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

NCT04761484 | Unknown DMC

• 1 other identifier: APOLLO_UP
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypothermia, Newborn; Preterm Birth Complication; Neonatal Hypothermia

Outcome Measures

Primary Outcomes (1)

• Core (rectal) temperature 2 hours after birth

  Core (rectal) temperature 2 hours after birth

  2 hours

Secondary Outcomes (27)

• Axillary temperature at the end of the procedure

  up to 24 hours

• Mean difference in axillary temperature from admission to end of procedure

  up to 24 hours

• Time to completion of procedure (incubator roof down, portholes closed and hands off)

  up to 24 hours

• Time to first intravenous infusion starting (PN / dextrose / antibiotics / caffeine)

  up to 24 hours

• Number (%) infants that have umbilical catheters inserted during their admission

  up to 24 hours

Study Arms (2)

Intervention

EXPERIMENTAL

Insertion of peripheral venous catheter on admission to the NICU

Procedure: Vascular access on admission

Control

NO INTERVENTION

Insertion of and umbilical venous catheter on admission

Interventions

Vascular access on admission PROCEDURE

PIVC insertion

Intervention

Eligibility Criteria

• Age: 1 Minute - 60 Minutes
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University College Dublin: lead
• Irish Research Council: collaborator

Study Sites (1)

National Maternity Hospital

Dublin, Dubiln, 2, Ireland

RECRUITING

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Colm PF O'Donnell, MB BCh BAO

  The National Maternity Hospital

  PRINCIPAL INVESTIGATOR

• Lisa K McCarthy, MB BCh BAO

  The National Maternity Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emma A Dunne, MB BCh BAO

CONTACT

0877799751; emma.dunne9@gmail.com

Lisa K McCarthy, MB BCh BAO

CONTACT

0879481569; lmccarthy@nmh.ie

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 \[\<36.5oC or \>37.5oC\]).

Study Record Dates

• First Submitted: February 9, 2021
• First Posted: February 21, 2021
• Study Start: March 1, 2021
• Primary Completion: July 1, 2022
• Study Completion: October 1, 2022
• Last Updated: April 28, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)