Nasal intubation influences weaning onto full oral feeds in neonates

ISRCTN	ISRCTN34821939
DOI	https://doi.org/10.1186/ISRCTN34821939
Protocol serial number	N0051166168
Sponsor	Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Funders	Brighton and Sussex University Hospitals NHS Trust (UK), NHS R&D Support Funding

Submission date: 29/09/2006
Registration date: 29/09/2006
Last edited: 22/09/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Neonatal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Miss Rachelle Mayo
Scientific

Brighton & Sussex University Hospitals NHS Trust (RA)
Royal Alexandra Childrens Hospital
Dyke Road
Brighton
BN1 3JN
United Kingdom

Phone	+44 01273 328156 ext 2143

Study information

Primary study design	Interventional
Study design	Randomised controlled trial with parallel group comparison - pilot study
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/03/2006

Eligibility

Participant type(s)	Patient
Age group	Neonate
Sex	Not Specified
Key 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.
Key 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.
Date of first enrolment	01/06/2005
Date of final enrolment	01/03/2006

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Brighton & Sussex University Hospitals NHS Trust (RA)

Brighton
BN1 3JN
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan