Outcome Measures

Axillary temperature at the end of the procedure
Mean difference in axillary temperature from admission to end of procedure
Time to completion of procedure (incubator roof down, portholes closed and hands off)
Time to first intravenous infusion starting (PN / dextrose / antibiotics / caffeine)
Number (%) infants that have umbilical catheters inserted during their admission
Number (%) lines used without repositioning
Number (%) lines repositioned
Number (%) of low lying umbilical venous catheters
Number (%) of infants' in whom attempted placement of an umbilical line was not successful
Definition: an attempt made to insert a central catheter that is not used at any point during the infant's admission (i.e. nothing was infused through the line)
Number of peripheral line attempts
Number (%) of infants in whom PIVC as first point of access was unsuccessful (nothing was infused through the line)
Complications of line insertion/placement
Blood stream infections (CRBSI)
Number of x-rays performed in first 24 hours
Blood sampling in first 24 hours
Number of blood tests in 72 hours
Number of blood transfusions during hospital stay
Peripheral arterial line insertion in the first 7 days of life
PICC line insertion in the first 7 days of life
Inotropes administered in the first 72 hours of life
Intubation + Ventilation
Surfactant administration
Necrotizing enterocolitis (Bell's staging)
Intraventricular Haemorrhage (Papile classification)
Periventricular leukomalacia
Chronic lung disease
In hospital mortality

Full Information

First Posted
February 9, 2021
Last Updated
April 27, 2021
Sponsor
University College Dublin
Collaborators
Irish Research Council
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1. Study Identification

Unique Protocol Identification Number
NCT04761484
Brief Title
Umbilical or Peripheral Catheter Insertion for Preterm Infants on Admission to the NICU
Acronym
UP
Official Title
A Randomised Trial of Umbilical or Peripheral Catheter Insertion for Preterm Infants on NICU Admission
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
July 2022 (Anticipated)
Study Completion Date
October 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University College Dublin
Collaborators
Irish Research Council

4. Oversight

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

5. Study Description

Brief Summary
Preterm infants are at risk of hypothermia following delivery and in the first few hours of life. Hypothermia in extremely low birth weight infants' is an independent risk factor for death. These infants' are at additional risk of hypothermia when they undergo procedures such as central catheter insertion following admission. The investigators think that in extremely preterm infants, placing a peripheral intravenous cannula on admission to the NICU, instead of umbilical catheters (UVC and/or UAC), will increase the proportion of infants with a rectal temperature in the normal range at 2 hours of life.
Detailed Description
Hypothermia is an independent risk factor for death in preterm newborns.(1) Despite measures to improve temperature in preterm newborns in the delivery room (DR), hypothermia on admission to the neonatal intensive care unit (NICU) at NMH is common. In a cohort of infants < 32 weeks' gestation born at NMH in 2019, 54% of infants had a rectal temperature < 36.5 oC on admission to the NICU.(2) Many preterm infants have procedures performed soon after admission to the NICU; in 2019, 98% of infants born before 29 weeks' gestation at NMH had an umbilical venous catheter inserted. This may/often involve(s) prolonged periods of handling and potential exposure to cold. The investigators prospectively studied a cohort of 26 infants < 32 weeks who had invasive procedures within 3 hours of birth performed in the NICU at NMH between November 2018 and June 2019. Almost three-quarters [19/26 (73%)] had an abnormal temperature at the beginning of the procedure; and 17/26 (65%) had an abnormal temperature at the end of the procedure. Only 3 (11%) infants maintained a normal temperature throughout the procedure. Perhaps more concerning is the severity of the hypothermia observed; 13 (50%) infants had a temperature < 36.0oC before and 11 (42%) after the procedure. The median duration of procedure was 53 (37, 73) minutes.(3) The investigators think that in extremely preterm infants, placing a peripheral intravenous cannula on admission to the NICU, instead of umbilical catheters (UVC and/or UAC), will increase the proportion of infants with a rectal temperature in the normal range at 2 hours of life.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypothermia, Newborn, Preterm Birth Complication, Neonatal Hypothermia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomly assigned in blocks of 4 in a 1:1 ratio, stratified by GA (23 - 25+6, 26 - 28+6) and by admission temperature (normal temperature [36.5oC- 37.5oC] , abnormal temperature [<36.5oC or >37.5oC]).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
116 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Insertion of peripheral venous catheter on admission to the NICU
Arm Title
Control
Arm Type
No Intervention
Arm Description
Insertion of and umbilical venous catheter on admission
Intervention Type
Procedure
Intervention Name(s)
Vascular access on admission
Intervention Description
PIVC insertion
Primary Outcome Measure Information:
Title
Core (rectal) temperature 2 hours after birth
Description
Core (rectal) temperature 2 hours after birth
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Axillary temperature at the end of the procedure
Time Frame
up to 24 hours
Title
Mean difference in axillary temperature from admission to end of procedure
Time Frame
up to 24 hours
Title
Time to completion of procedure (incubator roof down, portholes closed and hands off)
Time Frame
up to 24 hours
Title
Time to first intravenous infusion starting (PN / dextrose / antibiotics / caffeine)
Time Frame
up to 24 hours
Title
Number (%) infants that have umbilical catheters inserted during their admission
Time Frame
up to 24 hours
Title
Number (%) lines used without repositioning
Time Frame
up to 24 hours
Title
Number (%) lines repositioned
Time Frame
up to 24 hours
Title
Number (%) of low lying umbilical venous catheters
Time Frame
up to 24 hours
Title
Number (%) of infants' in whom attempted placement of an umbilical line was not successful
Description
Definition: an attempt made to insert a central catheter that is not used at any point during the infant's admission (i.e. nothing was infused through the line)
Time Frame
up to 24 hours
Title
Number of peripheral line attempts
Time Frame
up to 24 hours
Title
Number (%) of infants in whom PIVC as first point of access was unsuccessful (nothing was infused through the line)
Time Frame
24 hours
Title
Complications of line insertion/placement
Time Frame
10 days
Title
Blood stream infections (CRBSI)
Time Frame
up to 16 weeks
Title
Number of x-rays performed in first 24 hours
Time Frame
24 hours
Title
Blood sampling in first 24 hours
Time Frame
24 hours
Title
Number of blood tests in 72 hours
Time Frame
3 days
Title
Number of blood transfusions during hospital stay
Time Frame
up to 26 weeks
Title
Peripheral arterial line insertion in the first 7 days of life
Time Frame
7 days
Title
PICC line insertion in the first 7 days of life
Time Frame
7 days
Title
Inotropes administered in the first 72 hours of life
Time Frame
3 days
Title
Intubation + Ventilation
Time Frame
Up to 3 days
Title
Surfactant administration
Time Frame
up to 3 days
Title
Necrotizing enterocolitis (Bell's staging)
Time Frame
Up to 3 months
Title
Intraventricular Haemorrhage (Papile classification)
Time Frame
Up to 6 months
Title
Periventricular leukomalacia
Time Frame
Up to 6 months
Title
Chronic lung disease
Time Frame
Up to 3 months
Title
In hospital mortality
Time Frame
Up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Minute
Maximum Age & Unit of Time
60 Minutes
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: inborn infants admitted to the NICU with; gestational age < 29 weeks (up to 28+6 weeks) OR birth weight < 1250g. Exclusion Criteria: end of life (palliative) care large abdominal wall defects imperforate anus.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emma A Dunne, MB BCh BAO
Phone
0877799751
Email
emma.dunne9@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lisa K McCarthy, MB BCh BAO
Phone
0879481569
Email
lmccarthy@nmh.ie
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Colm PF O'Donnell, MB BCh BAO
Organizational Affiliation
The National Maternity Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lisa K McCarthy, MB BCh BAO
Organizational Affiliation
The National Maternity Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Maternity Hospital
City
Dublin
State/Province
Dubiln
ZIP/Postal Code
2
Country
Ireland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa K McCarthy, MB BCh BAO PhD
Phone
016373100
Email
lmccarthy@nmh.ie
First Name & Middle Initial & Last Name & Degree
Emma Dunne
Phone
0877799751
Email
emma.dunne9@gmail.com
First Name & Middle Initial & Last Name & Degree
Colm PF O'Donnell, MB BCh BAO
First Name & Middle Initial & Last Name & Degree
Lisa K McCarthy, MB BCh BAO
First Name & Middle Initial & Last Name & Degree
Emma A Dunne, MB BCh BAO

12. IPD Sharing Statement

Plan to Share IPD
No

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Umbilical or Peripheral Catheter Insertion for Preterm Infants on Admission to the NICU

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