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
Protocol serial number	N0626168625
Sponsor	Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Funder	Bradford South and West Primary Care Trust (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

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

Primary study design	Interventional
Study design	Pilot RCT
Secondary study design	Randomised controlled trial
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(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/05/2006

Participant type(s)	Patient
Age group	Neonate
Sex	All
Target sample size at registration	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

Child Development Centre

Leeds
LS9 7TF
United Kingdom

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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Poster results	results poster presentation	10/06/2008		No	No

02/10/2017: internal review.