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

Plain English Summary

Background and study aims
Many newborn babies receive help for breathing difficulties after birth. Some of these infants are have a tube (an endotracheal tube - ETT) inserted into their windpipe for support with a ventilator. ETTs have markings at 1cm intervals from the tip so that it is known how far it has been inserted. ETTs also have a marker, the vocal cord guide, 2.5 – 3cm from the tip. It is important that the ETT is inserted far enough so that it is within the windpipe, but not too far so that the lungs are not ventilated evenly. The position of the ETT tip is confirmed using a chest X-ray. Currently, doctors estimate how far they should insert ETTs in a newborn using a formula based on the baby’s birth weight. Half of the ETTs are not in the correct position when the insertion depth is estimated using this method. It may be more accurate to use the vocal cord guide. We aim to determine whether estimating the insertion depth of ETTs in newborns with the vocal cord guide, compared to weight, results in more correctly-placed ETTs on chest X-rays.

Who can participate?
Newborn infants who are being intubated (tube inserted) in the Neonatal Intensive Care Unit (NICU) can participate in the study.

What does the study involve?
Newborns are randomly allocated to one of two groups: estimation of ETT insertion depth using the weight-based formula or the vocal cord guide. Correct position of the ETT insertion is found using an X-ray by a specialist.

What are the possible benefits and risks of participating?
Infants will not have additional investigations or treatments by virtue of their participation in the study.
There are no risks in participating above those that already exist due to intubation in an intensive care.

Where is the study run from?
The study is run from the National Maternity Hospital, Holles Street, 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?
The 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

NEDI2001

Study information

Scientific title

Estimating Neonatal oral Endotracheal tube Depth of Insertion using weight or vocal cord guide

Acronym

NEDI2

Study hypothesis

Estimating the appropriate depth of insertion of oral endotracheal tubes (ETT) in newborns using the vocal cord guide is more accurate than using a weight based formula.

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

Diagnostic

Patient information sheet

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

Condition

Neonatal intensive care, respiratory support, mechanical ventilation

Intervention

Newborns are randomised to two groups:
1. Oral ETT insertion depth estimated using a weight-basd formula [insertion depth (cm) = 6 + birth weight (kg)]
2. Operators assessment that the top of the vocal cord guide is still visible

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Correct position of the ETT on chest X-ray defined as between the upper border of the first thoracic vertebra (T1) and the lower border of the second thoracic vertebra (T2) on chest X-ray. ETT position will be determined by a consultant paediatric radiologist who will be unaware of the infant’s treatment allocation.

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

16/09/2013

Overall trial end date

30/06/2014

Reason abandoned

Eligibility

Participant inclusion criteria

Newborn infants intubated in the neonatal intensive care unit (NICU)

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

116

Participant exclusion criteria

Infants with upper airway anomalies (e.g. Pierre-Robin sequence) or lung abnormalities (e.g. congenital diaphragmatic hernia) that may distort the upper airway anatomy and alter the position of the ETT tip on chest X-ray (CXR) are not eligible for inclusion.

Recruitment start date

16/09/2013

Recruitment end date

30/06/2014

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