Umbilical or Peripheral Catheter Insertion for Preterm Infants on Admission to the NICU
- Conditions
- Neonatal HypothermiaHypothermia, NewbornPreterm Birth Complication
- Interventions
- Procedure: Vascular access on admission
- Registration Number
- NCT04761484
- Lead Sponsor
- University College Dublin
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 116
- inborn infants admitted to the NICU with;
- gestational age < 29 weeks (up to 28+6 weeks) OR
- birth weight < 1250g.
- end of life (palliative) care
- large abdominal wall defects
- imperforate anus.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Vascular access on admission Insertion of peripheral venous catheter on admission to the NICU
- Primary Outcome Measures
Name Time Method Core (rectal) temperature 2 hours after birth 2 hours Core (rectal) temperature 2 hours after birth
- Secondary Outcome Measures
Name Time Method Inotropes administered in the first 72 hours of life 3 days 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 up to 24 hours 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)
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 Number (%) lines repositioned up to 24 hours Axillary temperature at the end of the procedure up to 24 hours Time to completion of procedure (incubator roof down, portholes closed and hands off) up to 24 hours Mean difference in axillary temperature from admission to end of procedure up to 24 hours Number of peripheral line attempts up to 24 hours Blood stream infections (CRBSI) up to 16 weeks Number of x-rays performed in first 24 hours 24 hours Number of blood transfusions during hospital stay up to 26 weeks PICC line insertion in the first 7 days of life 7 days Intubation + Ventilation Up to 3 days Necrotizing enterocolitis (Bell's staging) Up to 3 months Periventricular leukomalacia Up to 6 months Time to first intravenous infusion starting (PN / dextrose / antibiotics / caffeine) up to 24 hours Blood sampling in first 24 hours 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 of blood tests in 72 hours 3 days Peripheral arterial line insertion in the first 7 days of life 7 days Surfactant administration up to 3 days Intraventricular Haemorrhage (Papile classification) Up to 6 months Chronic lung disease Up to 3 months In hospital mortality Up to 6 months
Trial Locations
- Locations (1)
National Maternity Hospital
🇮🇪Dublin, Dubiln, Ireland