Condition category
Neonatal Diseases
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
05/10/2011
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

Speech and Language Therapy
Child Development Centre
3rd Floor
Oaktree House
408 Oakwood Lane
Leeds
LS8 3LG
United Kingdom
+44
Kate.jones018@virgin.net

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0436165577

Study information

Scientific title

Acronym

Study hypothesis

This pilot study aims to look at two small groups of preterm infants as they progress from nasogastric tube feeds to oral feeds and determine whether positioning the infants in side-lying enables a smoother transition to occur.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Neonatal Diseases

Intervention

Positioning technique 1 vs positioning technique 2

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The primary outcome measure is the time taken (in days) to attain full oral feeding. This is defined as the number of days necessary to make the transition from full nasogastric feeding to full oral feeding.

Secondary outcome measures

Secondary outcomes include a measure of oxygen desaturation events and a measure of the time (in days) taken until supplemental oxygen is no longer required (for those infants needing supplemental oxygen at the start of the study).

Overall trial start date

01/03/2005

Overall trial end date

27/03/2006

Reason abandoned

Eligibility

Participant inclusion criteria

The pilot study will examine preterm infants (infants born with a gestational age of 36 completed weeks or less).

Participant type

Patient

Age group

Neonate

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Infants will be excluded if they are medically unstable, have either a cleft lip or palate, have identified neurological symptoms, have congenital anomalies, have known maternal substance abuse, will be discharged to other neonatal units before full oral feeding is established have a gestational age of 37 weeks or above or who are breastfed.

Recruitment start date

01/03/2005

Recruitment end date

27/03/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Speech and Language Therapy
Leeds
LS8 3LG
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

Leeds Teaching Hospitals NHS Trust (UK), NHS R&D Support Funding

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

No publication intended as of 08/09/2008

Publication citations

Additional files

Editorial Notes