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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04761484
Other study ID # APOLLO_UP
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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