Contact information
Type
Scientific
Primary contact
Mrs Kate Jones
ORCID ID
Contact details
Child Development Centre
St James's University Hospital
Beckett Street
Leeds
LS9 7TF
United Kingdom
+44 (0)113 206 5838
kate.jones018@virgin.net
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0626168625
Study information
Scientific title
Acronym
Study hypothesis
The effect of positioning on the transition from tube to oral feeding in preterm infants: A pilot study.
Ethics approval
Not provided at time of registration
Study design
Pilot RCT
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Positioning on the transition from tube to oral feeding in preterm infants
Intervention
This pilot study will take place on a local neonatal unit and will examine the bottle feeding skills of premature infants whilst they are being fed either an elevated side-lying position, or a traditional semi-upright position. Infants will be studied from the time that oral feeds are first introduced until the infant is taking all bottle feeds and the nasogastric tube is no longer required.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/04/2005
Overall trial end date
31/05/2006
Reason abandoned
Eligibility
Participant inclusion criteria
At the time of first introduction to oral feeds, preterm infants (infants born with a gestational age of 36 completed weeks or less) will be randomly allocated to either the intervention or the control group. Randomisation will be my means of sealed envelopes containing either the words elevated side-lying position or traditional position. The aim is to have five participants in each group.
Participant type
Patient
Age group
Neonate
Gender
Both
Target number of participants
10
Participant exclusion criteria
1. Infants will be excluded if they are medically unstable
2. Have either a cleft lip or palate
3. Have identified neurological symptoms
4. Have congenital anomalies
5. Have known maternal substance abuse
6. Are to be discharged to other wards of hospitals before full oral feeding has been established
7. Have a gestational age of 37 weeks or above
8. Are being breastfed
9. If it is not possible to explain the study adequately so that informed consent can be obtained then those infants will be excluded from the study. Informed consent will be obtained from the infants carers by either the researcher or a senior member of the nursing staff.
Recruitment start date
01/04/2005
Recruitment end date
31/05/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Child Development Centre
Leeds
LS9 7TF
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
Bradford South and West Primary Care Trust (UK)
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
2008 results poster presentation in http://fn.bmj.com/content/93/Suppl_1/Fa80.extract