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

A Randomised Trial of Umbilical or Peripheral Catheter Insertion for Preterm Infants on NICU Admission

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.

Study Overview

• Status: Recruiting
• Conditions: Preterm Birth Complication; Neonatal Hypothermia; Hypothermia, Newborn
• Intervention / Treatment: Procedure: Vascular access on admission

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.

• Study Type: Interventional
• Enrollment (Anticipated): 116
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emma A Dunne, MB BCh BAO; Phone Number: 0877799751; Email: emma.dunne9@gmail.com
• Study Contact Backup: Name: Lisa K McCarthy, MB BCh BAO; Phone Number: 0879481569; Email: lmccarthy@nmh.ie

Study Locations

• Ireland
  • Dubiln
    • Dublin, Dubiln, Ireland, 2
      • Recruiting
      • National Maternity Hospital
      • Contact: Emma Dunne; Phone Number: 0877799751; Email: emma.dunne9@gmail.com
      • Sub-Investigator: Colm PF O'Donnell, MB BCh BAO
      • Principal Investigator: Lisa K McCarthy, MB BCh BAO
      • Sub-Investigator: Emma A Dunne, MB BCh BAO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 minute to 1 hour (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention; Insertion of peripheral venous catheter on admission to the NICU	Procedure: Vascular access on admission; PIVC insertion
NO_INTERVENTION: Control; Insertion of and umbilical venous catheter on admission

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Core (rectal) temperature 2 hours after birth	Core (rectal) temperature 2 hours after birth	2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Number (%) lines used without repositioning		up to 24 hours
Number (%) lines repositioned		up to 24 hours
Number (%) of low lying umbilical venous catheters		up to 24 hours
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)	up to 24 hours
Number of peripheral line attempts		up to 24 hours
Number (%) of infants in whom PIVC as first point of access was unsuccessful (nothing was infused through the line)		24 hours
Complications of line insertion/placement		10 days
Blood stream infections (CRBSI)		up to 16 weeks
Number of x-rays performed in first 24 hours		24 hours
Blood sampling in first 24 hours		24 hours
Number of blood tests in 72 hours		3 days
Number of blood transfusions during hospital stay		up to 26 weeks
Peripheral arterial line insertion in the first 7 days of life		7 days
PICC line insertion in the first 7 days of life		7 days
Inotropes administered in the first 72 hours of life		3 days
Intubation + Ventilation		Up to 3 days
Surfactant administration		up to 3 days
Necrotizing enterocolitis (Bell's staging)		Up to 3 months
Intraventricular Haemorrhage (Papile classification)		Up to 6 months
Periventricular leukomalacia		Up to 6 months
Chronic lung disease		Up to 3 months
In hospital mortality		Up to 6 months

Collaborators and Investigators

• Sponsor: University College Dublin
• Collaborators: Irish Research Council
• Investigators: Principal Investigator: Colm PF O'Donnell, MB BCh BAO, The National Maternity Hospital; Principal Investigator: Lisa K McCarthy, MB BCh BAO, The National Maternity Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2021
• Primary Completion (ANTICIPATED): July 1, 2022
• Study Completion (ANTICIPATED): October 1, 2022

Study Registration Dates

• First Submitted: February 9, 2021
• First Submitted That Met QC Criteria: February 17, 2021
• First Posted (ACTUAL): February 21, 2021

Study Record Updates

• Last Update Posted (ACTUAL): April 28, 2021
• Last Update Submitted That Met QC Criteria: April 27, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Body Temperature Changes; Premature Birth; Hypothermia
• Other Study ID Numbers: APOLLO_UP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No