sing birth weight or surface measurements for estimating insertion depth of umbilical catheters in newborn infants
- Conditions
- Critical care of the newborn infantNeonatal Diseases
- Registration Number
- ISRCTN17864069
- Lead Sponsor
- The National Maternity Hospital (Ireland)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 101
1. Infants born at any gestational age at the National Maternity Hospital (NMH) who have umbilical catheter (umbilical venous catheter [UVC] and/or umbilical arterial catheter [UAC]) insertion attempted in the Neonatal Intensive Care Unit (NICU) are eligible for enrolment
2. Infants born outside the NMH and transferred after birth will be eligible for enrollment if they have not had umbilical catheterization at the referring hospital
1. Infants who have previously had a UVC or UAC inserted at a referring hospital
2. Infants with major congenital anomalies or hydrops that may alter the calculated or measured insertion length of the catheters or alter anatomy on x-ray (e.g. gastroschisis, exomphalos or congenital diaphragmatic hernia)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Correct cather position determined by a Consultant Radiologist masked to treatment allocation on a chest and abdominal x-ray defined as:<br><br>UVC - catheter-tip between the upper border of T9 and the lower border of T10<br>UAC - catheter-tip between the upper border of T6 and the lower border of T10
- Secondary Outcome Measures
Name Time Method 1. Number of umbilical line insertions attempted and successful<br>2. Replacement or repositioning of umbilical line post confirmation x-ray<br>3. Total number of x-rays performed to confirm line position<br>4. Complications associated with UVC positioning in the liver<br>5. Pericardial effusions<br>6. Pericardial tamponade<br>7. Pleural effusions<br>8. Air leaks<br>9. Cardiac arrhythmias<br>10. Gastrointestinal perforation<br>11. Necrotising enterocolitis<br>12. Time to 120 mL/kg/day enteral feeds<br>13. Cranial ultrasound abnormalities (intraventricular hemorrhage and periventricular leukomalacia)<br>14. Total duration of umbilical lines in situ (days)<br>15. Catheter-related blood stream infection related to the umbilical line<br>16. Duration of hospital stay (days)<br>17. Death before discharge and at latest follow-up