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

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 designRandomised controlled trial with parallel group comparison - pilot study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeOther
Scientific title
Study objectivesDoes 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) studiedNeonatal diseases
InterventionThis 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 typeOther
Primary outcome measure1. 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 measuresNot provided at time of registration
Overall study start date01/06/2005
Completion date01/03/2006

Eligibility

Participant type(s)Patient
Age groupNeonate
SexNot Specified
Target number of participantsNot provided at time of registration
Key inclusion criteriaBabies 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 criteriaBabies 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 enrolment01/06/2005
Date of final enrolment01/03/2006

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

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

Sponsor information

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

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email 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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan