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

ISRCTN	ISRCTN37521560
DOI	https://doi.org/10.1186/ISRCTN37521560
Protocol serial number	N0436165577
Sponsor	Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Funder	Leeds Teaching Hospitals NHS Trust (UK), NHS R&D Support Funding

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Mrs Kate Jones
Scientific

Speech and Language Therapy
Child Development Centre
3rd Floor, Oaktree House
408 Oakwood Lane
Leeds
LS8 3LG
United Kingdom

Phone	+44
Email	Kate.jones018@virgin.net

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Neonatal Diseases
Intervention	Positioning technique 1 vs positioning technique 2
Intervention type	Other
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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).
Completion date	27/03/2006

Participant type(s)	Patient
Age group	Neonate
Sex	Not Specified
Key inclusion criteria	The pilot study will examine preterm infants (infants born with a gestational age of 36 completed weeks or less).
Key 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.
Date of first enrolment	01/03/2005
Date of final enrolment	27/03/2006

Speech and Language Therapy

Leeds
LS8 3LG
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan