Condition category
Neonatal Diseases
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
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

Trial website

Contact information



Primary contact

Dr Colm O'Donnell


Contact details

Neonatal Intensive Care Unit
The National Maternity Hospital
Holles Street
+353 (1) 637 3100

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

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



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


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

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


Critical care of the newborn infant


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



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


Overall trial end date


Reason abandoned


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


Age group




Target number of participants


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


Recruitment end date



Countries of recruitment


Trial participating centre

Neonatal Intensive Care Unit

Sponsor information


The National Maternity Hospital (Ireland)

Sponsor details

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

Sponsor type

Hospital/treatment centre



Funder type

Research organisation

Funder name

National Children's Research Centre, Dublin, Ireland

Alternative name(s)

Funding Body Type

Funding Body Subtype


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