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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

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 Children’s Research Centre, Dublin, Ireland.

Who is the main contact?
Dr Colm O’Donnell
codonnell@nmh.ie

Contact information

Dr Colm O'Donnell
Scientific

Neonatal Intensive Care Unit
The National Maternity Hospital
Holles Street
Dublin
2
Ireland

Phone +353 (1) 637 3100
Email codonnell@nmh.ie

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA randomised trial of placing newborn infants on their back or right side during umbilical venous catheter insertion
Study acronymBORU
Study objectivesPlacing 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) studiedCritical care of the newborn infant
InterventionInfants 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 typeOther
Primary outcome measureCorrect 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 outcome measures1. 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 date16/09/2013
Completion date30/05/2014

Eligibility

Participant type(s)Patient
Age groupNeonate
SexBoth
Target number of participants88
Key inclusion criteria1. 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 criteria1. 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 enrolment16/09/2013
Date of final enrolment30/05/2014

Locations

Countries of recruitment

  • Ireland

Study participating centre

Neonatal Intensive Care Unit
Dublin
2
Ireland

Sponsor information

The National Maternity Hospital (Ireland)
Hospital/treatment centre

c/o Colm O'Donnell
Neonatal Intensive Care Unit
Holles Street
Dublin
2
Ireland

ROR logo "ROR" https://ror.org/03jcxa214

Funders

Funder type

Research organisation

National Children's Research Centre, Dublin, Ireland

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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