Condition category
Neonatal Diseases
Date applied
05/01/2006
Date assigned
17/02/2006
Last edited
16/01/2014
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

Dr Samuel Ibhanesebhor

ORCID ID

Contact details

Wishaw General Hospital
Netherton street
Wishaw
ML2 0DP
United Kingdom

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 measures

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

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

Sponsor information

Organisation

NHS Lanarkshire Primary Care Operating Division (UK)

Sponsor details

Strathclyde Hospital
Airbles road
Motherwell
ML1 3BW
United Kingdom

Sponsor type

Government

Website

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

Results - basic reporting

Publication summary

2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21455007

Publication citations

  1. 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.

Additional files

Editorial Notes