Condition category
Respiratory
Date applied
21/02/2012
Date assigned
12/06/2012
Last edited
12/06/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Type

Scientific

Primary contact

Dr Colm O'Donnell

ORCID ID

Contact details

The National Maternity Hospital
Holles Street
Dublin
2
Ireland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

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)

Acronym

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

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

Neonatal respiratory support

Intervention

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

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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

10/01/2012

Overall trial end date

30/09/2012

Reason abandoned

Eligibility

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

Patient

Age group

Neonate

Gender

Both

Target number of participants

90

Participant exclusion criteria

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

Recruitment start date

10/01/2012

Recruitment end date

30/09/2012

Locations

Countries of recruitment

Ireland

Trial participating centre

The National Maternity Hospital
Dublin
2
Ireland

Sponsor information

Organisation

The National Maternity Hospital (Ireland)

Sponsor details

c/o Dr. Colm O'Donnell
Holles Street
Dublin
2
Ireland

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

National Children’s Research Centre (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