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

Preterm Birth Complication Clinical Trial

— UP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04761484
• Other study ID #: APOLLO_UP
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: October 2022

Study information

• Verified date: April 2021
• Source: University College Dublin
• Contact: Emma A Dunne, MB BCh BAO
• Phone: 0877799751
• Email: emma.dunne9[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 116
• Est. completion date: October 2022
• Est. primary completion date: July 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 60 Minutes

Eligibility

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.

Related Conditions & MeSH terms

• Hypothermia
• Hypothermia, Newborn
• Neonatal Hypothermia
• Premature Birth
• Preterm Birth Complication

Intervention

Procedure:
• Vascular access on admission
PIVC insertion

Locations

Country	Name	City	State
Ireland	National Maternity Hospital	Dublin	Dubiln

Sponsors (2)

Lead Sponsor	Collaborator
University College Dublin	Irish Research Council

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Core (rectal) temperature 2 hours after birth	Core (rectal) temperature 2 hours after birth	2 hours
Secondary	Axillary temperature at the end of the procedure		up to 24 hours
Secondary	Mean difference in axillary temperature from admission to end of procedure		up to 24 hours
Secondary	Time to completion of procedure (incubator roof down, portholes closed and hands off)		up to 24 hours
Secondary	Time to first intravenous infusion starting (PN / dextrose / antibiotics / caffeine)		up to 24 hours
Secondary	Number (%) infants that have umbilical catheters inserted during their admission		up to 24 hours
Secondary	Number (%) lines used without repositioning		up to 24 hours
Secondary	Number (%) lines repositioned		up to 24 hours
Secondary	Number (%) of low lying umbilical venous catheters		up to 24 hours
Secondary	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
Secondary	Number of peripheral line attempts		up to 24 hours
Secondary	Number (%) of infants in whom PIVC as first point of access was unsuccessful (nothing was infused through the line)		24 hours
Secondary	Complications of line insertion/placement		10 days
Secondary	Blood stream infections (CRBSI)		up to 16 weeks
Secondary	Number of x-rays performed in first 24 hours		24 hours
Secondary	Blood sampling in first 24 hours		24 hours
Secondary	Number of blood tests in 72 hours		3 days
Secondary	Number of blood transfusions during hospital stay		up to 26 weeks
Secondary	Peripheral arterial line insertion in the first 7 days of life		7 days
Secondary	PICC line insertion in the first 7 days of life		7 days
Secondary	Inotropes administered in the first 72 hours of life		3 days
Secondary	Intubation + Ventilation		Up to 3 days
Secondary	Surfactant administration		up to 3 days
Secondary	Necrotizing enterocolitis (Bell's staging)		Up to 3 months
Secondary	Intraventricular Haemorrhage (Papile classification)		Up to 6 months
Secondary	Periventricular leukomalacia		Up to 6 months
Secondary	Chronic lung disease		Up to 3 months
Secondary	In hospital mortality		Up to 6 months