The effect of positioning on the transition from tube to oral feeding in preterm infants: A pilot study

ISRCTN ISRCTN46659438
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

Child Development Centre
St James's University Hospital
Beckett Street
Leeds
LS9 7TF
United Kingdom

Phone +44 (0)113 206 5838
Email kate.jones018@virgin.net

Study information

Study designPilot RCT
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific titleThe effect of positioning on the transition from tube to oral feeding in preterm infants: A pilot study
Study objectivesThe 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) studiedPositioning on the transition from tube to oral feeding in preterm infants
InterventionThis 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 typeOther
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/04/2005
Completion date31/05/2006

Eligibility

Participant type(s)Patient
Age groupNeonate
SexBoth
Target number of participants10
Key inclusion criteriaAt 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 criteria1. 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 enrolment01/04/2005
Date of final enrolment31/05/2006

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Child Development Centre
Leeds
LS9 7TF
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

Bradford South and West Primary Care Trust (UK)

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

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.