Condition category
Neonatal Diseases
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
01/11/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes