Condition category
Neonatal Diseases
Date applied
03/09/2013
Date assigned
14/10/2013
Last edited
04/06/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Colm O'Donnell

ORCID ID

Contact details

Neonatal Intensive Care Unit
The National Maternity Hospital
Holles Street
Dublin
2
Ireland
+353 (1) 637 3100
codonnell@nmh.ie

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

BORU001

Study information

Scientific title

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

Acronym

BORU

Study hypothesis

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

Ethics Committee at the National Maternity Hospital, Dublin, Ireland; 25/06/2013

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 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 trial start date

16/09/2013

Overall trial end date

30/05/2014

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

88

Participant 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)

Recruitment start date

16/09/2013

Recruitment end date

30/05/2014

Locations

Countries of recruitment

Ireland

Trial participating centre

Neonatal Intensive Care Unit
Dublin
2
Ireland

Sponsor information

Organisation

The National Maternity Hospital (Ireland)

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Research organisation

Funder name

National Children's Research Centre, Dublin, Ireland

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes