Tolerance of milk feeds in preterm, very low birth-weight babies: the use of glycerine suppositories

ISRCTN ISRCTN47065764
DOI https://doi.org/10.1186/ISRCTN47065764
EudraCT/CTIS number 2005-000302-31
Secondary identifying numbers 04/S0101/37 (EudraCT number 2005-000302-31)
Submission date
05/01/2006
Registration date
17/02/2006
Last edited
16/01/2014
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Neonatal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Samuel Ibhanesebhor
Scientific

Wishaw General Hospital
Netherton street
Wishaw
ML2 0DP
United Kingdom

Study information

Study designProspective, open, randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typePrevention
Scientific title
Study objectivesDoes 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(s)Awaiting final approval
Health condition(s) or problem(s) studiedFeeding problems related to prematurity
InterventionGlycerine suppositories, control group will receive usual neonetal care following randomisation
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Glycerine suppositories
Primary outcome measureTime to achieve first full enteral feeds
Secondary outcome measures1. Number of episodes of abdominal distention
2. Oxygen requirements
3. Development of NEC
4. Episodes of sepsis
5. Growth
Overall study start date06/02/2006
Completion date06/02/2007

Eligibility

Participant type(s)Patient
Age groupNeonate
SexBoth
Target number of participants28
Key inclusion criteriaAll preterm babies born at Wishaw General Hospital at less than 32 weeks gestation
Key exclusion criteriaBabies 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
Date of first enrolment06/02/2006
Date of final enrolment06/02/2007

Locations

Countries of recruitment

  • Scotland
  • United Kingdom

Study participating centre

Wishaw General Hospital
Wishaw
ML2 0DP
United Kingdom

Sponsor information

NHS Lanarkshire Primary Care Operating Division (UK)
Government

Strathclyde Hospital
Airbles road
Motherwell
ML1 3BW
United Kingdom

ROR logo "ROR" https://ror.org/049prb569

Funders

Funder type

Government

NHS Lanarkshire Primary Care Operating Division 04/S0101/37

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/05/2011 Yes No