Nasal intubation influences weaning onto full oral feeds in neonates
| ISRCTN | ISRCTN34821939 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN34821939 |
| Secondary identifying numbers | N0051166168 |
- 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
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
| Study design | Randomised controlled trial with parallel group comparison - pilot study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Other |
| 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 | 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 study start date | 01/06/2005 |
| Completion date | 01/03/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| 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
- England
- United Kingdom
Study participating centre
Brighton & Sussex University Hospitals NHS Trust (RA)
Brighton
BN1 3JN
United Kingdom
BN1 3JN
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government
Government
The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Brighton and Sussex University Hospitals NHS Trust (UK)
No information available
NHS R&D Support Funding
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
