Placing newborn infants on their Back Or Right side for Umbilical venous catheter (UVC) insertion
| ISRCTN | ISRCTN71265031 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN71265031 |
| Secondary identifying numbers | BORU001 |
- Submission date
- 03/09/2013
- Registration date
- 14/10/2013
- Last edited
- 21/01/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Neonatal Diseases
Plain English summary of protocol
Background and study aims
Some newborn babies have lines inserted into a large blood vessel in their umbilical cord (umbilical venous catheter - UVC) so they can receive fluid, blood products and drugs. It is important that the tip of the UVC is in the midline near the heart so that these products are delivered into a large volume of circulating blood. Babies are placed on their back when UVCs are inserted. The position of the UVC tip is confirmed with an X-ray. Up to half of UVCs inserted into infants lying on the back end up in a smaller blood vessel on the right side near the liver. We aim to find out whether placing babies on the right side results in more UVCs in the correct position on X-rays.
Who can participate?
Newborn infants who are having a UVC inserted can participate in the study.
What does the study involve?
Infants re randomly allocated to one of two groups: being placed on their back or on their right side during UVC insertion. The position of the insertion is analysed using an X-ray.
What are the possible benefits and risks of participating?
Participants will not have extra investigations or treatments due to their participation in the study. There are no risks to participants above those incurred by any infant who has a UVC inserted.
Where is the study run from?
The National Maternity Hospital, Dublin, Ireland.
When is study starting and how long is it expected to run for?
The study started in September 2013 and is expected to run for 12 months.
Who is funding the study?
National Childrens Research Centre, Dublin, Ireland.
Who is the main contact?
Dr Colm ODonnell
codonnell@nmh.ie
Contact information
Scientific
Neonatal Intensive Care Unit
The National Maternity Hospital
Holles Street
Dublin
2
Ireland
| Phone | +353 (1) 637 3100 |
|---|---|
| codonnell@nmh.ie |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A randomised trial of placing newborn infants on their back or right side during umbilical venous catheter insertion |
| Study acronym | BORU |
| Study objectives | Placing newborn infants who are having umbilical venous catheters inserted on their right side, compared to the back, results in an increased rate of correctly sited umbilical venous catheters. On 04/06/2014 the anticipated end date was changed from 30/06/2014 to 30/05/2014. |
| Ethics approval(s) | Ethics Committee at the National Maternity Hospital, Dublin, Ireland; 25/06/2013 |
| Health condition(s) or problem(s) studied | Critical care of the newborn infant |
| Intervention | 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. 2. Infants who are randomised to right side shall be turned 90 degrees onto the right side and then have the UVC inserted. Once the UVC is in place all infants shall be placed back on their back. UVCs will be sutured in place and the position will be determined with a chest and abdominal X-ray. |
| Intervention type | Other |
| Primary outcome measure | 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 infants group assignment. |
| Secondary outcome measures | 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 |
| Overall study start date | 16/09/2013 |
| Completion date | 30/05/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | 88 |
| Key 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 |
| Key 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) |
| Date of first enrolment | 16/09/2013 |
| Date of final enrolment | 30/05/2014 |
Locations
Countries of recruitment
- Ireland
Study participating centre
2
Ireland
Sponsor information
Hospital/treatment centre
c/o Colm O'Donnell
Neonatal Intensive Care Unit
Holles Street
Dublin
2
Ireland
"ROR" |
https://ror.org/03jcxa214 |
|---|
Funders
Funder type
Research organisation
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/10/2016 | 21/01/2019 | Yes | No |
Editorial Notes
21/01/2019: Publication reference added
