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
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