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Placing newborn infants on their Back Or Right side for Umbilical venous catheter (UVC) insertion

A randomised trial of placing newborn infants on their back or right side during umbilical venous catheter insertion

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN71265031
Enrollment
88
Registered
2013-10-14
Start date
2013-09-16
Completion date
Unknown
Last updated
2019-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical care of the newborn infant Neonatal Diseases

Interventions

Infants will be randomly allocated to the 'right side' or 'back' groups. 1. Infants randomised to back positioning will remain on their back and have the UVC inserted.

Sponsors

The National Maternity Hospital (Ireland)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Infants will be eligible for enrollment in this study if they are having a UVC inserted in the Neonatal Intensive Care Unit (NICU) 2. Infants born outside the National Maternity Hospital will be eligible for enrollment if they have not undergone umbilical catheterization in the referring hospital

Exclusion criteria

Exclusion criteria: 1. Infants who have previously had a UVC inserted at a referring hospital 2. Infants with major congenital anomalies that may alter internal anatomy (e.g. gastroschisis, exomphalos or congenital diaphragmatic hernia)

Design outcomes

Primary

MeasureTime frame
Correct placement of the UVC defined as the catheter-tip being in the midline at diaphragm level on the X-ray taken to confirm catheter position. The position of the catheter tip will be determined by a consultant radiologist who is masked to the infant?s group assignment.

Secondary

MeasureTime frame
1. The successful insertion of the UVC 2. Corresponding vertebral level of UVC tip on X-ray 3. Number of UVC insertion attempts and successful 4. Replacement or repositioning of UVC post confirmation X-ray 5. Total number of x-rays performed to confirm line position 6. Pericardial effusions 7. Pleural effusions 8. Air leaks 9. Cardiac arrhythmias 10. Gastrointestinal perforation 11. Necrotising enterocolitis 12. Time to 120 ml/kg/day enteral feeds 13. Cranial ultrasound abnormalities (intraventricular hemorrhage and periventricular leukomalacia) 14. Total duration of umbilical catheters in situ (days) 15. Catheter related blood stream infection 16. Duration of hospital stay (days) 17. Death before discharge

Countries

Ireland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026