Clinical trial NCT04761484: Umbilical or Peripheral Catheter Insertion for Preterm Infants on Admission to the NICU
Official title: A Randomised Trial of Umbilical or Peripheral Catheter Insertion for Preterm Infants on NICU Admission
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypothermia, Newborn
Preterm Birth Complication
Neonatal Hypothermia
Lead sponsor: University College Dublin
Sponsor class: OTHER
Collaborators: name: Irish Research Council
First posted: 2021-02-21
Enrollment: 116
Sex: ALL
Minimum age (years): 1
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 \[\<36.5oC or \>37.5oC\]).
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Core (rectal) temperature 2 hours after birth
timeFrame: 2 hours
Secondary outcomes:
measure: Axillary temperature at the end of the procedure
timeFrame: up to 24 hours
measure: Mean difference in axillary temperature from admission to end of procedure
timeFrame: up to 24 hours
measure: Time to completion of procedure (incubator roof down, portholes closed and hands off)
timeFrame: up to 24 hours
measure: Time to first intravenous infusion starting (PN / dextrose / antibiotics / caffeine)
timeFrame: up to 24 hours
measure: Number (%) infants that have umbilical catheters inserted during their admission
timeFrame: up to 24 hours
measure: Number (%) lines used without repositioning
timeFrame: up to 24 hours
measure: Number (%) lines repositioned
timeFrame: up to 24 hours
measure: Number (%) of low lying umbilical venous catheters
timeFrame: up to 24 hours
measure: Number (%) of infants' in whom attempted placement of an umbilical line was not successful
timeFrame: up to 24 hours
measure: Number of peripheral line attempts
timeFrame: up to 24 hours
measure: Number (%) of infants in whom PIVC as first point of access was unsuccessful (nothing was infused through the line)
timeFrame: 24 hours
measure: Complications of line insertion/placement
timeFrame: 10 days
measure: Blood stream infections (CRBSI)
timeFrame: up to 16 weeks
measure: Number of x-rays performed in first 24 hours
timeFrame: 24 hours
measure: Blood sampling in first 24 hours
timeFrame: 24 hours
measure: Number of blood tests in 72 hours
timeFrame: 3 days
measure: Number of blood transfusions during hospital stay
timeFrame: up to 26 weeks
measure: Peripheral arterial line insertion in the first 7 days of life
timeFrame: 7 days
measure: PICC line insertion in the first 7 days of life
timeFrame: 7 days
measure: Inotropes administered in the first 72 hours of life
timeFrame: 3 days
measure: Intubation + Ventilation
timeFrame: Up to 3 days
measure: Surfactant administration
timeFrame: up to 3 days
measure: Necrotizing enterocolitis (Bell's staging)
timeFrame: Up to 3 months
measure: Intraventricular Haemorrhage (Papile classification)
timeFrame: Up to 6 months
measure: Periventricular leukomalacia
timeFrame: Up to 6 months
measure: Chronic lung disease
timeFrame: Up to 3 months
measure: In hospital mortality
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: National Maternity Hospital
state: Dubiln
Study officials:
affiliation: The National Maternity Hospital
name: Colm PF O'Donnell, MB BCh BAO
role: PRINCIPAL_INVESTIGATOR
affiliation: The National Maternity Hospital
name: Lisa K McCarthy, MB BCh BAO
role: PRINCIPAL_INVESTIGATOR
References: