Condition category
Neonatal Diseases
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
22/09/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Miss Rachelle Mayo

ORCID ID

Contact details

Brighton & Sussex University Hospitals NHS Trust (RA)
Royal Alexandra Childrens Hospital
Dyke Road
Brighton
BN1 3JN
United Kingdom
+44 01273 328156 ext 2143

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0051166168

Study information

Scientific title

Acronym

Study hypothesis

Does nasal intubation give the potential for quicker weaning onto full oral feeds by allowing earlier introduction of odometer exercises, non-nutritive sucking and positive oral experiences?

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial with parallel group comparison - pilot study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Condition

Neonatal diseases

Intervention

This will be a randomised controlled trial with parallel group comparison. Babies will be allocated to either a nasal or an oral intubation group (via a sealed envelope). It is planned that those babies requiring ventilatory support will be intubated at birth by whatever method is considered the safest and most convenient at the time. Intubation tubes are routinely changed during the first week of life, and it is at this stage that the baby will be randomly allocated into either the oral or the nasal intubation group (if parental consent has been given).

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Comparison of weaning onto full oral feeding in nasally intubated vs orally intubated babies
2. Time taken until first oral feed attempted, time taken until first oral feed completed
3. Time taken until 85% feeds are taken orally
4. Length of inpatient stay
5. Weight gain
6. Number of failed procedures, number of tube changes and the reason for change

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/06/2005

Overall trial end date

01/03/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Babies will be eligible for the research if they are: born between 25 and 40+6 weeks gestation, booked within the NHS trust, or transferred to the trust ex utero within the first seven days of life and require ventilatory support.

Participant type

Patient

Age group

Neonate

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Babies will be excluded if they have significant congenital abnormalities, require surgical intervention, have significant neurological anomalies (i.e., Grade III IVH or higher, or any evidence of fitting), or if they only require mechanical ventilation for 24 hours or less.

Recruitment start date

01/06/2005

Recruitment end date

01/03/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Brighton & Sussex University Hospitals NHS Trust (RA)
Brighton
BN1 3JN
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2006 Update - Department of Health

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Brighton and Sussex University Hospitals NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D Support Funding

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