Condition category
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Background and study aims
Newborn babies who have difficulty breathing after birth are often supported with a ventilator (respirator). Babies are ventilated through a plastic tube called an endotracheal tube (ETT) which is inserted into the trachea (windpipe) through the mouth. ETTs are marked each centimetre along their length from the tip so that it is known how far from the baby's lips the tube has been inserted. It is important that the tip of the ETT is correctly positioned in the trachea above the carina (the point where it divides to supply the left and right lung) so that support is given evenly to both lungs. Most doctors estimate how far they should insert the ETT using the baby's weight. Studies suggest that estimating the depth of insertion using their gestational age may be more accurate. We aim to determine which method is more accurate.

Who can participate?
Newborn babies who are having an ETT inserted for respiratory support in the Neonatal Intensive Care Unit (NICU).

What does the study involve?
Babies enrolled in this study will have the depth of insertion of the ETT estimated using either their gestational age or their birth weight.

What are the possible benefits and risks of participating?
One group may have a higher proportion of correctly placed ETTs. There are no more risks above those inherent in needing intubation and ventilation

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 on 10/01/2012 and we estimate that it will run for 1 year.

Who is funding the study?
National Children's Research Centre (Ireland)

Who is the main contact?
Dr Colm O’Donnell

Trial website

Contact information



Primary contact

Dr Colm O'Donnell


Contact details

The National Maternity Hospital
Holles Street

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

A randomised controlled trial comparing the use of gestational age or weight to estimate Neonatal Endotracheal tube Depth of Insertion (NEDI)



Study hypothesis

Compared to using a newborn infant's weight, using the gestational age to estimate the appropriate depth of insertion of an oral endotracheal tube (ETT) will result in more correctly placed ETTs on chest X-ray (i.e. tip of ETT between upper border of the first thoracic vertebra, T1, and the lower border of the second thoracic vertebra, T2)

Ethics approval

Ethics Committee at The National Maternity Hospital, Holles Street, Dublin, Ireland, 30/11/2011, ref: NEDI001

Study design

Single centre randomised 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 to request a patient information sheet


Neonatal respiratory support


Infants in both treatment arms will have an endotracheal tube placed via the mouth

Infants randomised to WEIGHT will have the ETT secured at the lips at a depth determined by the formula Insertion Depth (cm) = 6 + (birth weight, kg)

Infants randomised to GESTATIONAL AGE will have the ETT secured at the lips at a depth determined by the following table
ETT length at lip (cm) Corrected gestation (weeks)
5.5 23 – 24
6.0 25 – 26
6.5 27 – 29
7.0 30 – 32
7.5 33 – 34
8.0 35 – 37
8.5 38 – 40
9.0 41 – 43

Intervention type



Not Applicable

Drug names

Primary outcome measure

Endotracheal tube (ETT) tip between the upper border of the 1st thoracic vertebra (T1) and the lower border of the second thoracic vertebra (T2) on chest X-ray

Secondary outcome measures

1. Number of extubations before chest x-ray
2. Repositioning of ETT following chest x-ray
3. Unequal lung expansion on initial chest x-ray following intubation
4. Air leaks - pneumothorax, pneumomediastinum, pulmonary interstitial emphysema
5. Duration of ventilation
6. Oxygen therapy at 28 days
7. Oxygen at 36 weeks
8. Death before discharge from hospital

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

Newly born infants [term (> or = 37 weeks' gestation) or preterm (< 37 weeks' gestation)] who are intubated in the neonatal intensive care unit

Participant type


Age group




Target number of participants


Participant exclusion criteria

Infants with known upper airway (e.g. Pierre-Robin sequence) or lung (congenital diaphragmatic hernia) anomalies

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

The National Maternity Hospital

Sponsor information


The National Maternity Hospital (Ireland)

Sponsor details

c/o Dr Colm O'Donnell
Holles Street

Sponsor type

Hospital/treatment centre



Funder type

Hospital/treatment centre

Funder name

National Children's Research Centre (Ireland)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

IPD sharing statement
The datasets generated and analysed in this study are available upon request from Prof. Colm O’Donnell for a period of 5 years. Consent for sharing this data from the participants’ parent(s)/guardian(s) was not specifically sought at the time of study entry. The decision whether to share anonymised data will be made based on a description of the purpose for which the data is sought, and the types of planned analyses

Intention to publish date

Participant level data

Available on request

Basic results (scientific)

Publication list

2015 results in: [added 16/01/2019]

Publication citations

Additional files

Editorial Notes

17/01/2019: IPD sharing statement added. 16/01/2019: Publication reference added.