Additional identifiers
EudraCT number
2005-000302-31
ClinicalTrials.gov number
Protocol/serial number
04/S0101/37 (EudraCT number 2005-000302-31)
Study information
Scientific title
Acronym
Study hypothesis
Does the use of regular glycerine suppositories shorten the time to first achievement of full enteral feeds in preterm, very low birth-weight infants?
Ethics approval
Awaiting final approval
Study design
Prospective, open, randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Condition
Feeding problems related to prematurity
Intervention
Glycerine suppositories, control group will receive usual neonetal care following randomisation
Intervention type
Drug
Phase
Not Specified
Drug names
Glycerine suppositories
Primary outcome measure
Time to achieve first full enteral feeds
Secondary outcome measures
1. Number of episodes of abdominal distention
2. Oxygen requirements
3. Development of NEC
4. Episodes of sepsis
5. Growth
Overall trial start date
06/02/2006
Overall trial end date
06/02/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
All preterm babies born at Wishaw General Hospital at less than 32 weeks gestation
Participant type
Patient
Age group
Neonate
Gender
Both
Target number of participants
28
Participant exclusion criteria
Babies with any of the following will be excluded:
1. Major dysmorphic features
2. Any structural gastrointestinal anomaly present
3. Necrotising enterocolitis (NEC)
4. Perinatal hypoxic ischemia
5. Encephalopathy
Recruitment start date
06/02/2006
Recruitment end date
06/02/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Wishaw General Hospital
Wishaw
ML2 0DP
United Kingdom
Funders
Funder type
Government
Funder name
NHS Lanarkshire Primary Care Operating Division 04/S0101/37
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
Basic results (scientific)
Publication list
2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21455007
Publication citations
-
Results
Khadr SN, Ibhanesebhor SE, Rennix C, Fisher HE, Manjunatha CM, Young D, Abara RC, Randomized controlled trial: impact of glycerin suppositories on time to full feeds in preterm infants., Neonatology, 2011, 100, 2, 169-176, doi: 10.1159/000323964.