Ignite Creation Date:
2024-05-06 @ 3:49 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04761484
Status:
UNKNOWN
Last Update Posted:
2021-04-28
First Post:
2021-02-09
Brief Title:
Umbilical or Peripheral Catheter Insertion for Preterm Infants on Admission to the NICU
Sponsor:
University College Dublin
Organization:
University College Dublin
Study Overview
Official Title:
A Randomised Trial of Umbilical or Peripheral Catheter Insertion for Preterm Infants on NICU Admission
Status:
UNKNOWN
Status Verified Date:
2021-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
UP
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 andor UAC will increase the proportion of infants with a rectal temperature in the normal range at 2 hours of life
The investigators think that in extremely preterm infants placing a peripheral intravenous cannula on admission to the NICU instead of umbilical catheters UVC andor 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 newborns1 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 365 oC on admission to the NICU2
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 mayoften involves 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 1926 73 had an abnormal temperature at the beginning of the procedure and 1726 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 360oC before and 11 42 after the procedure The median duration of procedure was 53 37 73 minutes3
The investigators think that in extremely preterm infants placing a peripheral intravenous cannula on admission to the NICU instead of umbilical catheters UVC andor UAC will increase the proportion of infants with a rectal temperature in the normal range at 2 hours of life
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 mayoften involves 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 1926 73 had an abnormal temperature at the beginning of the procedure and 1726 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 360oC before and 11 42 after the procedure The median duration of procedure was 53 37 73 minutes3
The investigators think that in extremely preterm infants placing a peripheral intravenous cannula on admission to the NICU instead of umbilical catheters UVC andor UAC will increase the proportion of infants with a rectal temperature in the normal range at 2 hours of life
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None