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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hypothermia, Newborn, Preterm Birth Complication, Neonatal Hypothermia

Intervention / Treatment
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* Procedure: Vascular access on admission


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 1 Minute
Maximum Age: 60 Minutes

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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]).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Insertion of peripheral venous catheter on admission to the NICU | Procedure: Vascular access on admission<br>* PIVC insertion<br>|
| No Intervention: Control<br>Insertion of and umbilical venous catheter on admission | |

What is the study measuring?
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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 |