NCT04761484

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 116 (estimated)
• Sponsor: University College Dublin · Academic / Other
• Sex: All
• Age: 1 Minute – 60 Minutes
• Healthy volunteers: Accepted

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.

Conditions

• Hypothermia, Newborn
• Preterm Birth Complication
• Neonatal Hypothermia

Interventions

Type	Name	Description
PROCEDURE	Vascular access on admission	PIVC insertion

Timeline

• Start date: 2021-03-01
• Primary completion: 2022-07-01
• Completion: 2022-10-01
• First posted: 2021-02-21
• Last updated: 2021-04-28

Locations

1 site across 1 country: Ireland