The effect of positioning on the transition from tube to oral feeding in preterm infants: A pilot study
ISRCTN | ISRCTN46659438 |
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DOI | https://doi.org/10.1186/ISRCTN46659438 |
Secondary identifying numbers | N0626168625 |
- Submission date
- 29/09/2006
- Registration date
- 29/09/2006
- Last edited
- 02/10/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Neonatal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mrs Kate Jones
Scientific
Scientific
Child Development Centre
St James's University Hospital
Beckett Street
Leeds
LS9 7TF
United Kingdom
Phone | +44 (0)113 206 5838 |
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kate.jones018@virgin.net |
Study information
Study design | Pilot RCT |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Not Specified |
Scientific title | The effect of positioning on the transition from tube to oral feeding in preterm infants: A pilot study |
Study objectives | The effect of positioning on the transition from tube to oral feeding in preterm infants: A pilot study. |
Ethics approval(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | 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 |
Primary outcome measure | Not provided at time of registration |
Secondary outcome measures | Not provided at time of registration |
Overall study start date | 01/04/2005 |
Completion date | 31/05/2006 |
Eligibility
Participant type(s) | Patient |
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Age group | Neonate |
Sex | Both |
Target number of participants | 10 |
Key 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. |
Key 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. |
Date of first enrolment | 01/04/2005 |
Date of final enrolment | 31/05/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Child Development Centre
Leeds
LS9 7TF
United Kingdom
LS9 7TF
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 |
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dhmail@doh.gsi.org.uk | |
Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Bradford South and West Primary Care Trust (UK)
No information available
Results and Publications
Intention to publish date | |
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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 |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Poster results | results poster presentation | 10/06/2008 | No | No |
Editorial Notes
02/10/2017: internal review.